510(k) Pre-Market Notification Project

Osteova, Inc.
WedgeX™ Bone Wedge
510(k) Premarket Notification
Traditional 510(k)
Prepared by Group 5
Vanessa Chua
Sneha Iyer
Moon Jiao
Brandon MacAleese
Nitya Ramesh
Herman Tsang (correspondent)

Osteova, Inc.
Traditional 510(k)
Confidential Page 2
Table of Contents
Screening Checklist .................................................................................................................................... 7
Section 1 – Medical Device User Fee Cover Sheet (Form FDA 3601) ....................................................... 8
Section 2 – CDRH Premarket Review Submission Cover Sheet (Form FDA 3514)................................... 9
Section 3 – 510(k) Cover Letter................................................................................................................ 16
Section 4 – Indications for Use Statement ................................................................................................ 17
Section 5 – 510(k) Summary .................................................................................................................... 18
5.1 Device Description.......................................................................................................................... 18
5.2 Intended Use ................................................................................................................................... 19
5.3 Substantial Equivalence .................................................................................................................. 19
5.4 Technological Characteristics ......................................................................................................... 19
5.5 Performance Data............................................................................................................................ 19
Section 6 – Truthful and Accurate Statement............................................................................................ 20
Section 7 – Class III Summary and Certification...................................................................................... 21
Section 8 – Financial Certification or Disclosure Statement (Forms FDA 3454 and 3455) ...................... 22
Section 9 – Declarations of Conformity and Summary Reports (Form FDA 3654).................................. 23
Section 10 – Executive Summary ............................................................................................................. 24
10.1 Description of Device ................................................................................................................... 24
10.2 Technology ................................................................................................................................... 24
10.3 Indications for Use........................................................................................................................ 24
10.4 Substantial Equivalence ................................................................................................................ 25
Table 1: Device Comparison ............................................................................................................ 25
10.5 Summary of Performance Testing................................................................................................. 26

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Traditional 510(k)
Confidential Page 3
Table 2: Biocompatibility Testing ..................................................................................................... 26
Table 3: Bench Testing ..................................................................................................................... 26
Section 11 – Device Description............................................................................................................... 27
11.1 Description of the Device.............................................................................................................. 27
Figure 1: Engineering drawing for the WedgeX™ Bone Wedge for an Evans Procedure. There are
three holes for bone grafting material or biologics and a single hole for interfacing with the
installation tool................................................................................................................................. 28
Figure 2: Engineering drawing for the WedgeX™ Bone Wedge for a Cotton Osteotomy. There are
two holes provided for bone grafting material or biologics. ............................................................. 28
11.2 Technology ................................................................................................................................... 29
Table 4: Available WedgeX™ Sizes for use in an Evans Procedure or other similar opening wedge
procedure. Note: The thickness of each sizing tool is etched onto the tool........................................ 29
Table 5: Available WedgeX™ Sizes for use in a Cotton Osteotomy or other similar opening wedge
procedure. Note: The thickness of each sizing tool is etched onto the tool........................................ 29
11.3 Indication for Use ......................................................................................................................... 30
11.4 Device Packaging.......................................................................................................................... 30
I. Pouch............................................................................................................................................. 30
II. Dispenser Box .............................................................................................................................. 30
III. Outer Carton ............................................................................................................................... 30
Table 6: Device packaging validation activities ............................................................................... 31
Section 12 – Substantial Equivalence Discussion ..................................................................................... 32
Table 7: Predicate Device................................................................................................................. 32
Table 8: Device Comparison ............................................................................................................ 33
Table 9: SE Determination................................................................................................................ 34
Section 13 – Proposed Labeling................................................................................................................ 36

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Traditional 510(k)
Confidential Page 4
13.1 Labeling Description and Figures ................................................................................................. 36
Figure 3: Patient ID Label................................................................................................................ 36
Figure 4: Printed Tyvek®
Pouch ....................................................................................................... 37
Figure 5: Dispenser Box Printed Design .......................................................................................... 37
Figure 6: Outer Carton Label........................................................................................................... 38
Figure 7: Outer Carton Printed Design............................................................................................ 38
13.2 Package Insert ............................................................................................................................... 39
I. General Product Information ......................................................................................................... 39
II. Device Description....................................................................................................................... 39
III. Indications for Use...................................................................................................................... 40
IV. Contraindications........................................................................................................................ 40
V. Cautions ....................................................................................................................................... 40
VI. Precautions.................................................................................................................................. 40
VII. Adverse Events.......................................................................................................................... 41
VIII. Packaging, Sterilization, and Storage ....................................................................................... 41
IX. Surgical Techniques.................................................................................................................... 42
X. Patient Population ........................................................................................................................ 42
XI. Life of Device............................................................................................................................. 42
XII. Symbols Used on Packaging ..................................................................................................... 42
XIII. Contact Information ................................................................................................................. 43
Section 14 – Sterilization and Shelf Life................................................................................................... 44
14.1 Ethylene Oxide (EO) Sterilization ................................................................................................ 44
14.2 Shelf Life ...................................................................................................................................... 44

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Traditional 510(k)
Confidential Page 5
Section 15 – Biocompatibility................................................................................................................... 45
15.1 General Description ...................................................................................................................... 45
Table 10: Biocompatibility Testing ................................................................................................... 45
15.2 Test Details ................................................................................................................................... 46
I. Cytotoxicity................................................................................................................................... 46
II. Sensitization ................................................................................................................................. 46
III. Skin Irritation.............................................................................................................................. 46
IV. Acute Systemic Toxicity and Sub-acute/Sub-chronic Toxicity................................................... 47
V. Genotoxicity................................................................................................................................. 47
VI. Implantation................................................................................................................................ 47
VII. Carcinogenicity ......................................................................................................................... 47
15.3 Conclusion .................................................................................................................................... 47
Section 16 – Software............................................................................................................................... 48
Section 17 – Electromagnetic Compatibility and Electrical Safety........................................................... 49
Section 18 – Performance Testing: Bench ................................................................................................ 50
Table 11: Bench Testing ................................................................................................................... 50
I. Characterization and Fatigue of Spinal Intervertebral Body Fusion Devices, ASTM F2077-11.... 50
Figure 8: Static and Fatigue Testing Instrument. ............................................................................. 50
II. Axial and Torsion Testing of Bone Screws, ASTM F543 ............................................................ 51
III. Flexural Fatigue Testing Metallic Bone Plates, ASTM F382-99................................................. 52
Figure 9: Flexural Fatigue Testing Instrument................................................................................. 52
IV. Spinal Constructs – Static, Torsion, and Fatigue Testing, ASTM F1717.................................... 52
Section 19 – Performance Testing: Animal............................................................................................... 53

Osteova, Inc.
Traditional 510(k)
Confidential Page 6
Section 20 – Performance Testing: Clinical.............................................................................................. 54
Section 21 – List of Referenced Standards and Guidance Documents...................................................... 55

Osteova, Inc.
Traditional 510(k)
Confidential Page 7
Screening Checklist
Section Title Present N/A
1 Medical Device User Fee Cover Sheet (Form FDA 3601) X
2 CDRH Premarket Review Submission Cover Sheet (Form FDA 3514) X
3 510(k) Cover Letter X
4 Indications for Use Statement X
5 510(k) Summary or 510(k) Statement X
6 Truthful and Accurate Statement X
7 Class III Summary and Certification X
8 Financial Certification or Disclosure Statement (Forms FDA 3454 and 3455) X
9 Declarations of Conformity and Summary Reports (Form FDA 3654) X
10 Executive Summary X
11 Device Description X
12 Substantial Equivalence Discussion X
13 Proposed Labeling X
14 Sterilization and Shelf Life X
15 Biocompatibility X
16 Software X
17 Electromagnetic Compatibility and Electrical Safety X
18 Performance Testing – Bench X
19 Performance Testing – Animal X
20 Performance Testing – Clinical X
21 List of Referenced Standards and Guidance Documents X

Osteova, Inc.
Traditional 510(k)
Confidential Page 8
Section 1 – Medical Device User Fee Cover Sheet (Form FDA 3601)

Osteova, Inc.
Traditional 510(k)
Confidential Page 9
Section 2 – CDRH Premarket Review Submission Cover Sheet (Form FDA
3514)

Osteova, Inc.
Traditional 510(k)
Confidential Page 10

Osteova, Inc.
Traditional 510(k)

Osteova, Inc.
Traditional 510(k)
Section 3 – 510(k) Cover Letter
Food and Drug Administration
Center for Devices and Radiological Health
510(k) Document Mail Center (HFZ-401)
9200 Corporate Boulevard
Rockville, Maryland 20850
Re: Osteova, Inc.
WedgeX™ Bone Wedge Traditional 510(k) Submission
To whom it may concern:
I am submitting the following premarket notification for Osteova, Inc. of Los Angeles, California to
obtain FDA clearance to market the WedgeX™ Bone Wedge. One of the two copies of this submission
will be an electronic copy. The device is a class II device under 21 CFR 888.3030, titled bone fixation
plate. The device currently falls under product code HRS under the orthopedic device panel review.
The WedgeX™ Bone Wedge is substantially equivalent to the BIOFOAM®
Bone Wedge (Wright
Medical Technology, Inc. under K140531) cleared by FDA on July 9th
, 2014. The WedgeX™ Bone
Wedge does not incorporate any new technological characteristics, as compared to the predicate device.
Osteova, Inc. considers the information contained in this submission to be proprietary and not intended
for public disclosure, except for the 510(k) summary. Confidentiality is requested in accordance with 21
CFR 807.95.
To address inquiries or concerns, please contact the correspondent, Herman Tsang, at 213-123-4567 or by
email at herman.tsang@osteova.com.
Sincerely,
Herman Tsang
Director of Regulatory Affairs
Osteova, Inc.
123 Sample Street
Los Angeles
CA 90089
herman.tsang@osteova.com

Osteova, Inc.
Traditional 510(k)
Section 4 – Indications for Use Statement

Osteova, Inc.
Traditional 510(k)
Section 5 – 510(k) Summary
In accordance with the Food and Drug Administration Rule to implement provisions of the Safe Medical
Devices Act of 1990 and in conformance with 21 CFR 807.92, this information serves as a Summary of
Safety and Effectiveness for the use of the WedgeX™ Bone Wedge.
Submitted by: Osteova, Inc.
123 Sample Street
Los Angeles, CA 90089
Date: November 22, 2014
Contact Person: Herman Tsang
Director of Regulatory Affairs
herman.tsang@osteova.com
Proprietary Name: WedgeX™ Bone Wedge
Common Name: Plate, bone fixation; bone wedge (for foot)
Classification Name and Reference: 21 CFR 888.3030, Class II
Device Product Code, Device Panel: HRS, Orthopedic
Predicate Device: BIOFOAM®
Bone Wedge (K140531)
5.1 Device Description
WedgeX™ Bone Wedge is a foot-bone wedge that is surgically inserted into an osteotomy void and then
secured with an ancillary fixation that is compatible with various products by Osteova, Inc. The device is
used in procedures for mechanically realigning bones in the foot. The device’s structure is designed to
mimic the porosity of bone matter to facilitate its ingrowth and incorporation after its insertion into the
void. The device is made of a titanium metal foam. It is offered in two styles and a variety of widths and
thicknesses in order to accommodate different osteotomy procedures in the foot.
The accessories of this device include the ancillary fixation and screws. The ancillary fixation prevents
the wedge from becoming dislodged after insertion, and the screws secure the fixation in place. Although
the ancillary fixation and screws are not included in the package for WedgeX™ Bone Wedge, they can be
purchased separately and are compatible with the wedge and other products by Osteova, Inc. In addition
to the ancillary fixation and screws, required accessories that can be purchased separately for installing
the WedgeX™ device include void sizing tools to aid in determining the depth and thickness of the void,
and handles to assist with the placement of the device.
WedgeX™ is provided sterile and non-pyrogenic. There are multiple locations where bone-grafting
material or biologics may be applied by the physician.

Osteova, Inc.
Traditional 510(k)
5.2 Intended Use
The WedgeX™ Bone Wedge is indicated for internal bone fixation for bone fractures, fusions, or
osteotomies in the ankle and foot, such as opening wedge osteotomies of the bones of the foot including
Hallux Valgus; opening wedge of Medial Cuneiform or Cotton osteotomies; Lateral Column
Lengthening; Metatarsal/Cuneiform arthrodesis; opening wedge osteotomies of the bones of the foot
including osteotomies for Hallux Valgus; and nonunion of arthrodesis of the Midfoot including
Metatarsal Cuneiform arthrodesis. This device is indicated for use with ancillary fixation. This device is
provided sterile. This device is for prescription use only. The WedgeX™ Bone Wedge is not indicated for
use in the spine. The safety and effectiveness of the WedgeX™ Bone Wedge have not been established in
children, adolescents, or those who are pregnant or may become pregnant.
5.3 Substantial Equivalence
WedgeX™ Bone Wedge is substantially equivalent to the predicate, BIOFOAM®
Bone Wedge. The
devices have the same indications for use, are made of the same material, and are sterilized with
acceptable methods.
Testing rationale was provided to support the equivalence of the WedgeX™ Bone Wedge and shows that
no new questions of safety and effectiveness have been introduced with this device. The safety and
effectiveness of the WedgeX™ Bone Wedge are adequately supported by the testing rationale, substantial
equivalence information, materials information, and comparison of design characteristics provided within
this premarket notification.
5.4 Technological Characteristics
The WedgeX™ Bone Wedge is technologically substantially equivalent to the predicate device. Both
devices are identical in material.
5.5 Performance Data
The materials used in the manufacture of the WedgeX™ Bone Wedge are identical to those used in the
predicate device. The major material is titanium.
The device passed all biocompatibility tests. In accordance to ISO 10993-1:2009 and FDA G95-1
guidelines, the following biocompatibility tests were performed: Cytotoxicity, Sensitization,
Irritation/Intracutaneous Reactivity, Acute Systemic Toxicity, Sub-chronic Toxicity, Genotoxicity, and
Implantation.
The performance bench tests include Conformational Structure Analysis; Static, Torsion, and Fatigue
Testing; Flexural Fatigue Testing Metallic Bone Plates; Axial and Torsion Testing of Bone Screws; and
Characterization and Fatigue of Spinal Intervertebral Body Fusion Devices. WedgeX™ Bone Wedge
passed the performance tests and thus has structural integrity comparable to that of the predicate’s.
Sterilization by ethylene oxide has been validated for WedgeX™ Bone Wedge.

Osteova, Inc.
Traditional 510(k)
Section 6 – Truthful and Accurate Statement
I, Herman Tsang certify that, in my capacity as Director of Regulatory Affairs of Osteova, Inc., I believe
to the best of my knowledge, that all data and information submitted in the premarket notification are
truthful and accurate and that no material fact has been omitted.
Herman Tsang
(Signature)
Herman Tsang
(Typed Name)
November 22, 2014
(Date)
_______________________________
*(Premarket Notification [510(k)] Number)
*For a new submission, leave the 510(k) number blank.
Must be signed by a responsible person of the firm required to submit the premarket notification [e.g., not
a consultant for the 510(k) submitter].

Osteova, Inc.
Traditional 510(k)
Section 7 – Class III Summary and Certification
WedgeX™ Bone Wedge is classified as a Class II device. Therefore, Class III Summary and Certification
is does not required for this device.

Osteova, Inc.
Traditional 510(k)
Section 8 – Financial Certification or Disclosure Statement (Forms FDA 3454
and 3455)
No clinical studies were performed with WedgeX™ Bone Wedge. Therefore, Financial Certification of
Disclosure Statement is not required for this device.

Osteova, Inc.
Traditional 510(k)
Section 9 – Declarations of Conformity and Summary Reports (Form FDA
3654)
Declarations of Conformity and Summary Reports is not required for a Traditional 510(k).

Osteova, Inc.
Traditional 510(k)
Section 10 – Executive Summary
10.1 Description of Device
material or biologics may be applied by the physician, as shown in Figures 1 and 2 in Section 11 –
Description of the Device.
10.2 Technology
The WedgeX™ Bone Wedge is a sterilized, titanium metal foam wedge. Titanium is widely used for a
variety of biomedical implantation devices. Titanium is known for its strength and biocompatibility.
WedgeX™ includes multiple locations where either bone-grafting material may be applied to facilitate
natural bone growth after installation, or where biologics may be applied per discretion of the physician.
The rough surface of the wedge allows for a high coefficient of friction between the wedge and the bones
surrounding it, aiding to keep the wedge in place.
WedgeX™ comes in two styles and a variety of widths and thicknesses in order to accommodate different
osteotomy procedures in the foot. The sizing tools described in Section 11.1, Description of the Device,
are color-coded for ease of identification.
10.3 Indications for Use

Osteova, Inc.
Traditional 510(k)
10.4 Substantial Equivalence
Osteova, Inc. believes the WedgeX™ Bone Wedge to be substantially equivalent to its predicate.
Comparisons of the devices are tabulated below in Table 1 and also in Table 9 of Section 12 – Substantial
Equivalence Discussion.
Table 1: Device Comparison
Device BIOFOAM® Bone Wedge (Predicate) WedgeX™ Bone Wedge
Design Two styles and a variety of widths and
thicknesses. The accessories include
the ancillary fixation and screws.
One style and a variety of widths and
thicknesses. The accessories include the
ancillary fixation and screws.
Materials Titanium metal foam Titanium metal foam
Intended use The BIOFOAM®
Bone Wedge is
indicated for internal bone fixation for
bone fractures, fusions, or osteotomies
in the ankle and foot, such as opening
wedge osteotomies of the bones of the
foot including Hallux Valgus; opening
wedge of Medial Cuneiform or Cotton
osteotomies; Lateral Column
Lengthening; Metatarsal/Cuneiform
arthrodesis; opening wedge
osteotomies of the bones of the foot
including osteotomies for Hallux
Valgus; and nonunion of arthrodesis of
the Midfoot including Metatarsal
Cuneiform arthrodesis. This device is
indicated for use with ancillary
fixation. This device is provided
sterile. This device is for prescription
use only. The BIOFOAM®
Bone
Wedge is not indicated for use in the
spine. The safety and effectiveness of
the BIOFOAM®
Bone Wedge have not
been established in children,
adolescents, or those who are pregnant
or may become pregnant.
The WedgeX™ Bone Wedge is
arthrodesis; opening wedge osteotomies
of the bones of the foot including
osteotomies for Hallux Valgus; and
nonunion of arthrodesis of the Midfoot
including Metatarsal Cuneiform
arthrodesis. This device is indicated for
use with ancillary fixation. This device
is provided sterile. This device is for
prescription use only. The WedgeX™
Bone Wedge is not indicated for use in
the spine. The safety and effectiveness
of the WedgeX™ Bone Wedge have not
Size availability Two orientations and fifteen sizes Two orientations and twenty-one sizes
Anatomical Site Below the sinus tarsi, extending
proximal to the calcaneocuboid joint
Below the sinus tarsi, extending
Sterilization Provided sterile, unknown method Ethylene oxide
510(K) Number K140531 TBD

Osteova, Inc.
Traditional 510(k)
10.5 Summary of Performance Testing
WedgeX™ Bone Wedge was subjected to thorough biocompatibility and mechanical testing.
Performance Testing includes the biocompatibility tests and bench tests. Detailed descriptions of the
biocompatibility tests and bench tests are presented in Sections 15 and 18, respectively. WedgeX™ Bone
Wedge passed all the performance tests. Therefore, we conclude that it is substantially equivalent to its
predicate. Table 10 of Section – 15 Biocompatibility summarizes the tests performed, methods employed,
and results obtained (shown below in Table 2). Table 11 of Section 18 – Performance Testing: Bench
summarizes the performance bench tests that were performed with this device (shown below in Table 3).
Table 2: Biocompatibility Testing
Test Method Test
Sample
Animal Standard Result
Cytotoxicity MEM Test Leachate Cellular ISO-10993-
5:2009
Pass
Sensitization Maximization Leachate Guinea Pig ISO-10993-
10:2013
Pass
Irritation/Intracutaneous
Reactivity
Rabbit
Intracutaneous
Reactivity Test
Leachate Rabbit
ISO-10993-
10:2013 Pass
Acute Systemic
Toxicity
Mouse Systemic
Injection
Leachate Mouse ISO-10993-
11:2009
Pass
Sub-chronic Toxicity Mouse Systemic
Injection
11:2009
Pass
Genotoxicity Ames Reverse
Mutation
Leachate S. typhimurium ISO-10993-
3:2009
Pass
Implantation Implantation Test Leachate Rabbit ISO-10993-
6:2009
Pass
Table 3: Bench Testing
Test Test Method Result Status
Conformational Structure
Analysis
FEM
(Finite Element Method
Testing)
TBD Pass
Static, Torsion and Fatigue
Testing
ASTM F1717* As per manufacturing
specifications
Pass
Flexural Fatigue Testing
Metallic Bone Plates
ASTM F382-99 As per manufacturing
specifications
Pass
Axial and Torsion Testing of
Bone Screws
ASTM F543 As per manufacturing
specifications
Pass
Characterization and Fatigue
of Spinal Intervertebral Body
Fusion Devices
ASTM F2077 – 11*
As per manufacturing
specifications
Pass
*Although ASTM F2077-11 and ASTM F1717 are written for spinal implants, the same basic methods
outlined in these standards may be applied for testing of other bone implants such as the WedgeX™ Bone
Wedge.

Osteova, Inc.
Traditional 510(k)
Section 11 – Device Description
11.1 Description of the Device
material or biologics may be applied by the physician, as shown in Figure 1 and Figure 2 below.

Osteova, Inc.
Traditional 510(k)
Figure 1: Engineering drawing for the WedgeX™ Bone Wedge for an Evans Procedure. There are
three holes for bone grafting material or biologics and a single hole for interfacing with the
installation tool.
Figure 2: Engineering drawing for the WedgeX™ Bone Wedge for a Cotton Osteotomy. There are two
holes provided for bone grafting material or biologics.

Osteova, Inc.
Traditional 510(k)
11.2 Technology
The WedgeX™ Bone Wedge is a sterilized, titanium metal foam wedge. Titanium is widely used for a
variety of biomedical implantation devices. Titanium is known for its strength and biocompatibility.
WedgeX™ has multiple locations that allow for either bone-grafting material to be applied to facilitate
natural bone growth after installation, or for biologics to be applied per discretion of the physician. The
rough surface of the wedge allows for a high coefficient of friction between the wedge and the bones
surrounding it, aiding to keep the wedge in place.
WedgeX™ comes in two styles and a variety of widths and thicknesses in order to accommodate different
osteotomy procedures in the foot. The sizing tools mentioned above in Section 11.1, Description of the
Device, are color-coded for ease of identification. Tables 4 and 5, below, outline the different dimensions
for the two different styles of bone wedges:
Table 4: Available WedgeX™ Sizes for use in an Evans Procedure or other similar opening wedge
procedure. Note: The thickness of each sizing tool is etched onto the tool.
Part Number
Color Indicator for
Sizing Tools
Width x Depth (mm) Thickness (mm)
WXEP16-08 Red ■ 16x16 8
WXEP16-10 Red ■ 16x16 10
WXEP16-12 Red ■ 16x16 12
WXEP18-08 Orange ■ 18x18 8
WXEP20-08 Gold ■ 20x20 8
WXEP20-10 Gold ■ 20x20 10
WXEP20-12 Gold ■ 20x20 12
WXEP22-08 Green ■ 22x22 8
WXEP22-10 Green ■ 22x22 10
WXEP22-12 Green ■ 22x22 12
Table 5: Available WedgeX™ Sizes for use in a Cotton Osteotomy or other similar opening wedge
procedure. Note: The thickness of each sizing tool is etched onto the tool.
Part Number Color Indicator for
Sizing Tools
Length
(mm)
Dorsal
Width (mm)
Plantar Width
(mm)
Thickness (mm)
WXCO16-45 Blue ■ 16 14 10 4.5
WXCO16-55 Blue ■ 16 14 10 5.5
WXCO16-65 Blue ■ 16 14 10 6.5
WXCO18-45 Purple ■ 18 14 10 4.5
WXCO18-55 Purple ■ 18 14 10 5.5
WXCO18-65 Purple ■ 18 14 10 6.5
WXCO20-45 Black ■ 20 14 10 4.5
WXCO20-55 Black ■ 20 14 10 5.5
WXCO20-65 Black ■ 20 14 10 6.5

Osteova, Inc.
Traditional 510(k)
11.3 Indication for Use
11.4 Device Packaging
I. Pouch
WedgeX™ is placed inside a Tyvek®
pouch with a high-barrier foil backing. Using a high-barrier foil
pouch mitigates the risk of the titanium-foam bone wedge damaging the pouch. An adhesive label
containing three removable labels for patient medical files is adhered to the back foil-side of the pouch.
The proposed information for the patient ID labels is given in Figure 3.
The device is for single use only. The Tyvek®
pouch is pre-printed with the proposed labeling given in
Figure 4. The pouch can be peeled open via the chevron-style seal (directions given) when the device is to
be used. The pouch is compatible for ethylene oxide sterilization. It has consistent peel strength and
adequate seal integrity according to ASTM F1886/F1886M - Standard Test Method for Determining
Integrity of Seals for Flexible Packaging by Visual Inspection. Once the device is packaged in the pouch,
it is packaged in a paperboard dispenser box and then in a corrugate box.
II. Dispenser Box
After being sealed in the pouch, WedgeX™ is placed inside a small dispenser box. The box is stored in a
surgical environment and features a perforated window that can be torn away to allow for quick retrieval
prior to a procedure. The dispenser box is made of paperboard and is printed with corporate identity and
product identification information on four sides, excluding the top and bottom. The proposed printing is
shown in Figure 5.
III. Outer Carton
Four dispenser boxes are packaged into a single outer carton, which is sent to be sterilized by ethylene
oxide according to the standards in AAMI/ANSI/ISO 11135 Standards: Sterilization of health care
products - Ethylene oxide. The outer carton is made of cardboard that is not sterile. It follows the ISO
Standard 11607: Packaging for terminally sterilized medical devices. The outer carton is labeled on one
end and is printed with the corporate identity on four sides, excluding the top and bottom. The proposed
labeling and carton printing are given in Figure 6 and Figure 7, respectively.

Osteova, Inc.
Traditional 510(k)
See Table 6 below for a summary of the different validation activities that were completed for the
packaging of the device.
Table 6: Device packaging validation activities
Test Name Reason(s) for Testing Standards Tested
Vibration Simulate the vibrations that could
normally be experienced by the
device during transportation to
evaluate the effects it may have on
the packaging from the outer
carton to the device pouch.
ASTM D4728: Test Method for Random
Vibration Testing of Shipping Containers
Drop/Shock Simulate the potential hazard of
the device being dropped from
specific heights to determine if the
packaging (cartons) adequately
protects the contents within,
preventing damage to the device
and pouch.
ASTM D5276: Test Method for Drop Test
of Loaded Containers by Free Fall
Sterility To ensure that the device is sterile
after undergoing ethylene oxide
sterilization.
To ensure that EO residuals are
properly outgassed from the
device.
ISO 11737-2: Sterilization of medical
devices - Microbiological methods - Part 2:
Tests of sterility performed in the
definition, validation and maintenance of a
sterilization process
EN 556: Sterilization of medical devices -
Requirements for medical devices to be
designated "STERILE" - Part 1:
Requirements for terminally sterilized
medical devices
ISO11135-1: Sterilization of health care
products - Ethylene oxide - Part 1:
Requirements for development, validation
and routine control of a sterilization
process for medical devices.
ISO 10933-7: Biological evaluation of
medical devices - Part 7: Ethylene oxide
sterilization residuals.
Pouch Integrity To evaluate the strength of the
pouch seal at multiple points
around the seal and determine if
there are any pinholes in the
Tyvek®
or voids in the seal.
ASTM F88/F88M: Standard Test Method
for Seal Strength of Flexible Barrier
Materials
Biocompatibility To determine that the packaging of
the device does not have any
adverse effects on the
biocompatibility of the device.
ASTM F2475 – 05: Standard Guide for
Biocompatibility Evaluation of Medical
Device Packaging Materials

Osteova, Inc.
Traditional 510(k)
Section 12 – Substantial Equivalence Discussion
Date of preparation November 22, 2014
Trade name WedgeX™ Bone Wedge
Common name Osteotomy Bone Wedge
Classification name Plate, bone fixation; bone wedge (for foot)
Device classification Class II
Product classification 888.3030
Product code HRS
Classification panel Orthopedic devices
Establishment Registration Number TBD
Substantially Equivalent to the predicate described in Table 7: Predicate Device
Table 7: Predicate Device
Predicate device Model number 510(k) number 510(k) holder Clearance date
BIOFOAM®
Bone
Wedge
135765-3 K140531 Wright Medical
Technology, Inc.
July 9, 2014
secured with an ancillary fixation. The device is used in procedures for mechanically realigning bones in
the foot.
For purposes of this submission, WedgeX™ Bone Wedge was compared to BIOFOAM®
Bone Wedge. A
detailed comparison is given below in Table 8: Device Comparison, and the process of determination of
substantial equivalence is given below in Table 9: SE Determination.

Osteova, Inc.
Traditional 510(k)
Table 8: Device Comparison
Device BIOFOAM® Bone Wedge (Predicate) WedgeX™ Bone Wedge
Design Two styles and a variety of widths and
thicknesses. The separate accessories
include the ancillary fixation and
screws.
One style and a variety of widths and
thicknesses. The separate accessories
include the ancillary fixation and
screws.
Materials Titanium metal foam Titanium metal foam
Intended use The BIOFOAM®
Bone Wedge is
arthrodesis; opening wedge
osteotomies of the bones of the foot
including osteotomies for Hallux
Valgus; and nonunion of arthrodesis of
the Midfoot including Metatarsal
Cuneiform arthrodesis. This device is
indicated for use with ancillary
fixation. This device is provided
sterile. This device is for prescription
use only. The BIOFOAM®
Bone
Wedge is not indicated for use in the
spine. The safety and effectiveness of
the BIOFOAM®
Bone Wedge have not
The WedgeX™ Bone Wedge is
arthrodesis; opening wedge osteotomies
of the bones of the foot including
osteotomies for Hallux Valgus; and
nonunion of arthrodesis of the Midfoot
including Metatarsal Cuneiform
arthrodesis. This device is indicated for
use with ancillary fixation. This device
is provided sterile. This device is for
prescription use only. The WedgeX™
Bone Wedge is not indicated for use in
the spine. The safety and effectiveness
of the WedgeX™ Bone Wedge have not
Size availability Two orientations and fifteen sizes Two orientations and twenty-one sizes
Anatomical Site Below the sinus tarsi, extending
Below the sinus tarsi, extending
Sterilization Provided sterile, unknown method Ethylene oxide
510(K) Number K140531 TBD

Osteova, Inc.
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Table 9: SE Determination
Questions Answers BIOFOAM® Bone Wedge WedgeX™ Bone Wedge
Is the predicate device
legally marketed?
Yes Wright Medical
Technology, Inc.
K140531
Osteova, Inc.
Do the devices have
the same intended use?
Yes The BIOFOAM®
Bone
Wedge is indicated for
internal bone fixation
The WedgeX™ Bone
Wedge is indicated for
internal bone fixation
Do the devices have
the same technological
characteristics?
Yes Design:
Two styles, a variety of
widths and thicknesses, with
accessories purchased and
packaged separately
Material characteristics:
High coefficient of friction
Porosity of the
osteoconductive matrix
Biocompatible
Sterile
Design:
Two styles, a variety of
widths and thicknesses, with
accessories purchased and
packaged separately
Material characteristics:
High coefficient of friction
Porosity of the
osteoconductive matrix
Biocompatible
Sterile
No Fifteen sizes available Twenty-one sizes available
Do the different
technological
characteristics of the
devices raise different
questions of safety and
effectiveness?
No Biocompatibility and
performance testing were
conducted, and the results do
not raise any new questions
of safety or effectiveness.
Biocompatibility and
performance testing were
conducted, and the results do
not raise any new questions
of safety or effectiveness.
Are the methods
acceptable, and do the
data demonstrate
substantial
equivalence?
Yes The methods are acceptable,
and the data demonstrate
substantial equivalence.
The methods are acceptable,
and the data demonstrate
substantial equivalence.

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Conclusion
The characteristics of WedgeX™ Bone Wedge are identical to those of the predicate device in almost all
categories. The device has the same intended use as its predicate. Because it is composed of the same
materials, the device is biocompatible, like its predicate. Also, packaging and labeling of the device are
the same as those of its predicate. Much like its predicate, the device requires the use of special
accessories, such as ancillary fixation and screws that prevent the wedge from becoming dislodged after
insertion and that secure the fixation in place, and different tools for sizing and handling of the device.
These accessories are purchased and packaged separate from WedgeX™ Bone Wedge.
Compared to BIOFOAM®
Bone Wedge, WedgeX™ Bone Wedge comes in a larger range of sizes to
accommodate various operative procedures. However, WedgeX™ Bone Wedge passed biocompatibility
and performance tests that are discussed in Section 15 and Section 18 and hence is as safe as its predicate.
Based on the comparison to its predicate, we conclude that the design characteristics of WedgeX™ Bone
Wedge do not raise any new questions of safety or effectiveness. Therefore, we conclude that it is
substantially equivalent to its previously cleared predicate.

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Section 13 – Proposed Labeling
13.1 Labeling Description and Figures
WedgeX™ comes with labels for patient medical files, an outer carton label, printed Tyvek®
pouches
with device information, and a package insert inside a plastic sleeve that is adhered to each dispenser box.
The labels for patient medical files are printed with basic device information and have fields for patient
information to be filled out by the physician. These labels are detached from the adhesive label and are
placed in a patient’s medical file. The outer carton label and printed Tyvek®
pouches display information
about the WedgeX™ bone wedge. The package insert contains detailed information regarding the device
including a description, caution statement(s), indications/contraindications, explanation of any symbols
used, etc. as explained in Section 13.2, Package Insert. The proposed designs for the patient ID labels,
printed Tyvek®
pouch, outer carton label, and printed boxes are shown in the following figures.
WedgeX™ has a shelf life expiration date of 5 years and is labeled accordingly on the pouch printing and
the outer carton label. The device may be used up until the last day of the month that is shown on the
labeling.
Figure 3: Patient ID Label

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Figure 4: Printed Tyvek®
Pouch
Figure 5: Dispenser Box Printed Design

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Figure 6: Outer Carton Label
Figure 7: Outer Carton Printed Design

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13.2 Package Insert
I. General Product Information
The device provided is to be used for correcting deformities in foot structure and reducing pain for many
patients. Although widely recognized as a successful treatment method for these procedures, the implants
are manufactured from metal and so cannot be expected to perform as well as normal, healthy bone after
fusion occurs.
Evaluation of the risks/benefits associated with the use of this device must be performed by the surgeon.
As implantation of the WedgeX™ Bone Wedge will facilitate bone fusion post-operatively, the surgeon
must consider the following:
● The initial sizing of the required implant is critical to the effectiveness of the device.
● Patient occupation can affect the device, ancillary fixation, or both if the occupation requires the
patient to repeatedly strain his or her muscles. The intent of the device is not to restore full
function as compared with normal, healthy bone, and as such the patient should not hold high
expectations for post-operative functionality.
● Patient mental stability should be considered because of the chance that the patient will not
follow all recommended limitations and/or precautions, which can lead to failure of the device or
other complications.
 Whether or not the patient’s body will be sensitive to the implant as a foreign body
II. Device Description
material or biologics may be applied by the physician.

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III. Indications for Use
IV. Contraindications
● Infection
● Physiologically or psychologically inadequate patient
● Deficient skin, bone, or neurovascular status
● Severely damaged tendons
● Possibility for a more conservative treatment
● Children or adolescent patients, i.e. patients who are still growing
 Patients who normally have a high level of activity
V. Cautions
Federal law (USA) restricts this device to sale by or on the order of a physician.
VI. Precautions
● To mitigate potential complications or adverse reactions of the implanted device, follow the
instructions for use provided in product literature.
● It is the responsibility of the surgeon to evaluate the medical status, mental and physical, of each
patient and to be knowledgeable about implant surgery and any potential complications.
Understand that additional surgeries may be necessary to correct or replace the implant.
● Do NOT use the WedgeX™ Bone Wedge if excessive loading cannot be prevented.
● The intent of this implant surgery is to correct deformities in foot structure and reduce pain in
patients with such deformities. This is established by fusion of the bone to the implant. Excessive
forces can lead to delayed or failed bone fusion. Excessive forces may be a result of poor support,
joint instability, incorrect sizing, and overactivity.
● Proper use of the ancillary fixation during surgery is essential to the success of the implant.
● Following instructions for use provided by Osteova, Inc., proper implant sizing, stabilization of
deformities, and avoiding flawed implant surfaces will minimize the potential for post-operative
complications.
● It is imperative that the surgeon obtains informed consent for use of the device and adequately
explains all potential complications and adverse events with the patient, prior to surgery.

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● Clinical results of the device depend on the technique of the surgeon, pre- and post-operative
care, the chosen implant, patient evaluation, and daily activity.
● Inspect the device prior to use for any damages or defects.
● If it is necessary to remove an implant, inspect the device immediately after removal from the
patient for any damages.
● If the device is damaged or defective, retain it to assist with the analysis to be conducted by
Osteova, Inc.
● If necessary, discuss with the patient the potential risks of not retrieving a fragmented device.
This includes but is not limited to: location of the fragment, size of the fragment, events which
can cause subsequent injury, and procedures such as an MRI that should be avoided when
metallic fragments are of concern.
● Concern of Magnetic Resonance Environments
o The devices described in this package insert have not been evaluated for safety and
compatibility in a Magnetic Resonance (MR) environment. The devices described in this
package have not been tested for heating or migration when exposed to a MR environment.
VII. Adverse Events
As with any surgical procedure, there is a risk for adverse events associated with the surgery performed.
In regard to the WedgeX™ Bone Wedge, some potential adverse events associated with use of this device
include but are not limited to:
● Fracture of the implant
● Infection of the implant site
● Inflammation at the implant site
● Dislocation of the implant, requiring additional surgery to correct it
● Bone resorption/over-proliferation
● Allergic reaction(s) to the implant
● Embolism
● Migration of particulate debris due to normal wear, resulting in an immune response
● Unexpected immune response to the foreign body (the implant)
VIII. Packaging, Sterilization, and Storage
The WedgeX™ Bone Wedge is provided sterilized by ethylene oxide. Individual devices are packaged in
a Tyvek®
pouch with a high-barrier foil backing. Multiple pouches come packaged in a dispenser box to
allow for easy retrieval when needed. WedgeX™ has a shelf life expiration date of 5 years and is labeled
accordingly on the pouch printing and the outer carton label. The device may be used up until the last day
of the month that is shown on the labeling.
It is recommended to inspect the pouch integrity prior to opening. If a pouch has any cuts or rips that
might compromise sterility, or if there are any voids in any of the seals on the pouch, contact the
manufacturer for further instructions. Only use a device if the package integrity has not been
compromised. The pouches should be opened using proper aseptic operating room (OR) technique and
only after determining the proper size needed.

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The WedgeX™ Bone Wedge is for single use only and should never be re-used. It should never be re-
sterilized after being in contact with bodily tissues or fluids.
The WedgeX™ Bone Wedge should be stored in a cool, dry location (41° - 77°F [5°-25°C]). Products
should be protected from sunlight and be located in a clean environment.
IX. Surgical Techniques
 Proper aseptic OR technique should be used when opening the product pouch.
 Specific sizing procedure as outlined in the instructions for use of the WedgeX™ Bone Wedge
must be followed.
X. Patient Population
The safety and effectiveness of the WedgeX™ Bone Wedge have not been established for the following
patient populations:
 Patients who are pregnant or may become pregnant
 Children and adolescent patients, i.e. patients who are still growing
XI. Life of Device
The WedgeX™ Bone Wedge is intended to be a permanent implanted device because the device
promotes bone growth around and throughout its porous structure. The device should be surgically
removed if the patients’ condition is not improved due to improper sizing, if the device is causing
inflammation or other adverse events to the patient, or if the device sustains damage after implantation
such as fracture. Contact the manufacturer with any questions regarding the removal of the device.
XII. Symbols Used on Packaging
This symbol indicates that the device should not be used more than once.
This symbol indicates that the device is sterilized by ethylene oxide.
This symbol indicates that the instruction manual should be referenced.
This symbol indicates to keep the product out of direct sunlight.
This symbol indicates the temperature range in which the device should be stored.
This symbol indicates that the product should not be used if the package is damaged.
This symbol indicates that the device is for prescription use only.
This symbol indicates to take caution and consult accompanying documents.

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This symbol represents the manufacturer’s address.
This symbol represents the List or Reference number of the device.
This symbol represents the Lot Number of the device
This symbol represents the Expiration Date, with respect to the device’s sterilization.
This symbol represents that the device can be marketed in certain European countries.
This symbol indicates the Authorized European Representative.
This symbol indicates to prevent the package from getting wet.
This symbol indicates that the contents of the package are fragile and to handle with care.
XIII. Contact Information
Osteova, Inc.
123 Sample Street
Los Angeles,
CA 90089
1-800-OSTEOVA
www.osteovainc.com/products/complaints.htm

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Section 14 – Sterilization and Shelf Life
14.1 Ethylene Oxide (EO) Sterilization
The WedgeX™ Bone Wedge is provided sterile by ethylene oxide gas. The validation of this process is in
accordance with ISO 11737-2: Sterilization of medical devices - Microbiological methods - Part 2: Tests
of sterility performed in the definition, validation and maintenance of a sterilization process, and EN 556:
Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1:
Requirements for terminally sterilized medical devices.
The device is sterilized in three full-cycles to assure sterility of the product. Validation for this level of
sterilization was completed in two stages: 1) three half-cycles were run to confirm a Sterility Assurance
Level of at minimum 10-6
; and 2) three full-cycles were run in order to provide assurance of product and
package integrity and determine that there are acceptable EO residual levels. The validation procedure
was completed in accordance with ISO11135-1: Sterilization of health care products - Ethylene oxide -
Part 1: Requirements for development, validation and routine control of a sterilization process for
medical devices. Determination of EO residual level after full-sterilization of the device was completed as
outlined in ISO 10933-7: Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization
residuals.
Bioburden testing of the device was also conducted to provide assurance that the acceptable limits of
biological contaminants are upheld.
Validation protocols and reports for the sterilization process and bioburden testing, although not included
in this premarket notification, will be made available upon request.
14.2 Shelf Life
The WedgeX™ Bone Wedge has a maximum shelf life of 5 years from the date of sterilization. The
device may be used up until the last day of the month that is shown on the labeling. In compliance with
the standards of ASTM F1980: Standard Guide for Accelerated Aging of Sterile Barrier Systems for
Medical Devices, accelerated aging studies for three years and five years were performed to determine
product integrity over its lifespan, with acceptable results. A real-time aging study is currently in process
to verify the results found in the accelerated aging studies. The reports for the stability tests are not
provided in this submission but will be made available upon request.

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Section 15 – Biocompatibility
15.1 General Description
WedgeX™ Bone Wedge is a permanent bone implant and therefore directly contacts the patient.
Biocompatibility of the patient-contacting material is evaluated. The biocompatibility tests have
been performed in compliance with the biocompatibility matrix from United States Food and
Drug Administration Blue Book Memorandum G95-1, International Standards
Organization 10993-1 and 10993-12.
The implanted device directly and permanently contacts tissue/bone, hence the following
evaluation tests to verify any toxic effects the device might cause on cells upon implant.
The following table summarizes the tests performed, methods employed, and results obtained.
Table 10: Biocompatibility Testing
Test Method Test
Sample
Animal Standard Result
Cytotoxicity MEM Test Leachate Cellular ISO-10993-
:2009
Pass
Sensitization Maximization Leachate Guinea Pig ISO-10993-
10:2013
Pass
Irritation/Intracutaneous
Reactivity
Rabbit
Intracutaneous
Reactivity Test
Leachate Rabbit
ISO-10993-
10:2013 Pass
Acute Systemic
Toxicity
Mouse Systemic
Injection
11:2009
Pass
Sub-chronic Toxicity Mouse Systemic
Injection
11:2009
Pass
Genotoxicity Ames Reverse
Mutation
Leachate S. typhimurium ISO-10993-
3:2009
Pass
Implantation Implantation Test Leachate Rabbit ISO-10993-
6:2009
Pass

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15.2 Test Details
The tests were performed according to ISO 10993 standards. The extract was prepared at X° C for Y
hours from ‘#’ number of rings in sesame oil.
I. Cytotoxicity
This test was performed using the MEM elution method to evaluate any toxic effects of metal bone
implant on growth of body cells. The extracts were filtered and placed in contact with a monolayer of L-
929 cells (mouse fibroblasts). The cells were incubated at 37 ± 2 ºC in 5 ± 1% CO2 for 72 ± 3 hours.
The cells were then scored for cytopathic effect. There was no sign of any cell damage, and thus we
consider our implant to be non-cytotoxic for body cells. A copy of the test report is not included in the
document but can be provided upon request.
II. Sensitization
Sensitization tests estimate the potential for contact sensitization of devices through the testing of
appropriate materials or extracts. Guinea pigs were exposed to the extract at 37°C for 72 hours, twice
within a 2-week period (Inductions I and II). The animals were re-exposed (challenged) 10-14 days after
Induction II by placing fresh extract in contact with previously unexposed skin. Over a 72-hour period,
the animals were observed for signs of a delayed allergic response when compared to a control group. If
the test results were equivocal, a re-challenge could be conducted within 7-10 days of the initial
challenge. Twelve animals were used, 6 irritant controls and 6 negative controls. Extract options
included normal saline and cottonseed oil. The turnaround time was 54 days (GLP). The test results
indicate the material is non-sensitizing. A copy of the test report is not included in the document but can
be provided upon request.
III. Skin Irritation
An extract of the device or biomaterial was prepared in up to 4 standard USP extraction solutions and
injected intracutaneously into rabbits to assess the irritancy of extractable compounds that might exist in
the biomaterial. The animals were observed for dermal reactions over a 72-hour period. The animals
exposed to the test article extract did not show significant signs of irritation above those observed in the
concurrent test control groups. The results indicated that the material is a non-irritant and does not
induce any kind of subcutaneous reaction. Extract options included normal saline, 5% ethanol in saline,
cottonseed oil, and polyethylene glycol. The turnaround time was 29 days (GLP). A copy of the results
is not included in the document but can be provided upon request.

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IV. Acute Systemic Toxicity and Sub-acute/Sub-chronic Toxicity
Multiple extracts of a device were prepared with standard polar and/or non-polar vehicles and injected
into 6 male and 6 female mice over the test time period. Two similar control groups were also injected
with the control vehicle. The extract conditions were administered at 37°C for 72 hours. The animals
were observed during the test time period for signs of toxicity and were subjected to a gross observation
at study termination. The animals were tested for their weight, survival, clinical observations, and gross
necropsy. Other parameters evaluated include clinical chemistry and hematology. Extract options
included normal saline and cottonseed oil. A copy of the test report is not included in the document but
can be provided upon request.
V. Genotoxicity
Genotoxicology tests evaluate the ability of a material to cause mutation or gross chromosomal damage.
Any materials intended for implantation or long term exposure should be evaluated for mutagenic
properties. The ISO Bacterial Reverse Mutation test was performed according to ISO 10993-3 using
OECD test method 471. Tester strains of bacteria (5 S. typhimurium or 4 S. typhimurium and 1 E. coli,
or 5 S. typhimurium and 1 E. coli) were exposed to the extracts of the test material in the presence and
absence of an exogenous metabolic activation system. One dose level of the test article per extract and
both positive and negative controls were used. The turnaround time was 28 days (GLP). A copy of the
test report is not included in the document but can be provided upon request.
VI. Implantation
The purpose of this study is to evaluate the potential for local effects of a test article, in direct contact
with skeletal muscle for an extended duration. Biomaterial was implanted intramuscularly into rabbits to
assess the reaction of the surrounding tissue. The implants remained in the muscle for the sponsor-
designated time period. Scoring of the sample and control reactions were the gross observations.
Histopathologic evaluation and photomicrographs (gross and histologic) will also be provided at the
request of the sponsor. The final analysis of the local effect of the test article is based on the clinical,
gross, and histopathology data. Microscopic evaluation will include such things as cell type, cell
distribution, and fibroplasia calcification. The turnaround time was 49 days. A copy of the test report is
not included in the document but can be provided upon request.
VII. Carcinogenicity
Carcinogenicity testing was not performed because the Genotoxicity test results were acceptable.
15.3 Conclusion
Metal bone implants are typically constructed of materials with known biocompatibility and history of
use in other devices. These materials have undergone biocompatibility tests in accordance with the FDA
biocompatibility guidance on ISO 10993-1, “Biological Evaluation of Medical Devices Part 1:
Evaluation and Testing." The above mentioned results show our device to be biocompatible for use in
human body and are as safe as the predicate device.

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Section 16 – Software
There is no software associated with this device. Therefore, software validation is not required for this
device.

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Section 17 – Electromagnetic Compatibility and Electrical Safety
There is no electric component associated with the WedgeX™ Bone Wedge.

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Section 18 – Performance Testing: Bench
The table below summarizes the performance bench tests that were performed with this device.
Table 11: Bench Testing
Test Test Method Result Status
Conformational Structure
Analysis
FEM
(Finite Element Method
Testing)
TBD Pass
Static, Torsion and Fatigue
Testing
ASTM F1717* As per manufacturing
specifications
Pass
Flexural Fatigue Testing
Metallic Bone Plates
ASTM F382-99 As per manufacturing
specifications
Pass
Axial and Torsion Testing of
Bone Screws
ASTM F543 As per manufacturing
specifications
Pass
Characterization and Fatigue
of Spinal Intervertebral Body
Fusion Devices
ASTM F2077 – 11*
As per manufacturing
specifications
Pass
*Although ASTM F2077-11 and ASTM F1717 are written for spinal implants, the same basic methods
outlined in these standards may be applied for testing of other bone implants such as the WedgeX™ Bone
Wedge.
I. Characterization and Fatigue of Spinal Intervertebral Body Fusion Devices, ASTM F2077-11
This standard specifies a number of different static and dynamic tests to provide a mechanical comparison
between different fusion devices. The tests include:
● Axial-Compression
● Compression-Shear
● Torsion Testing
Figure 8: Static and Fatigue Testing Instrument. This axial-torsion
apparatus, the ElectroPuls™ E10000 Linear-Torsion All-Electric Dynamic
Test Instrument, allowed static and fatigue testing on the WedgeX™ Bone
Wedge. This system was combined with a temperature controlled bath,
which provided a stable environment for simulation of in vivo conditions.
With the use of specialized test fixtures, the combined axial-torsional
actuator in the crosshead allowed for conducting characterization in axial
compression, compression-shear, or compression-torsion tests modes. The
testing system allowed for mounting of the Biaxial Dynacell™ load cell on
the end of the moving axial-torsional actuator and automatically
compensated for errors caused by inertial loading.

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II. Axial and Torsion Testing of Bone Screws, ASTM F543
ASTM F543-07 Test A1: “Test Method for Determining the Torsional Properties of Metallic Bone
Screws” requires the screw to be sufficiently clamped and a rotational velocity between 1 and 5 rpm to be
applied until specimen failure and to measure the torque profile and the rotational angle.
ASTM F534-07 Test A2: “Test Method for Driving Torque of Medical Bone Screws” measures the
torque required to insert and remove the screw with a constant rotational velocity between 1 and 5 rpm,
while maintaining an axial load of no more than 10 N in compression.
ASTM F543-07 Test A3: “Test Method for Determining the Axial Pull-out Strength of Medical Bone
Screws” measures the force required to axially remove the screw that has been fully inserted in the test
block using the method from Test A2. The pull-out fixture then applies a tensile load at a constant rate of
5 mm/min until the failure of the bone screw or removal from the test block.
ASTM F543-07 Test A4:“Test Method for Determining the Self-Tapping Performance of Self-Tapping
Medical Bone Screws” specifies the procedure to evaluate the axial loading required to engage a self-
tapping bone screw into a standard laboratory material. Although considered a simple clinical procedure,
reproduction in vitro results in a relatively complex motion due to the interaction between the rotation and
linear axes of a test machine. The test requires a continuous rotational velocity of up to 30 rpm, while the
axial load is incremented during the insertion at a rate of 2 N/s. The objective of the test is to record the
torque profile as the bone screw is inserted into the material and then removed.
The ElectroPuls™ E10000 Linear-Torsion machine is an all-electric dynamic test system that provides a
unique linear and torsion actuator system that is capable of synchronized linear and multi-rotation testing
and is the ideal platform for performing the full range of tests prescribed by the standard. The combined
actuator package is mounted in the upper crosshead of the machine, leaving the base clear for mounting of
the biaxial Dynacell™ load cell and the fixtures to hold the material and bone screw. We control the test
system by using WaveMatrix™ Dynamic Test Software. This provides the ability to easily set up the
multi-axial tests as a series of steps and displays the required information as a test proceeds. Special
fixtures are used to clamp the material to the biaxial load cell and a drill chuck used for the drive bits.

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III. Flexural Fatigue Testing Metallic Bone Plates, ASTM F382-99
Testing was based on standard ASTM F382 - Standard Specification and Test Method for Metallic Bone
Plates. The test fixture accurately replicated bending movement during a single cycle test, as well as
fatigue evaluation of the plate material and design. The four-point bending fixture is comprised of two
loading rollers near the center of the loading fixture and two support rollers at the ends of the fixture. The
rollers are available in various sizes to cater for different size bone plates.
Figure 9: Flexural Fatigue Testing Instrument. This apparatus was
designed for use with our 8870 Series Servohydraulic Test Systems,
which is ideally suited to both static and dynamic tests. The setup can also
incorporate a deflectometry system (both in and out of an environmental
bath) to measure central deflection of the fixation device.
IV. Spinal Constructs – Static, Torsion, and Fatigue Testing, ASTM F1717
During normal patient activity, spinal constructs can be subjected to high in vivo loading, which may
result in catastrophic failure. Simple static testing must be performed to evaluate the compressive, tensile
and torsional loading required to fracture the spinal construct.
Service life testing of spinal constructs is critical, as fatigue failure is more common than catastrophic
failure. Loading is typically applied with a constant-amplitude, load-controlled sinusoidal waveform,
running in excess of five million cycles.
ASTM F1717, Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model, specifies
methods for both the static and fatigue testing of spinal implant assemblies.
For the majority of spinal construct testing, ultra-high molecular weight polyethylene (UHMWPE) blocks
were used, rather than vertebrae, to eliminate the variances that bone properties and geometry may
introduce. Static software test packages, such as Bluehill®
, were used to record load-displacement curves
and to perform calculations required by the ASTM standard.
A fatigue tester with a high-speed closed-loop multi-channel controller called MTESTQuattro®
Dynamic
was used. MTESTQuattro®
produced sine, square, and triangular waveforms based on force,
displacement, torque, or angle amplitude control. Users can manually adjust control gains and end point
values on the fly or activate amplitude control, so that the controller automatically adjusts the end point
values to ensure waveform amplitudes stay within tolerance. Biaxial systems employ two axes of control
that can be programmed to operate independently or in unison.

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Section 19 – Performance Testing: Animal
Performance testing using animals was not conducted for this device.

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Section 20 – Performance Testing: Clinical
Clinical performance testing was not required or performed for this device.

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Section 21 – List of Referenced Standards and Guidance Documents
1. ISO 10993-1:2009 - Biological evaluation of medical devices - Part 1: Evaluation and testing within
a risk management process
2. FDA G95-1 – 510(k) Memorandum: Table 1 Initial Evaluation Tests for Consideration
3. ISO-10993-5:2009 - Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
4. ISO-10993-10:2013 - Biological evaluation of medical devices - Part 10: Tests for irritation and
skin sensitization
5. ISO-10993-11:2009 - Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
6. ISO-10993-3:2009 - Biological evaluation of medical devices - Part 3: Tests for genotoxicity,
carcinogenicity and reproductive toxicity
7. ISO-10993-6:2009 - Biological evaluation of medical devices - Part 6: Tests for local effects after
implantation
8. ASTM F2077 – 11 - Test Methods for Intervertebral Body Fusion Devices
9. ASTM F543 - Standard Specification and Test Methods for Metallic Medical Bone Screws
10. ASTM F382-99 - Standard Specification and Test Method for Metallic Bone Plates
11. ASTM F1717 - Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model
12. ASTM F1886/F1886M – Standard Test Method for Determining Integrity of Seals for Flexible
Packaging by Visual Inspection
13. AAMI/ANSI/ISO 11135 Standards: Sterilization of health care products - Ethylene oxide
14. ISO 11607: Packaging for terminally sterilized medical devices
15. ASTM D4728: Test Method for Random Vibration Testing of Shipping Containers
16. ASTM D5276: Test Method for Drop Test of Loaded Containers by Free Fall
17. ISO 11737-2: Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility
performed in the definition, validation and maintenance of a sterilization process
18. EN 556: Sterilization of medical devices - Requirements for medical devices to be designated
"STERILE" - Part 1: Requirements for terminally sterilized medical devices
19. ISO11135-1: Sterilization of health care products - Ethylene oxide - Part 1: Requirements for
development, validation and routine control of a sterilization process for medical devices.
20. ISO 10933-7: Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals

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21. ASTM F88/F88M: Standard Test Method for Seal Strength of Flexible Barrier Materials
22. ASTM F2475 – 05: Standard Guide for Biocompatibility Evaluation of Medical Device Packaging
Materials
23. ASTM F1980: Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices
24. ISO 10993-12: 2012 - Biological evaluation of medical devices - Part 12: Sample preparation and
reference materials

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