Cotton and Evans Wedges:
Opening wedge osteotomics of the bones of the foot including osteotomics for Hallux Valgus
Opening wedge of Medial Cunciform or Cotton osteotomies
Lateral Column Lengthening (Evans Lengthening Osteotomy or Calcancal Z Osteotomy)
Metatarsal/Cunciform arthrodesis
Midfoot Wedges
Opening wedge osteotomics of the bones of the foot including osteotomies for Hallux Valgus
Nonunion of arthrodesis of the Midfoot including Metatarsal/Cunciform arthrodesis (TMT or Lapidus)
This device is intended for use with ancillary fixation. The BIOFOAM® Bone Wedge is not intended for use in the spine.

Device Description

The BIOFOAM® Bone Wedge is a titanium metal foam wedge used for angular correction of small bones of the foot. It is offered with varying widths and thicknesses to accommodate a variety of small bone applications.

AI/ML Overview

The provided text describes the 510(k) summary for the WMT BIOFOAM® Bone Wedge. It focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study proving performance against acceptance criteria in the context of AI/ML device testing.

Therefore, many of the requested categories related to AI/ML device studies (such as sample size for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment for AI models) are not applicable to this submission.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Substantial Equivalence (Non-Clinical)	A testing rationale related to compression and fatigue testing was provided to support the equivalence of the subject device.
Material Identity	The subject and predicate devices are identical in material.
Safety and Effectiveness	The safety and effectiveness of the BIOFOAM® Bone Wedge is adequately supported by the testing rationale, substantial equivalence information, materials information, and comparison of design characteristics.
No New Worst-Case Devices Introduced	The testing rationale confirmed that no new worst-case devices are introduced in this system.
No New Questions of Safety or Effectiveness	The design characteristics of the subject system do not raise any new types of questions of safety or effectiveness.
Performance "at least as well as predicate"	From the evidence submitted, the subject devices can be expected to perform at least as well as the predicate device.

2. Sample Size Used for the Test Set and Data Provenance

Not applicable. This submission relies on non-clinical engineering testing (compression and fatigue testing) and comparison to a predicate device, not a test set of data in the AI/ML sense. No specific "sample size" of clinical cases or data is mentioned. Data provenance is therefore not relevant.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Not applicable. There was no expert-established ground truth for a test set in the context of an AI/ML device. The evaluation was based on engineering principles and comparison to a predicate.

4. Adjudication Method

Not applicable. No adjudication method was mentioned as it was not a clinical study involving human interpretation.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. An MRMC study was not done. This is a medical device (bone wedge), not an AI/ML diagnostic or assistive tool for human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this submission is based on:
- Engineering specifications and test standards: for compression and fatigue performance.
- Material properties: showing identity to the predicate device.
- Design characteristics comparison: ensuring no new safety or effectiveness concerns.

8. The Sample Size for the Training Set

Not applicable. There was no training set, as this is not an AI/ML device.

9. How the Ground Truth for the Training Set Was Established

Not applicable. There was no training set.

Summary

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111. 0 9 2014

Headquarters

K140531 Page 1 of 2

Wright Medical Technology, Inc 1073 Cham 9030

Memphis TN 38113

901 867 497 vint.com

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 WMT BIOFOAM® Bone Wedge.

(a)(1). Submitted By:

Wright Medical Technology, Inc. 1023 Cherry Road Memphis, TN 38117

Regulatory Affairs Specialist I Office - (901) 290-5162 Fax - (901) 867-4190

BIOFOAM® Bone Wedge

21 CFR 888.3030 - Class II

May 29, 2014

Val Myles

Bone Wedge

HRS, HWC

Date:

Contact Person:

(a)(2). Proprietary Name:

Common Name:

Classification Name and Reference:

Device Product Code, Device Panel:

(a)(3). Predicate Device:
K093950: BIOFOAM® Bone Wedge

(a)(4). Device Description

(a)(5). INTENDED USE

The indications for use for the subject devices convey the same overall intended use as the predicate device and were only modified to provide additional clarification, such as examples of use or the area of the foot in which the device can be used.

The BIOFOAM "Bone Wedge is intended to be used for internal bone fixation for bone fractures, fusions, or osteotomies in the ankle and foot, such as:

· Cotton and Evans Wedges:
- · Opening wedge osteotomies of the bones of the foot including osteotomies for Hallux Valgus
- · Opening wedge of Medial Cuneiform or Cotton osteotomies

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· Lateral Column Lengthening (Evans Lengthening Osteotomy or Calcaneal Z Osteotomy)
· Metatarsal/Cuneiform arthrodesis

• Midfoot Wedges:

· Opening wedge osteotomies of the bones of the foot including osteotomies for Hallux Valgus
· Nonunion of arthrodesis of the Midfoot including Metatarsal/Cuneiform arthrodesis (TMT or Lapidus)

This device is intended for use with ancillary fixation. The BIOFOAM Bone Wedge is not intended for use in the spine.

(a)(6). Technological Characteristics Comparison

The BIOFOAM® Bone Wedge is technologically substantially equivalent to the predicate device. The subject devices include the addition of the midfoot wedge design and larger cotton wedge sizes. The subject and predicate devices are identical in material.

(b)(1). Substantial Equivalence - Non-Clinical Evidence

A testing rationale related to compression and fatigue testing was provided to support the equivalence of the subject device and shows that no new worst-case devices are introduced in this system. The safety and effectiveness of the BIOFOAM® Bone Wedge is adequately supported by the testing rationale, substantial equivalence information, materials information and comparison of design characteristics provided within this premarket notification.

(b)(2). Substantial Equivalence - Clinical Evidence

N/A

(b){3). Substantial Equivalence — Conclusions

The design characteristics of the subject system do not raise any new types of questions of safety or effectiveness. From the evidence submitted in this 510(k), the subject devices can be expected to perform at least as well as the predicate device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

July 9, 2014

Wright Medical Technology, Incorporated Ms. Val Myles Regulatory Affairs Specialist I 1023 Cherry Road Memphis, Tennessee 38117

Re: K140531

Trade/Device Name: BIOFOAM® Bone Wedge Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: HRS, HWC Dated: June 4, 2014 Received: June 5, 2014

Dear Ms. Myles:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing

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Page 2 - Ms. Val Myles

(21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely vours.

Lori A. Wiqqins

for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.

510{k} Number (if known) K140531

Device Name BIOFOAM® Bone Wedge

Indications for Use (Describe)

The BIOFOAM® Bone Wedge is internal bone fixation for bone fractures, fusions, or osectornies in the ankle and foot, such as:

· Cotton and Evans Wedges:
- Opening wedge osteotomics of the bones of the foot including osteotomics for Hallux Valgus
- · Opening wedge of Medial Cunciform or Cotton osteotomies
- · Lateral Column Lengthening (Evans Lengthening Osteotomy or Calcancal Z Osteotomy)
- Metatarsal/Cunciform arthrodesis
· Midfoot Wedges
- · Opening wedge osteotomics of the bones of the foot including osteotomies for Hallux Valgus
- · Nonunion of arthrodesis of the Midfoot including Metatarsal/Cunciform arthrodesis (TMT or Lapidus)

This device is intended for use with ancillary fixation. The BIOFOAM® Bone Wedge is not intended for use in the spine.

Type of Use (Select one or both, as applicable)

[x] Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signalure)

Elizabeth La Frank -S

, Division of Orthopedic Devices

Regulation Number and Section

§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.

(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.