· Opening wedge osteotomies of Hallux Valgus
· Evans lengthening osteotomies
· Metatarsal/cuneiform arthrodesis.
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 in the ankle and foot. It is offered in one distinct design with varying widths and thicknesses to accommodate a variety of small bone applications.

AI/ML Overview

The provided text describes a 510(k) submission for the BIOFOAM™ Bone Wedge, and it does not contain the information requested in your prompt regarding acceptance criteria and a study proving the device meets those criteria.

This document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a previously cleared device, rather than detailed performance study results against specific acceptance criteria.

Here's why the prompt's requested information cannot be extracted from the provided text:

Acceptance Criteria & Reported Performance: The document states, "The safety and effectiveness of the BIOFOAM™ Bone Wedge is adequately supported by the substantial equivalence information, materials information, and analysis data provided within this Premarket Notification." It does not provide a table of pre-defined acceptance criteria or specific performance metrics.
Sample Size (Test Set) & Data Provenance: This information is typically found in a detailed clinical or non-clinical study report, which is not part of this summary. The 510(k) relies on "materials information, and analysis data," implying bench testing, but no specifics are given.
Number of Experts, Qualifications, Adjudication Method: These points are relevant to studies involving expert review (e.g., image-based diagnostic devices). The BIOFOAM™ Bone Wedge is a physical implant, and its evaluation would not typically involve expert ground truth establishment in this manner.
MRMC Comparative Effectiveness Study: This type of study is for diagnostic devices where human readers interpret results, often with and without AI assistance. This is not applicable to a bone wedge implant.
Standalone Performance: While the "analysis data" mentioned likely includes standalone performance (e.g., mechanical testing), the specifics of how it was measured and against what thresholds are not provided in this summary.
Type of Ground Truth: For an implantable device, ground truth would usually refer to successful implantation, biocompatibility, mechanical integrity, and clinical outcomes. The document does not detail how this was established beyond "substantial equivalence."
Sample Size (Training Set) & Ground Truth (Training Set): These are relevant for AI/ML device development. This device is a physical implant, not an AI/ML algorithm, so these concepts do not apply in this context.

In summary, the provided document focuses on demonstrating substantial equivalence to a predicate device, which is the primary mechanism for 510(k) clearance. It does not include the detailed study design, acceptance criteria, and performance results that would be present in a comprehensive study report for a novel or more complex device.

Summary

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K073535 i of d

510(K) SUMMARY OF SAFETY AND EFFECTIVENESS JAN - 7 2008

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 CRF 807, this information serves as a Summary of Safety and Effectiveness for the BIOFOAM™ Bone Wedge.

Submitted By:	Wright Medical Technology, Inc.
Date:	November 19, 2007
Contact Person:	Brian Young
	Sr. Director, Regulatory Affairs
Proprietary Name:	BIOFOAM TM Bone Wedge
Common Name:	Bone Wedge
Classification Name and Reference:	21 CFR 888.3040/ HWC Smooth or threaded metallic bone fixation fastener - Class II
	21 CFR 888.3030/ HRS Single/multiple component metallic bone fixation appliances and accessories - Class II
Device Product Code and Panel Code:	Orthopedics/87/HWC & Orthopedics/87/HRS

DEVICE INFORMATION

A. INTENDED USE

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:

· Opening wedge osteotomies of Hallux Valgus
· Evans lengthening osteotomies
· Metatarsal/cuneiform arthrodesis

The BIOFOAM™ Bone Wedge is not intended for use in the spine.

B. DEVICE DESCRIPTION

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Ki735535 pg Rct 2

C. SUBSTANTIAL EQUIVALENCE INFORMATION

The design features, material, and indications for use of the BIOFOAM™ Bone Wedge are substantially equivalent to the previously 510(k) cleared Small Bone Wedge. The safety and effectiveness of the BIOFOAM™ Bone Wedge is adequately supported by the substantial equivalence information, materials information, and analysis data provided within this Premarket Notification.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" are arranged in a circle around the eagle. The logo is black and white.

Public Health Service

JAN - 7 2008

Food and Drug Administration 200 Corporate Boulevard Rockville MD 20850

Wright Medical Technologies, Inc. % Mr. Brian Young 5677 Airline Road Arlington, TN 38002

K073535 Re: 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: II Product Code: HRS, HWC Dated: November 19, 2007 Received: December 17, 2007

Dear Mr. Young:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Mr. Brian Young

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807,97). For questions regarding postmarket surveillance. please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark N. Mikkelson

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known):

Device Name: BIOFOAM™ Bone Wedge

Indications For Use:

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:

· Opening wedge osteotomies of Hallux Valgus
· Evans lengthening osteotomies
· Metatarsal/cuneiform arthrodesis.

The BIOFOAM™ Bone Wedge is not intended for use in the spine.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

1 of 1

Kourence A. Clay FOR M.MELKERSON

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

K073535 510(k) Number

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.