SMALL BONE WEDGE

K070592 · Wrightmedicaltechnologyinc · HRS · Oct 5, 2007 · Orthopedic

Device Facts

• Record ID: K070592
• Device Name: SMALL BONE WEDGE
• Applicant: Wrightmedicaltechnologyinc
• Product Code: HRS · Orthopedic
• Decision Date: Oct 5, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

Small Bone Wedge is a titanium metal foam implant designed for angular correction of small bones in the ankle and foot. Device is provided in multiple widths and thicknesses to accommodate specific anatomical requirements. Used by orthopedic surgeons during surgical procedures to stabilize bone fractures, fusions, or osteotomies. Implant provides structural support to maintain bone alignment during the healing process. Device is purely mechanical; no electronic or software components.

Clinical Evidence

No clinical data provided; substantial equivalence supported by design, material, and analysis data.

Technological Characteristics

Titanium metal foam; metallic bone fixation fastener/appliance; available in varying widths and thicknesses; non-electronic; mechanical fixation.

Indications for Use

Indicated for internal bone fixation in the ankle and foot for patients requiring fracture repair, fusion, or osteotomy (e.g., Hallux Valgus, Evans lengthening, metatarsal/cuneiform arthrodesis). Contraindicated for use in the spine.

Regulatory Classification

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.

Submission Summary (Full Text)

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K070592 pg 1 of 2

#### UCT 6 2007

### 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

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 use of the Small Bone Wedge.

| Submitted By: | Wright Medical Technology, Inc. |
|-------------------------------------|-------------------------------------------------------------------------------------------------------------|
| Date: | June 27, 2007 |
| Contact Person: | Brian Young |
| | Sr. Director, Regulatory Affairs |
| Proprietary Name: | Small Bone Wedge |
| Common Name: | 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

#### INDICATIONS

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

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### B. DEVICE DESCRIPTION

The Small Bone wedge is a titanium metal foam wedge used for angular correction of small bones in the ankle and foot. It is offered in two distinct designs with varying widths and thicknesses to accommodate a variety of small bone applications.

## C. SUBSTANTIAL EQUIVALENCE INFORMATION

The design features, material, and indications for use of the WMT Wedge are substantially equivalent to the predicate devices. The safety and effectiveness of the WMT 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 U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" arranged in a circular fashion around the symbol. The caduceus is depicted in black, and the text is also in black.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Wright Medical Technology, Inc. % Mr. Brian Young Senior Director, Regulatory Affairs 5677 Airline Road Arlington, TN 38002

OCT 5 " 2007

Re: K070592 Trade/Device Name: Small 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: June 25, 2007 Received: July 10, 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, isting 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 Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number [phone] or [phone] or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Barbara Barchum

Mark N. Melke 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

K 070592 510(k) Number (if known):

Device Name: Small Bone Wedge

Indications For Use:

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

Prescription Use (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)

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Barbara Vincent Arnon

eneral, Restorative, and Neurological Devices

510(k) Numb: k070592