OSTEO AUSTIN MOORE ENDOPROSTHESIS SYSTEM

K974807 · Osteonics Corp. · KWL · Mar 16, 1998 · Orthopedic

Device Facts

• Record ID: K974807
• Device Name: OSTEO AUSTIN MOORE ENDOPROSTHESIS SYSTEM
• Applicant: Osteonics Corp.
• Product Code: KWL · Orthopedic
• Decision Date: Mar 16, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3360
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Osteo Austin Moore Endoprosthesis System is a one-piece, hemi-hip replacement component. It is intended for cemented use only.

Device Story

The Osteo Austin Moore Endoprosthesis System is a metallic, one-piece hemi-hip replacement prosthesis. It features a fixed-head design for articulation with the natural acetabulum and includes fenestrations to facilitate cement interdigitation. The device is intended for cemented use only in patients undergoing hemi-hip replacement procedures. It is implanted by a surgeon to replace the femoral head and neck. The device provides a structural replacement for the damaged femoral component, aiming to restore hip function and alleviate pain associated with fractures, necrosis, or arthritis. It is designed to withstand in-vivo loading conditions.

Clinical Evidence

Bench testing only. The device successfully endured 10 million cycles of physiologically relevant loading to ensure it can withstand anticipated in-vivo conditions.

Technological Characteristics

One-piece hemi-hip femoral prosthesis; material: cobalt chromium alloy; design: classic Austin-Moore fixed-head with fenestrations for cement interdigitation; intended for cemented use only.

Indications for Use

Indicated for patients requiring hemi-hip replacement due to femoral head/neck fractures, aseptic necrosis of the femoral head, or osteo-, rheumatoid, and post-traumatic arthritis of the hip with minimal acetabular involvement.

Regulatory Classification

Identification

A hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis is a device intended to be implanted to replace a portion of the hip joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum. This generic type of device includes designs which are intended to be fixed to the bone with bone cement (§ 888.3027) as well as designs which have large window-like holes in the stem of the device and which are intended for use without bone cement. However, in these latter designs, fixation of the device is not achieved by means of bone ingrowth.

Predicate Devices

• Howmedica Austin Moore Endoprosthesis

Submission Summary (Full Text)

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# MAR 1 6 1998

510(k) Summary

## 510(k) Summary Osteo Austin Moore Endoprosthesis System

## Submission Information

Name and Address of the Sponsor:

Osteonics Corporation 59 Route 17 Allendale, NJ 07401-1677

Regulatory Affairs Specialist

Name and Address of the Manufacturer:

Osteo AG Bohnackerweg 1 CH-2545 Selzach Switzerland

Terry Sheridan

December 22, 1997

Contact Person:

Date of Summary Preparation:

Device Identification

Proprietary Name:

Common Name:

Predicate Device Identification

Classification Name and Reference:

Osteo Austin Moore Endoprosthesis System

Artificial hemi-hip stem

888.3360:Hip joint femoral(hemi-hip) metallic cemented or uncemented prosthesis

Howmedica Austin Moore Endoprosthesis, Howmedica Inc.

## Device Description

The Osteo Austin Moore Endoprosthesis System comes in a range of sizes to address variations in patient anatomy, and is intended for hemi-hip replacement procedures. It is intended to articulate with the natural acetabulum, and is intended for cemented use only.

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## Intended Use:

The Osteo Austin Moore Endoprosthesis System is a one-piece, hemi-hip replacement component. It is intended for cemented use only.

### Indications

- Femoral head/neck fractures .
- Aseptic necrosis of the femoral head .
- Osteo-, rheumatoid, and post-traumatic arthitis of the hip with minimal acetabular . involvement.

### Statement of Technological Comparison:

The substantial equivalence of the Osteo Austin Moore Endoprosthesis System is supported by a comparison of the subject device to the above-cited predicate devices with regard to intended use, materials, and design.

#### Intended Use

Both the subject devices and the predicate devices are intended for hemi-hip replacement for the specified indications, and are intended for cemented use.

## Materials

The subject devices and predicate devices are both cast from cobalt chromium alloy.

#### Design

The subject and predicate devices both feature the classic Austin-Moore design. This design includes a fixed-head for articulation with the acetabulum, and fenestrations for cement interdigitation.

#### Performance Data:

The Osteo Austin Moore Endoprosthesis System has been tested to ensure that the subject devices can withstand anticipated in-vivo loading conditions. All specimens successfully endured 10 million cycles of physiologically relevant loading.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 6 1998

Robert A. Koch, J.D. Director, Requlatory Affairs Osteonics Corporation 59 Route 17 Allendale, New Jersey 07401-1677

K974807 Re: Osteo Austin Moore Endoprosthesis System Trade Name: Regulatory Class: II Product Code: KWL December 22, 1997 Dated: December 23, 1997 Received:

Dear Mr. Koch:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include reguirements 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with ...... the current Good Manufacturing Practice requirement, as set forth in the Quality System Requlation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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## Page 2 - Robert A. Koch, J.D.

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): K 9 7 4 & 2 7

Device Name: Osteo Austin Moore Endoprosthesis System

## Indications For Use:

The subject devices are intended for hemi-hip replacement. They are intended for cemented use only.

## Indications

- Femoral head/neck fractures .
- Aseptic necrosis of the femoral head .
- Osteo-, rheumatoid, and post-traumatic arthitis of the hip with minimal acetabular involvement. .

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter Use

(Optional Format 1-2-96)

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