DURACON CONVERSION METAL BACKED PATELLA

K972752 · Howmedica Corp. · JWH · Oct 21, 1997 · Orthopedic

Device Facts

• Record ID: K972752
• Device Name: DURACON CONVERSION METAL BACKED PATELLA
• Applicant: Howmedica Corp.
• Product Code: JWH · Orthopedic
• Decision Date: Oct 21, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3560
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Duracon® Conversion Metal Backed Patella is intended to be used with Duracon® femoral and tibial components as part of a total knee system. This total knee system is intended to be used to relieve pain and instability of the knee joint as a result of non-inflammatory joint disease, inflammatory joint disease, trauma, or failed previous prosthesis. Specifically, this patellar component is intended to replace the articular surface of the natural patella in primary or revision total knee scenarios. The Duracon® Conversion Metal Backed Patella is intended to be a revisable The patellar component will be made available with the polyethylene component. insert assembled to the metal backing. Separate polyethylene patellar inserts will be made available so the physician can intraoperatively replace excessively worn polyethylene to a well-fixed metal patellar baseplate. The Duracon® Conversion Metal Backed Patella is intended to be implanted using bone cement.

Device Story

Duracon® Conversion Metal Backed Patella is a modular orthopedic implant for total knee arthroplasty; consists of a metal baseplate and interchangeable polyethylene inserts. Designed for use with Duracon® femoral and tibial components; implanted via bone cement. Allows surgeons to intraoperatively replace worn polyethylene inserts while retaining a well-fixed metal baseplate. Used by orthopedic surgeons in clinical settings for primary or revision knee surgery to address joint pain and instability. Benefits patients by facilitating revision of the articular surface without requiring removal of the entire patellar component.

Clinical Evidence

Bench testing only. No clinical data presented.

Technological Characteristics

Modular patellar component consisting of a metal baseplate and polyethylene insert. Designed for cemented fixation. Intended for use as part of the Duracon® total knee system.

Indications for Use

Indicated for patients requiring total knee arthroplasty to relieve pain and instability due to non-inflammatory joint disease, inflammatory joint disease, trauma, or failed previous prosthesis. Used in primary or revision scenarios to replace the natural patellar articular surface. Must be implanted using bone cement.

Regulatory Classification

Identification

A knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a knee joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components and a retropatellar resurfacing component made of ultra-high molecular weight polyethylene. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).

Predicate Devices

• Duracon® Metal Backed Patella - Howmedica
• Duracon® All Polyethylene Patella - Howmedica
• PCA Modular Knee Tibial Baseplates and Tibial Inserts - Howmedica
• Series 7000 Metal Backed Patella - Osteonics

Submission Summary (Full Text)

{0}------------------------------------------------

K972752
510(k) Summary

## Duracon® Conversion Metal Backed Patella Device:

The Duracon® Conversion Metal Backed Patella is intended to be used with Duracon® femoral and tibial components as part of a total knee system. This total knee system is intended to be used to relieve pain and instability of the knee joint as a result of non-inflammatory joint disease, inflammatory joint disease, trauma, or failed previous prosthesis. Specifically, this patellar component is intended to replace the articular surface of the natural patella in primary or revision total knee scenarios.

The Duracon® Conversion Metal Backed Patella is intended to be a revisable The patellar component will be made available with the polyethylene component. insert and the metal backing. Separate polyethylene patellar inserts will be made available so the physician can intraoperatively replace polyethylene to a well-fixed metal patellar baseplate.

The Duracon® Conversion Metal Backed Patella is intended to be implanted using bone cement.

The Duracon® Conversion Metal Backed Patella is substantially equivalent to other legally marketed devices. These products include: Duracon® Metal Backed Patella -Howmedica; Duracon® All Polyethylene Patella - Howmedica; PCA Modular Knee Tibial Baseplates and Tibial Inserts -Howmedica; and Series 7000 Metal Backed Patella - Osteonics.

Testing was presented to address the FDA guidance document on Semi-Constrained Cemented Total Knee Prostheses.

| For information contact: | Margaret F. Crowe<br>Manager, Regulatory Affairs<br>Howmedica Inc.<br>359 Veterans Boulevard<br>Rutherford, NJ 07070 |
|--------------------------|----------------------------------------------------------------------------------------------------------------------|
| Telephone: | [phone] |
| Fax: | [phone] |

{1}------------------------------------------------

Image /page/1/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle or bird with outstretched wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird image.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

. . . . . . .

OCT 2 1 1997

Ms. Margaret F. Crowe Group Manager, Requlatory Affairs Howmedica Inc. Pfizer Hospital Products Group 359 Veterans Boulevard Rutherford, New Jersey 07070-2584

K972752 Re: Duracon® Conversion Metal Backed Patella Regulatory Class: II Product Code: JWH Dated: July 21, 1997 Received: July 23, 1997

Dear Ms. Crowe:

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). This decision is based on this device being equivalent only to similar devices labeled and intended to be fixed within bone with acrylic "bone and antenay, therefore, market your device subject to the general controls provisions of the Act and the following limitations:

- This device may not be labeled or promoted for non-1. cemented use. …………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………
- All labeling for this device, including package label 2. and labeling included within the package, must prominently state that the device is intended for cemented use only.
- Any non-cemented fixation of this device is considered 3 . investigational and may only be investigated as a significant risk device in accordance with the investigational device exemption (IDE) regulation under 21 CFR, Part 812. "All users of the device for noncemented fixation must receive approval from their respective institutional review boards (IRBs) and the Food and Drug Administration (FDA) to conduct the investigation.

The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practices, labeling, and prohibitions against misbranding and adulteration.

{2}------------------------------------------------

Page 2 - Ms. Margaret F. Crowe

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 requlations 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 Regulation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation 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.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification immediately. An FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and 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

{3}------------------------------------------------

Indications for Use

## 510(k) Number (if known):

Device Name: Duracon® Conversion Metal Backed Patella

Indications for Use:

The Duracon® Conversion Metal Backed Patella is intended to be used with Duracon® femoral and tibial components as part of a total knee system. This total knee system is intended to be used to relieve pain and instability of the knee joint as a result of non-inflammatory joint disease, inflammatory joint disease, trauma, or failed previous prosthesis. Specifically, this patellar component is intended to replace the articular surface of the natural patella in primary or revision total knee scenarios.

The Duracon® Conversion Metal Backed Patella is intended to be a revisable The patellar component will be made available with the polyethylene component. insert assembled to the metal backing. Separate polyethylene patellar inserts will be made available so the physician can intraoperatively replace excessively worn polyethylene to a well-fixed metal patellar baseplate.

The Duracon® Conversion Metal Backed Patella is intended to be implanted using bone cement.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use X (Per 21 CFR 801.109)

OR

Over-The-Counter Use

(Optional Format 1-2-96)

Division of General Re