DURACON CONVERSION METAL BACKED PATELLA by HOWMEDICA CORP.

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 Description

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.

AI/ML Overview

This document (K972752) is a 510(k) summary for a medical device called the Duracon® Conversion Metal Backed Patella, not a study report. Therefore, it does not contain information about acceptance criteria, device performance metrics, sample sizes, ground truth establishment, or clinical study results in the manner requested.

A 510(k) submission generally aims to demonstrate substantial equivalence to a legally marketed predicate device, rather than proving a device meets specific performance criteria through clinical studies. The "testing presented to address the FDA guidance document on Semi-Constrained Cemented Total Knee Prostheses" would refer to mechanical and/or bench testing, not clinical studies involving human subjects or AI algorithms.

Therefore, I cannot fulfill your request for the tables and details regarding acceptance criteria, study design, and performance metrics as they would typically be found in a clinical study report for an AI/ML powered device. This document describes a traditional medical device (a knee implant) and its regulatory pathway.

The relevant information from the provided text is that the device is "substantially equivalent to other legally marketed devices" and that "Testing was presented to address the FDA guidance document on Semi-Constrained Cemented Total Knee Prostheses." This indicates the device's equivalence was established through a comparison to existing devices and likely through non-clinical (e.g., mechanical) testing, not through the type of performance study you are asking about.

Summary

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K972752
510(k) Summary

Duracon® Conversion Metal Backed Patella Device:

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. CroweManager, Regulatory AffairsHowmedica Inc.359 Veterans BoulevardRutherford, NJ 07070
Telephone:	(201) 507-7431
Fax:	(201) 507-6870

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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.

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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 (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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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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 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)

Over-The-Counter Use

(Optional Format 1-2-96)

Division of General Re

Regulation Number and Section

§ 888.3560 Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.

(a)
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).(b)
Classification. Class II.