The Kinemax® Superstabilizer (K904208), Kinematic® II Modular Condylar and Stabilizer Inserts (K871349), PCA® Modular Inserts (K894403), Kinematio® Rotating Hinge Knee (K792089), Duracon® Unicompartmental Knee (K 926231), and the Modular Replacement Metal Encapsulated Components (K952970) are intended to be used with the PCA®, Duracon®, or Kinemax® family of femoral components, tibial baseplates, and patellar components in primary or revision cemented total knee arthroplasty.

Device Description

This submission describes additional UHMWPE Knee components that can be sterilized by the Duration® Stabilized process previously cleared in submission K936292, as an alternate to standard air irradiated gamma sterilization. Corresponding wear claims, previously cleared in submission K 965173 and listed below, are also applicable to these additional components. This submission includes the Kinemax® Superstabilizer (K904208), the Kinematic® II Modular Condylar and Stabilizer Inserts (K871349), the PCA Modular Inserts(K894403), the Kinematic® Rotating Hinge Knee (K792089), the Duracon® Unicompartmental Knee (K926231), and the Modular Replacement Metal Encapsulated Components (K952970). These components are intended to be used with the PCA®, Duracon®, or Kinemax® family of femoral components, tibial baseplates, and patellar components in primary or revision cemented total knee arthroplasty.

AI/ML Overview

This 510(k) summary describes the Duraction® Stabilized UHMWPE Knee Components and their wear claims. The submission details three in vitro wear tests comparing the Duraction® Stabilized UHMWPE with conventionally gamma sterilized UHMWPE.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied)	Reported Device Performance (Reduction in Volumetric Wear)	Study Type	Articulating Counterface	Lubricant	Cycles (Duration)
Significant Reduction in Volumetric Wear (vs. conventionally sterilized)	30% reduction	Ring-on-Block	CoCr circular disk	Bovine calf serum	Over 5 million cycles
Significant Reduction in Volumetric Wear (vs. conventionally sterilized)	68% reduction	Pin-on-Disk	CoCr cylindrical pin (1" spherical end)	Bovine calf serum	Over 4 million cycles
Significant Reduction in Volumetric Wear after aging (vs. aged conventionally sterilized)	91% reduction	Pin-on-Disk (Aged)	CoCr cylindrical pin (1" spherical end)	Bovine calf serum	Over 2.5 million cycles (after 23 days simulated aging)

Note: The document does not explicitly state "acceptance criteria" but rather presents the results as "wear claims" based on the performed in vitro tests. The implied acceptance criterion for each test is a demonstrated reduction in volumetric wear compared to the conventionally gamma sterilized UHMWPE.

2. Sample Size Used for the Test Set and Data Provenance

The document describes material-level testing rather than patient or imaging data.

Sample Size:
- Ring-on-Block Test: "A block of Howmedica's Duration® Stabilized UHMWPE" and "the same block of Howmedica's conventionally gamma sterilized UHMWPE." (Implies n=1 for each material type for the block test, though likely multiple replicates were used within the block).
- Pin-on-Disk Tests (both non-aged and aged): "A 9mm thick circular disk of Howmedica's Duration® Stabilized UHMWPE" and "the same circular disk of Howmedica's conventionally gamma sterilized UHMWPE." (Implies n=1 for each material type for the disk test, though likely multiple replicates were used).
Data Provenance: The tests are described as "in vitro tests" and "independent laboratory test(s)." The country of origin of the data is not specified, but the manufacturer is Howmedica Inc. in the USA. The data is prospective for these specific tests as they were conducted to support the submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

Not applicable. This is a materials science engineering test, not a medical device performance assessment based on expert interpretation (e.g., radiology reads). The "ground truth" is measured volumetric wear.

4. Adjudication Method for the Test Set

Not applicable. This is a direct measurement of material wear, not a consensus-based assessment.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is an in vitro materials test, not a clinical study involving human readers or AI.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done

Not applicable. This refers to the performance of the UHMWPE material itself, not an algorithm.

7. The Type of Ground Truth Used

The ground truth used for these tests is measured volumetric wear of the material samples under controlled in vitro laboratory conditions.

8. The Sample Size for the Training Set

Not applicable. This is not a machine learning or AI device that requires a training set. The "training" in this context would refer to the development and optimization of the UHMWPE material and sterilization process, which is not detailed in terms of sample sizes for individual material property tests.

9. How the Ground Truth for the Training Set Was Established

Not applicable. (See point 8). The "ground truth" for material development would involve various material characterization techniques and performance testing during the R&D phase, but this specific 510(k) focuses on the final wear claims derived from the described in vitro tests.

Summary

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K97 2863

510(k) Summary

Proprietary Name: Duration® Stabilized UHMWPE Knee Components

Common Name: UHMWPE Knee Components

OCT 29 1997

21 CFR 888.3560 Classification Name and Reference:

Proposed Requiatory Class: Class II Device Product Code: JWH

For information contact: Frank Maas Manager, Regulatory Affairs Howmedica Inc. 359 Veterans Boulevard Rutherford, NJ 07070 Telephone: (201) 507-7875 (201) 507-6870 Fax: Date Summary Prepared: 8-1-97

This submission includes the Kinemax® Superstabilizer (K904208), the Kinematic® II Modular Condylar and Stabilizer Inserts (K871349), the PCA Modular Inserts(K894403), the Kinematic® Rotating Hinge Knee (K792089), the Duracon® Unicompartmental Knee (K926231), and the Modular Replacement Metal Encapsulated Components (K952970). These components are intended to be used with the PCA®, Duracon®, or Kinemax® family of femoral components, tibial baseplates, and patellar components in primary or revision cemented total knee arthroplasty.

Following are the wear claims that will be made for these devices:

A block of Howmedica's Duration® Stabilized UHMWPE showed a 30% reduction in volumetric wear versus the same block of Howmedica's conventionally gamma sterilized UHMWPE. Testing was performed in a reciprocating ring-on-block wear test for over 5 million cycles, using a circular disk, 2.83" in diameter, 1" wide, CoCr articulating counterface and bovine calf serum as a lubricant. The results of in vitro tests have not been shown to correlate with clinical wear mechanisms.

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In an independent laboratory test, a 9mm thick circular disk of Howmedica's Duration® Stabilized UHMWPE showed a 68% reduction in volumetric wear versus the same circular disk of Howmedica's conventionally gamma sterilized UHMWPE. Testing was performed in a reciprocating pin-on-disk wear evaluation over 4 million cycles, using a CoCr cylindrical pin with a 1" spherical end as the articulating counterface and bovine calf serum as a lubricant. The results of in vitro tests have not been shown to correlate with clinical wear mechanisms.

In an independent laboratory test, a 9 mm thick circular disk of Howmedica's Duration® Stabilized UHMWPE, having undergone 23 days of heating in air to simulate 7-9 years of "aging", showed a 91% reduction in volumetric wear versus the same circular disk of Howmedica's conventionally gamma sterilized UHMWPE, having undergone 23 days of heating in air to simulate 7-9 years of "aging". Testing was performed in a reciprocating pin-on-disk wear evaluations over 2.5 million cycles, using a CoCr cylindrical pin with a 1" spherical end as the articulating counterface and bovine calf serum as a lubricant. The results of in vitro tests have not been shown to correlate with clinical wear mechanisms.

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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 and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Frank Maas Requlatory Affairs Manager Howmedica, Inc. Pfizer Hospital Products Group 359 Veterans Boulevard Rutherford, New Jersey 07070-2584

OCT 2 9 1997

K972863 Re: Duration® Stabilized UHMWPE Trade Name: Knee Components Requlatory Class: II Product Code: JWH Dated: August 1, 1997 Received: August 4, 1997

Dear Mr. Maas:

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 cement." You may, 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.

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Page 2 - Mr. Frank Maas

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.

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 Regulation (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 Requlations.

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

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Page 3 - Mr. Frank Maas

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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K972863

DURATION® WEAR CLAIMS - KNEE COMPONENTS

In an independent laboratory test, a 9 mm thick circular disk of Howmedica's Duration® Stabilized UHMWPE showed a 68% reduction in volumetric wear versus the same circular disk of Howmedica's conventionally gamma sterilized UHMWPE. Testing was performed in a reciprocating pin-on-disk wear evaluation over 4 million cycles, using a CoCr cylindrical pin with a 1" spherical end as the articulating counterface and bovine calf serum as a lubricant. The results of in vitro tests have not been shown to correlate with clinical wear mechanisms.

Prescription Use
(Per 21 CFR 801.109)

ACotter

Sign-Off of General Restorative (k) Number

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Indications for Use

K972863

510(k) Number (if known):

Device Name: Duration® Stabilized UHMWPE Knee Components

Indications for Use:

SEE NEXT PAGE FOR DURATION® WEAR CLAIMS

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use	X	OR	Over-The-Counter Use
(Per 21 CFR 801.109)

(Division Sign-Off)
Division of General Restorative Devices
(Optional Format 1-2-96)

510(k) Number	K972863
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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.