KINEMATIC ALL-POLYETHYLENE PATELLA WITH THREE PEGS by HOWMEDICA CORP.

The Kinematio® All-Polyethylene Patella with Three Pegs is intended to be used with the femoral and tibial components of the Kinematic® and Kinematic® II total knee systems, and the distal femoral component of the Howmedica Modular Replacement System in primary and/or revision total knee arthroplasty. This component is intended to resurface the articular surface of the patella. It is intended to be implanted with bone cement.

Device Description

The Kinematic® All-Polyethylene Patella with Three Pegs is available in three sizes: small, medium, and large. This component has a rounded, dome articular surface that is intended to mate with the intercondylar recess of the above-referenced femoral components. The articular surface of the subject device is identical to the articular surface of the previously cleared Kinematio® Patella.

The undersurface design of the Kinematic® All Polyethylene Patella with Three Pegs has a triangular cement recess with three straight pegs. This undersurface design is identical to the Duracon® All Polyethylene Patella II undersurface. The existing Kinematio® Patella has a central keel with fixation holes. This undersurface is being modified to three pegs to allow common instrumentation to be used throughout Howmedica's total knee systems.

The Kinematic® All-Polyethylene Patella with Three Pegs is fabricated from Ultra-High Molecular Weight Polyethylene, which conforms to ASTM specification F-648. The Kinematio® All Polyethylene Patella with Three Pegs will be made available in two versions: one will be sterilized via a room air gamma sterilization method, and the second version will be sterilized via a gamma sterilization method in an inert environment followed by heat treatment.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device, the Kinematic® All-Polyethylene Patella with Three Pegs. This submission aims to demonstrate "substantial equivalence" to legally marketed predicate devices, rather than establishing specific acceptance criteria and proving performance through a clinical study with detailed metrics typically found for AI/ML devices or novel technologies.

Therefore, many of the requested sections regarding acceptance criteria, sample sizes, ground truth establishment, expert adjudication, and comparative effectiveness studies are not applicable to this type of regulatory submission (a 510(k) for a class II medical device like a knee implant from 1997). The focus is on demonstrating equivalence based on design, materials, intended use, and operational principles.

However, I can extract information related to the device description and the limited performance data presented to support the substantial equivalence claim.

Kinematic® All-Polyethylene Patella with Three Pegs Device Performance Summary

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied)	Reported Device Performance
Mechanical/Biomechanical Equivalence: - Similar design features - Similar materials - Similar operational principles	Design/Material Equivalence: - Articular surface identical to Kinematic® Patella. - Undersurface design (triangular cement recess with three pegs) identical to Duracon® All Polyethylene Patella II undersurface. - Fabricated from Ultra-High Molecular Weight Polyethylene (conforms to ASTM F-648). Functional Equivalence (Limited Testing): - Patello-femoral contact area testing presented. - Lateral subluxation testing of the patella presented. Intended Use Equivalence: - Intended for use with Kinematic® and Kinematic® II total knee systems, and Howmedica Modular Replacement System. - Intended to resurface the articular surface of the patella. - Intended to be implanted with bone cement.

Acceptance Criteria (Implied)

Reported Device Performance

Mechanical/Biomechanical Equivalence: - Similar design features - Similar materials - Similar operational principles

Design/Material Equivalence: - Articular surface identical to Kinematic® Patella. - Undersurface design (triangular cement recess with three pegs) identical to Duracon® All Polyethylene Patella II undersurface. - Fabricated from Ultra-High Molecular Weight Polyethylene (conforms to ASTM F-648). Functional Equivalence (Limited Testing): - Patello-femoral contact area testing presented. - Lateral subluxation testing of the patella presented. Intended Use Equivalence: - Intended for use with Kinematic® and Kinematic® II total knee systems, and Howmedica Modular Replacement System. - Intended to resurface the articular surface of the patella. - Intended to be implanted with bone cement.

2. Sample size used for the test set and the data provenance

Sample Size: Not explicitly stated. The text mentions "Patello-femoral contact area and lateral subluxation testing of the patella were presented," implying some form of mechanical or in-vitro testing. However, no number of samples (e.g., number of implants tested, or number of cadaveric knees used) is provided.
Data Provenance: Not specified. Given the nature of a 510(k) for an orthopedic implant, these tests would typically be laboratory-based (in-vitro) mechanical or biomechanical tests. There is no mention of human clinical data or geographical origin.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not Applicable. This type of information is pertinent to studies involving human data and expert judgment, such as image interpretation. For a device like a knee implant, performance is assessed through engineering specifications, material properties, and biomechanical testing, not typically through expert consensus on a "ground truth" test set in the same way an AI algorithm for diagnosis would be.

4. Adjudication method for the test set

Not Applicable. See point 3.

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 not an AI/ML device. The submission is for a physical medical implant.

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

Not Applicable. This is not an AI/ML device.

7. The type of ground truth used

The "ground truth" in this context would be defined by engineering specifications, biomechanical standards, and material properties (e.g., ASTM F-648 for UHMWPE). The testing for patello-femoral contact area and lateral subluxation would be compared against expected values or performance of the predicate devices. There is no "expert consensus" or "pathology" in the typical sense for this device.

8. The sample size for the training set

Not Applicable. This is not an AI/ML device and thus does not have a "training set."

9. How the ground truth for the training set was established

Not Applicable. See point 8.

Summary

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510(k) Summary

JUL - 8 1997

Kinematic® All-Polyethylene Patella with Three Pegs Device:

The Kinematic® All-Polyethylene Patella withThree Pegs is available in three sizes: small, medium, and large. This component has a rounded, dome articular surface that is intended to mate with the intercondylar recess of the above-referenced femoral components. The articular surface of the subject device is identical to the articular surface of the previously cleared Kinematio® Patella.

The Kinematic® All Polyethylene Patella with Three Pegs is substantially equivalent to other legally marketed Howmedica devices: 1) Kinematic® All Poly Patella and 2) Duracon® All Polyethylene Patella II. This substantial equivalence determination is based on similarities in design, materials, intended use and operational principles.

Patello-femoral contact area and lateral subluxation testing of the patella were presented.

Margaret F. Crowe For information contact:

Manager, Regulatory Affairs Howmedica Inc. 359 Veterans Boulevard Rutherford, NJ 07070 (201) 507-7431

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Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines forming its body and wings. The bird is oriented towards the right. Encircling the bird is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

JUL - 8 1997

K971550 Re : Kinematic All-Polyethylene Patella with 3 Pegs Requlatory Class: II Product Code: JWH Dated: April 25, 1997 Received: April 28, 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 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 1. non-cemented use.
All labeling for this device, including package label and 2. labeling included within the package, must prominently state that the device is intended for cemented use only.

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Page 2 - Ms. Margaret F. Crowe

Any non-cemented fixation of this device is considered 3. investigational and may only be investiqated as a siqnificant risk device in accordance with the investigational device exemption (IDE) requlation under 21 CFR, Part 812. All users of the device for non-cemented fixation must receive approval from their respective institutional review boards (IRBs) and the Food and Drug Administration (FDA) to conduct the investiqation.
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 Requlation (QS) for Medical Devices: General requlation (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 regulation may result in regulatory action. In addition, FDA may publish further announcements 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.

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Page 3 - Ms. Margaret F. Crowe

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 requlation 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,

[signature]

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): K971550

Kinematic® All-Polyethylene Patella with Three Pegs Device Name:

Indications for Use:

The Kinematio® All-Polyethylene Patella with Three Pegs is intended to be used with the femoral and tibial components of the Kinematic® and Kinematic® II total knee systems,

and the distal femoral component of the Howmedica Modular Replacement System in primary and/or revision total knee arthroplasty. This component is intended to resurface the articular surface of the patella. It is intended to be implanted with 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 (Per 21 CFR 801.109 Over-The-Counter Use

(Optional Format 1-2-96)

Format 1-2-96)

471556

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.