This device is intended to reduce or relieve pain and restore function and motion to the knee joint. Total knee replacement is indicated for patients with severe knee pain and disability due to rheumatoid arthritis, osteoarthritis, primary and secondary traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral condyle or pseudogout, posttraumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy, moderate valgus, varus, or flexion deformities. This device may also be indicated in the salvage of previously failed surgical attempts if the knee can be satisfactorily balanced and stabilized at the time of surgery. This device is intended to be used as part of a cemented knee system.

Device Description

These components are manufactured of machined Ultra-High Molecular-Weight (UHMWPE) polyethylene. Both the modified and predicate devices are crosslinked by exposure to electron-beam (e-beam) radiation.

Except for a minor modification to the patellar cutout, Prolong Highly Crosslinked Polyethylene Cruciate Retaining (CR) Articular Surface Components are identical to the predicate device. The modification does not change the intended use or the fundamental scientific technology. It is packaged and sterilized using the same materials and processes.

AI/ML Overview

The provided document is a 510(k) premarket notification for a medical device: the Prolong™ Highly Crosslinked Polyethylene Cruciate Retaining (CR) Articular Surface Component. This document is related to a joint replacement component, not an AI/ML-driven device. Therefore, the information requested about acceptance criteria, study details, ground truth, and expert involvement (which are typical for AI/ML device evaluations) are not applicable to this submission.

Here's a breakdown of why the requested information cannot be provided from this document:

Device Type: The device is a physical knee joint component made of Ultra-High Molecular-Weight (UHMWPE) polyethylene, crosslinked by electron-beam radiation.
Regulatory Pathway: This is a 510(k) submission, demonstrating substantial equivalence to a predicate device (NexGen® Complete Knee Solution Crosslinked Polyethylene Cruciate Retaining (CR) Articular Surface Component, K003910).
Performance Data: The document states, "Performance testing completed as part of the design assurance procedure demonstrated that this device is safe and effective and substantially equivalent to the predicate device." However, it does not provide details of this performance testing, acceptance criteria, or the specific results. The focus of the 510(k) summary is on comparing the new device to the predicate device and confirming the modification (minor change to the patellar cutout) does not alter intended use or fundamental scientific technology.

Therefore, I cannot populate the table or answer the specific questions related to AI/ML device evaluation criteria. The document simply confirms that performance testing was done and found the device substantially equivalent.

Summary

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12013991

DEC 2 7 2001

Summary of Safety and Effectiveness

Submitter:

Zimmer, Inc. P.O. Box 708 Warsaw, Indiana 46581-0708 (219) 267-6131

Stephen McKelvey Manager, Regulatory Affairs (219) 372-4944 (219) 372-4605

December 20, 2001

Prolong™ Highly Crosslinked Polyethylene Cruciate Retaining (CR) Articular Surface Component

Crosslinked Articular Surfaces

Knee joint patellofemorotibial polyethylene/ metal/ polyethylene semiconstrained cemented total knee prosthesis - 21 CFR 888.3560

The predicate device for the Prolong CR Articular Surface Component is the NexGen® Complete Knee Solution Crosslinked Polyethylene Cruciate Retaining (CR) Articular Surface Component, K003910, cleared March 19, 2001.

Contact Person:

Telephone: Fax:

Date:

Trade Name:

Common Name:

Classification Name and Reference

Predicate Devices:

Device Description:

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Intended Use:

Performance testing completed as part of the design assurance procedure demonstrated that this device is safe and effective and substantially equivalent to the predicate device.

Comparison to Predicate Devices:

Performance Data:

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Image /page/2/Picture/12 description: The image shows the logo for the U.S. Department of Health & 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 an abstract symbol resembling an eagle or bird in flight, composed of three stylized, curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 2 7 2001

Mr. Stephen H. McKelvey Manager, Regulatory Affairs Zimmer, Inc. P.O. Box 708 Warsaw, Indiana 46581-0708

Re: K013991

. Trade/Device Name: Prolong™ Highy Crosslinked Polyethylene Cruciate Retaining (CR) Articular Surface Component Regulation Number: 21 CFR 888.3560 Regulation Name: Knee Joint, Patellofemorotibial, Polymer/Metal/Polymer, Semi-Constrained, Cemented Prosthesis Regulatory Class: Class II Product Code: JWH Dated: December 3, 2001 Received: December 4, 2001

Dear Mr. McKelvey:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 – Mr. Stephen H. McKelvey

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally prematicated nodicate 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 21 CFR Part 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Sincerely yours,
Mark A. Milkenon

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

Enclosure

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Indications for Use

Page 1 of 1

510(k) Number (if known): K013991

Device Name:

Prolong Highly Crosslinked Polyethylene Cruciate Retaining (CR) Articular Surface Component

Indications for Use:

Prolong crosslinked polyethylene cruciate retaining articular surfaces are intended to be used as part of a cemented knee system.

(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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for Mark N Milburn

(Division Sign-On)

Division of Gastroenterology, Restorative

and Neurological Devices

510(k) Number	K013991
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000009

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.