Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis.
Collagen disorders, and/or avascular necrosis of the femoral condyle.
Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy.
Moderate valgus, varus, or flexion deformities.
The salvage of previously failed surgical attempts or for a knee in which satisfactory stability in flexion cannot be obtained at the time of surgery.

CR, LPS and CR-Flex porous coated femoral or tibial baseplate components may be used cemented or uncemented (biological fixation). All other femoral, tibial baseplate and allpolyethylene patella components (including HA/TCP coated) are indicated for cemented use only.

Device Description

This submission is for the uncemented use of NexGen porous total knee prostheses. All have already been cleared for cemented use.
Porous NexGen Cruciate Retaining (CR) Femoral Components
Porous NexGen CR 4-pegged Tibial Baseplate Components
Porous NexGen Stemmed Tibial Baseplate -Components
Porous NexGen CR-Flex Femoral -Components
Porous NexGen Legacy Posterior Stabilized (LPS) Femoral Components

Each of the above devices is part of a semiconstrained, non-linked condylar knee system. The CR devices are for use with a functional posterior cruciate ligament and the LPS device is for use with both cruciate ligaments excised.

These devices are identical to the predicate devices except for the uncemented indication for use.

AI/ML Overview

The provided document is a 510(k) summary for the Zimmer NexGen® Porous, Uncemented Femoral and Tibial Baseplate Components. This submission focuses on the uncemented use of these knee prostheses, which had previously been cleared for cemented use.

No studies were conducted to prove the device meets acceptance criteria. The document explicitly states:

Non-Clinical Performance and Conclusions: "No additional testing was required."
Clinical Performance and Conclusions: "Clinical data and conclusions were not needed for this device."

The basis for clearance is substantial equivalence to predicate devices already on the market for cemented use. The device is identical to the predicate devices except for the uncemented indication for use. Therefore, no new acceptance criteria based on performance studies are described or met within this document.

Since no performance studies were conducted, the following information is not available in this document:

Table of acceptance criteria and reported device performance: Not applicable as no new performance data was generated.
Sample size used for the test set and the data provenance: Not applicable.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
Adjudication method for the test set: Not applicable.
Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable.
Standalone (i.e., algorithm only without human-in-the-loop performance) study: Not applicable.
Type of ground truth used: Not applicable.
Sample size for the training set: Not applicable.
How the ground truth for the training set was established: Not applicable.

Summary

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

OCT - 9 2003

长 031061

p.1/2

Summary of Safety and Effectiveness

Submitter:	Zimmer, Inc.P.O. Box 708Warsaw, IN 46581-0708
Contact Person:	Stephen H. McKelveyManager, Regulatory AffairsTelephone: (574) 372-4944Fax: (574) 372-4605
Date:	June 30, 2003
Trade Name:	NexGen ® Porous, Uncemented Femoral and TibialBaseplate Components
Common Name:	Total Knee Prosthesis
Classification Nameand Reference:	Knee joint patellofemorotibial metal/polymerporous-coated uncemented prosthesis - 21 CFR §888.3565
Predicate Devices:	NexGen Complete Knee Solution, manufactured byZimmer, K933785, cleared January 30, 1995.
	NexGen Complete Knee Solution Cruciate RetainingFlex Femoral Component, manufactured byZimmer, K023211, cleared October 17, 2002.
	NexGen Complete Knee Solution Legacy PosteriorStabilized (PS) and Constrained Condylar Knee(CCK) Femoral Components and Articular Surfaces,manufactured by Zimmer, K960279, cleared April26, 1996.
Device Description:	This submission is for the uncemented use ofNexGen porous total knee prostheses. All havealready been cleared for cemented use.
	Porous NexGen Cruciate Retaining (CR)Femoral ComponentsPorous NexGen CR 4-pegged Tibial BaseplateComponents

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

Image /page/1/Picture/0 description: The image contains a sequence of alphanumeric characters. The characters are 'K', '0', '3', '1', '0', '6', and '1'. The characters are written in a simple, handwritten style.

P.2/2

Porous NexGen Stemmed Tibial Baseplate -Components
Porous NexGen CR-Flex Femoral -Components
Porous NexGen Legacy® Posterior Stabilized ﯩﺮ (LPS) Femoral Components

These devices are indicated for patients with severe knee pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, and/or avascular necrosis of the femoral condyle, post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy, and moderate valgus, varus, or flexion deformities. The salvage of previously failed surgical attempts or for a knee in which satisfactory stability in flexion cannot be obtained at the time of surgery.

CR, LPS and CR-Flex porous coated femoral or tibial baseplate components may be used cemented or uncemented (biological fixation). All other femoral, tibial baseplate and all-polyethylene patella components (including HA/TCP coated) are indicated for cemented use only

These devices are identical to the predicate devices except for the uncemented indication for use.

Non-Clinical Performance and Conclusions:

No additional testing was required.

Clinical Performance and Conclusions:

Clinical data and conclusions were not needed for this device.

Intended Use:

Comparison to Predicate Device:

Performance Data (Nonclinical and/or Clinical):

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

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 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" around the perimeter. Inside the circle is an abstract image of an eagle or bird-like figure with three stylized lines representing its wings or body.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K031061

Trade/Device Name: NexGen® Porous, Uncemented Femoral and Tibial Baseplate Components Regulation Number: 21 CFR 888.3565 Regulation Name: Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis Regulatory Class: II Product Code: MBH Dated: July 16, 2003 Received: July 17, 2003

OCT - 9 2003

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.

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

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 marketed predicate 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), please contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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,

b. Mark N. Millenson

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

{4}------------------------------------------------

Indications for Use

Page 1 of 1

K031061 510(k) Number (if known):

Device Name:

NexGen® Porous, Uncemented Femoral and Tibial Baseplate Components

Indications for Use:

This device is indicated for patients with severe knee pain and disability due to:

Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis. 】
Collagen disorders, and/or avascular necrosis of the femoral condyle. .
Post-traumatic loss of joint configuration, particularly when there is patellofemoral ー erosion, dysfunction or prior patellectomy.
Moderate valgus, varus, or flexion deformities. ·
The salvage of previously failed surgical attempts or for a knee in which satisfactory stability in flexion cannot be obtained at the time of surgery.

(Please do not write below this line - Continue on another page if nooded)

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)

for Mula N. Millen
(Division Sig

. Restorative ovices

510(k) Number_

000012

Regulation Number and Section

§ 888.3565 Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis.

(a)
Identification. A knee joint patellofemorotibial metal/polymer porous-coated uncemented 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 is designed to achieve biological fixation to bone without the use of bone cement. This identification includes fixed-bearing knee prostheses where the ultra high molecular weight polyethylene tibial bearing is rigidly secured to the metal tibial base plate.(b)
Classification. Class II (special controls). The special control is FDA's guidance: “Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses; Guidance for Industry and FDA.” See § 888.1 for the availability of this guidance.