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

Device Description

The devices included in this 510(k), are identical to their predicates except for the addition of HA/TCP.

AI/ML Overview

This document describes a 510(k) premarket notification for the NexGen® Porous, HA/TCP, Uncemented Femoral and Tibial Baseplate Components.

Here's an analysis of the provided information regarding acceptance criteria and the study that proves the device meets them:

1. A table of acceptance criteria and the reported device performance

The document does not provide a table of acceptance criteria or specific reported device performance metrics in the way one would expect for a diagnostic AI device. This is because the submission is for a medical implant (total knee prosthesis components), not a diagnostic AI device. The regulatory pathway for this type of device relies on demonstrating substantial equivalence to a predicate device rather than meeting specific performance criteria against a ground truth.

The "performance" in this context is implicitly the expected mechanical and biological performance of the implant, which is deemed acceptable if it's "substantially equivalent" to an already cleared predicate device.

Table of Comparison (derived from the text):

Feature/Criteria	Predicate Device: NexGen® Porous, Uncemented Femoral and Tibial Baseplate Components (K031061)	Current Device: NexGen® Porous, HA/TCP, Uncemented Femoral and Tibial Baseplate Components	Acceptance Status
Device Description	Not explicitly stated, but assumed to be porous-coated uncemented femoral and tibial baseplate components.	Identical to predicates except for the addition of HA/TCP.	Met (Addition of HA/TCP is the key difference)
Intended Use	Not explicitly stated for predicate, but assumed to be for total knee prosthesis as described in K031061.	Identical indications for use as described in the summary.	Met (Same intended use)
Non-Clinical Performance	Met requirements for K031061.	No additional testing was required.	Met (Based on similarity, no new non-clinical data needed)
Clinical Performance	Met requirements for K031061.	Clinical data and conclusions were not needed for this device.	Met (Based on similarity, no new clinical data needed)

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

There was no separate "test set" or study in the traditional sense for evaluating new performance data. The device was deemed substantially equivalent based on its physical similarity to a predicate device and the addition of a well-understood material (HA/TCP). Therefore, information like sample size, data provenance, retrospective/prospective nature, or country of origin is not applicable to this 510(k) submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. As there was no specific "test set" and no new performance data generated for this substantial equivalence submission, there was no need for experts to establish ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. No test set or independent adjudication was performed as part of this submission. The "adjudication" was effectively the FDA's review of the submission and comparison to the predicate device.

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 device is a total knee prosthesis component, not an AI-powered diagnostic tool. Therefore, MRMC studies and AI assistance are not relevant.

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

Not applicable. This device is a medical implant, not an algorithm or AI.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable. For this 510(k) submission, the "ground truth" for the device's acceptability was its demonstrated substantial equivalence to a legally marketed predicate device. This is based on material composition, design intent, and intended use being sufficiently similar to not pose new questions of safety or effectiveness.

8. The sample size for the training set

Not applicable. This submission is not for an AI/ML device, so there is no training set in the AI context.

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

Not applicable. There is no training set for this device.

Summary

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OCT 2 9 2004

Summary of Safety and Effectiveness

Submitter:	Zimmer, Inc.P.O. Box 708Warsaw, IN 46581-0708
Contact Person:	Dalene BinkleyAssociate, Regulatory AffairsTelephone: (574) 372-4907Fax: (574) 372-4605
Date:	June 16, 2004
Trade Name:	NexGen® Porous, HA/TCP, Uncemented Femoraland Tibial Baseplate Components
Common Name:	Total Knee Prosthesis
Classification Nameand Reference:	Knee joint patellofemorotibial metal/polymerporous-coated uncemented prosthesis-21 CFR § 888.3565
Predicate Device:	NexGen® Porous, Uncemented Femoral and TibialBaseplate Components, manufactured by Zimmer.Inc., K031061, cleared October 9, 2003.
Device Description:	The devices included in this 510(k), are identical totheir predicates except for the addition of HA/TCP.
Intended Use:	These devices are indicated for patients with severeknee pain and disability due to rheumatoid arthritis,osteoarthritis, traumatic arthritis, polyarthritis,collagen disorders, and/or avascular necrosis of thefemoral condyle, post-traumatic loss of jointconfiguration, particularly when there ispatellofemoral erosion, dysfunction or priorpatellectomy, and moderate valgus, varus, orflexion deformities. The salvage of previouslyfailed surgical attempts or for a knee in whichsatisfactory stability in flexion cannot be obtained atthe time of surgery.

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Comparison to Predicate Device:

Performance Data (Nonclinical and/or Clinical):

These devices are identical to their predicate devices except for the addition of HA/TCP.

Non-Clinical Performance and Conclusions:

No additional testing was required.

Clinical Performance and Conclusions:

Clinical data and conclusions were not needed for this device.

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OCT 2 9 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Dalene T. Binkley Associate, Regulatory Affairs Zimmer, Inc. P.O. Box 708 Warsaw, Indiana 46581-0708

Re: K041100

Trade/Device Name: NexGen® Porous, HA/TCP, 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: October 6, 2004 Received: October 7, 2004

Dear Ms. Binkley:

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

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Page 2 - Ms. Dalene T. Binkley

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.

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 (240) 276-0120. 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,

Mark A. Millerson

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

Kod 1100 510(k) Number (if known):

Device Name:

NexGen® Porous, HA/TCP, Uncemented Femoral and Tibial Baseplate Components

Indications for Use:

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark A. Milleson

(Division Sign Off)

Division of General, Restorative, and Neurological Devices

510(k) Number K09

Page I of I

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.