Rheumatoid arthritis.
Post-traumatic arthritis, osteoarthritis, or degenerative arthritis in older patients whose age, weight, and activity level are compatible with an adequate long-term result.
Failed osteotomies, unicompartmental replacement, or total knee replacement.
Posterior stabilized knee systems are designed for use in patients in primary and revision surgery, where the anterior and posterior cruciate ligaments are absent or incompetent and the collateral ligaments remain intact.

The Genesis II Posterior Stabilized High Flexion Articular Insert is used with existing cemented femoral, tibial tray, and patellar components of the Genesis II Total Knee System cleared via K951987 and K953274. The Genesis II Posterior Stabilized High Flexion Articular Insert is for single use only.

The Genesis II Posterior Stabilized High Flexion Articular Insert is used with existing cemented patellar and uncemented porous tibial trays and femoral components of the Genesis II Total Knee System cleared via K030612. The Genesis II Posterior Stabilized High Flexion Articular Insert is for single use only.

Device Description

The Genesis II Posterior Stabilized High Flexion Articular Inserts are URMWPE tibial components which provide the ability for greater flexion to those patients who have the anatomical capability to allow a greater flexion range. The insert is used with existing cemented femoral, tibial tray, and patellar components of the Genesis II Total Knee System cleared via K951987 and K953274 or with the system's porous, uncemented femoral and tibial tray components cleared in K030612.

AI/ML Overview

This document describes the Genesis II Posterior Stabilized High Flexion Articular Insert, a knee implant component.

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

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criterion	Reported Device Performance Description
Mechanical Equivalence	"A review of the mechanical test data indicated that the Genesis II Posterior Stabilized High Flexion Articular Insert is equivalent to devices currently used clinically and is capable of withstanding expected in vivo loading without failure."
Substantial Equivalence	"The substantial equivalence of the Genesis II Posterior Stabilized High Flexion Articular Insert is based on its similarities in indications for use, design features, operational principles, and material composition" to identified predicate devices.

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

The document refers to "mechanical test data," but it does not specify the sample size used for these tests.
The provenance of the data (country of origin, retrospective/prospective) is not mentioned.

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

The document does not mention any experts being used to establish a "ground truth" for the mechanical test data. The determination appears to be based on direct mechanical evaluation and comparison to existing devices.

4. Adjudication Method for the Test Set

There is no mention of an adjudication method as this type of study is not applicable to the mechanical testing described.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study

A multi-reader multi-case (MRMC) comparative effectiveness study was not performed, nor is it applicable for this type of medical device (knee implant component). The focus is on mechanical and design equivalence, not interpretative tasks.

6. Standalone (Algorithm Only) Performance

A standalone performance study was not done, nor is it applicable as this is a physical medical device, not an algorithm or AI.

7. Type of Ground Truth Used

The ground truth used for the acceptance criteria appears to be:

Mechanical performance standards/benchmarks: The device's mechanical test data was compared against "expected in vivo loading" and demonstrated equivalence to "devices currently used clinically."
Predicate device characteristics: Substantial equivalence relies on comparisons in "indications for use, design features, operational principles, and material composition" to existing legally marketed devices.

8. Sample Size for the Training Set

This information is not applicable. The device is a physical knee implant component, not an AI or machine learning model that would require a training set.

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

This information is not applicable for the same reason as point 8.

Summary

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Smith & Nephew, Inc. Summary of Safety and Effectiveness Genesis II P/S High Flexion Articular Insert

Date of Summary: August 20, 2003

Contact Person and Address Jason Sells Regulatory/Clinical Affairs Specialist I Smith & Nephew, Inc. Orthopaedic Division 1450 East Brooks Road Memphis, TN 38116

Name of Device: Genesis II Postcrior Stabilized High Flexion Articular Insert Common Name: Articular insert

Device Description

(901) 399-5520

The Genesis II Posterior Stabilized High Flexion Articular Inserts are URMWPE tibial components which provide the ability for greater flexion to those patients who bave the anatomical capability to allow a greater flexion range. The insect is used with existing cemented femoral, tibial tray, and patellar components of the Genesis II Total Knee System cleared via K951987 and K953274 or with the system's porous, uncemented femoral and tibial tray components cleared in K030612.

Identification ofDevice	Product Code	Classification Name	Code	Predicate 510(k)	Indications for Use		Predicate 510(k)
Genesis II PSHigh Flex Insertfor use withGenesis II TotalKnee SystemComponents incementedapplications	JWH -OrthopedicsPanel/87	Knee jointpatellofemorotibialpolymer/metal/polymersemi-constrainedcemented prosthesis -Class II	21 CFR888.3560	K951987 K953274	Identification of Device	Indications for Use
Genesis II PSHigh Flex Insertfor use withGenesis II TotalKnee SystemComponents inuncementedapplications	MBH -OrthopedicsPanel/87	Knee jointpatellofemorotibialmetal/polymer porous-coated uncementedprosthesis - Class II	21 CFR888.3565	K030612	Genesis II PSHigh Flex Insertfor use withGenesis II TotalKnee SystemComponents incementedapplications	The Genesis II Posterior Stabilized High Flexion Articular Insertis indicated for:1. Rheumatoid arthritis.2. Post-traumatic arthritis, osteoarthritis, or degenerativearthritis in older patients whose age, weight, and activitylevel are compatible with an adequate long-term result.3. Failed osteotomies, unicompartmental replacement, ortotal knee replacement.4. Posterior stabilized knee systems are designed for use inpatients in primary and revision surgery, where theanterior and posterior cruciate ligaments are absent orincompetent and the collateral ligaments remain intact.The Genesis II Posterior Stabilized High Flexion Articular Insertis used with existing cemented femoral, tibial tray, and patellarcomponents of the Genesis II Total Knee System cleared viaK951987 and K953274. The Genesis II Posterior Stabilized HighFlexion Articular Insert is for single use only.	K951987 K953274
Genesis II PSHigh Flex Insertfor use withGenesis II TotalKnee SystemComponents inuncementedapplications	The Genesis II Posterior Stabilized High Flexion Articular Insertis indicated for:1. Rheumatoid arthritis.2. Post-traumatic arthritis, osteoarthritis, or degenerativearthritis in older patients whose age, weight, and activitylevel are compatible with an adequate long-term result.3. Failed osteotomies, unicompartmental replacement, ortotal knee replacement.4. Posterior stabilized knee systems are designed for use inpatients in primary and revision surgery, where theanterior and posterior cruciate ligaments are absent orincompetent and the collateral ligaments remain intact.The Genesis II Posterior Stabilized High Flexion Articular Insertis used with existing cemented patellar and uncemented poroustibial trays and femoral components of the Genesis II Total KneeSystem cleared via K030612. The Genesis II Posterior StabilizedHigh Flexion Articular Insert is for single use only.	K030612

Device Classification

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Mechanical and Clinical Data

A review of the mechanical test data indicated that the Genesis II Posterior Stabilized High Flexion Articular Insert is equivalent to devices currently used clinically and is capable of withstanding expected in vivo loading without failure.

Substantial Equivalence Information

The substantial equivalence of the Genesis II Posterior Stabilized High Flexion Articular Insert is based on its similarities in indications for use, design features, operational principles, and material composition to the following prodicate devices - Smith & Nephew's Genesis II Total Knee System (K951987, K953274, K030612) and Zimmer's Nexgen LPS Knee System (K991581).

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. 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 symbol resembling an eagle or bird in flight, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 2 1 2003

Mr. Jason Sells Regulatory/Clinical Affairs Specialist I Smith & Nephew, Inc. Orthopaedic Division 1450 East Brooks Road Memphis, Tennessee 38116

Re: K032295

Trade/Device Names: Genesis II PS High Flex Insert for use with Genesis II Total Knee System Components in cemented applications and Genesis II PS High Flex Insert for use with Genesis II Total Knee System Components in uncemented applications Regulation Numbers: 21 CFR 888.3560 and 21 CFR 888.3565 Regulation Names: Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis and Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis Regulatory Class: II Product Codes: JWH and MBH

Dated: July 24, 2003 Received: July 25, 2003

Dear Mr. Sells:

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 10 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.

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Page 2 - Mr. Jason Sells

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.

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 vours.

Sincerely yours,

Mark A. Mcllhenny

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

Enclosures

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Genesis II Posterior Stabilized High Flexion Articular Insert Indications Statement

The Genesis II Posterior Stabilized High Flexion Articular Insert is indicated for:

1. Rheumatoid arthritis.
1. Post-traumatic arthritis, osteoarthritis, or degenerative arthritis in older patients whose age, weight, and activity level are compatible with an adequate long-term result.
1. Failed osteotomies, unicompartmental replacement, or total knee replacement.
1. Posterior stabilized knee systems are designed for use in patients in primary and revision surgery, where the anterior and posterior cruciate ligaments are absent or incompetent and the collateral ligaments remain intact.

Mark N Millenn

ivision Sion-Division of General, Restorative and Neurological Devices 510(k) Number -

Concurrence of CDRH, Office of Device Evaluation

Prescription Use (Per 21 CFR 801.109) OR

Over-the-Counter Use

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Genesis II Posterior Stabilized High Flexion Articular Insert Indications Statement

The Genesis II Posterior Stabilized High Flexion Articular Insert is indicated for:

1. Rheumatoid arthritis.
1. Post-traumatic arthritis, osteoarthritis, or degenerative arthritis in older patients whose age, weight, and activity level are compatible with an adequate long-term result.
1. Failed osteotomies, unicompartmental replacement, or total knee replacement.
1. Posterior stabilized knee systems are designed for use in patients in primary and revision surgery, where the anterior and posterior cruciate ligaments are absent or incompetent and the collateral ligaments remain intact.

Mark N Milken

Orvision of General. Restorative and Neurological I

510(k) Number .

Concurrence of CDRH, Office of Device Evaluation

Prescription Use (Per 21 CFR 801.109) ાર

Over-the-Counter Use

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.