GENESIS II POSTERIOR STABILIZED HIGH FLEXION ARTICULAR INSERT

K032295 · Smith & Nephew, Inc. · JWH · Aug 21, 2003 · Orthopedic

Device Facts

• Record ID: K032295
• Device Name: GENESIS II POSTERIOR STABILIZED HIGH FLEXION ARTICULAR INSERT
• Applicant: Smith & Nephew, Inc.
• Product Code: JWH · Orthopedic
• Decision Date: Aug 21, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3560
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Genesis II Posterior Stabilized High Flexion Articular Insert is indicated for: 1. Rheumatoid arthritis. 2. Post-traumatic arthritis, osteoarthritis, or degenerative arthritis in older patients whose age, weight, and activity level are compatible with an adequate long-term result. 3. Failed osteotomies, unicompartmental replacement, or total knee replacement. 4. 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. (Note: A second version of this statement exists for uncemented applications, specifying use with components cleared via K030612).

Device Story

Genesis II Posterior Stabilized High Flexion Articular Insert is a UHMWPE tibial component designed for use within the Genesis II Total Knee System. It enables increased flexion range for patients with appropriate anatomical capability. The device is intended for single use in primary or revision knee arthroplasty. It functions as part of a semi-constrained prosthesis, replacing damaged joint surfaces in patients with absent or incompetent cruciate ligaments. Surgeons implant the device in an operating room setting. The insert integrates with existing cemented or uncemented femoral, tibial tray, and patellar components. By providing a stable articulation surface, it restores joint function and mobility, potentially reducing pain and improving quality of life for patients with degenerative joint disease.

Clinical Evidence

Bench testing only. Mechanical test data demonstrated the device is equivalent to currently used clinical devices and capable of withstanding expected in vivo loading.

Technological Characteristics

Material: UHMWPE (Ultra-High Molecular Weight Polyethylene). Design: Posterior stabilized articular insert for semi-constrained knee prosthesis. Connectivity: None (mechanical component). Sterilization: Not specified.

Indications for Use

Indicated for patients with rheumatoid arthritis, post-traumatic arthritis, osteoarthritis, or degenerative arthritis requiring primary or revision total knee replacement. Suitable for patients with absent or incompetent anterior/posterior cruciate ligaments and intact collateral ligaments. Age, weight, and activity level must be compatible with long-term results.

Regulatory Classification

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).

Predicate Devices

• Genesis II Total Knee System (K951987)
• Genesis II Total Knee System (K953274)
• Genesis II Total Knee System (K030612)
• Nexgen LPS Knee System (K991581)

Submission Summary (Full Text)

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

**AUG 21 2003**

K032295

p. 1/2

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

[phone]

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 of<br>Device | Product Code | Classification Name | Code | Predicate 510(k) | Indications for Use | | Predicate 510(k) |
|-------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------|--------------------|--------------------|-----------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------|
| Genesis II PS<br>High Flex Insert<br>for use with<br>Genesis II Total<br>Knee System<br>Components in<br>cemented<br>applications | JWH -<br>Orthopedics<br>Panel/87 | Knee joint<br>patellofemorotibial<br>polymer/metal/polymer<br>semi-constrained<br>cemented prosthesis -<br>Class II | 21 CFR<br>888.3560 | K951987<br>K953274 | Identification of Device | Indications for Use | |
| Genesis II PS<br>High Flex Insert<br>for use with<br>Genesis II Total<br>Knee System<br>Components in<br>uncemented<br>applications | MBH -<br>Orthopedics<br>Panel/87 | Knee joint<br>patellofemorotibial<br>metal/polymer porous-<br>coated uncemented<br>prosthesis - Class II | 21 CFR<br>888.3565 | K030612 | Genesis II PS<br>High Flex Insert<br>for use with<br>Genesis II Total<br>Knee System<br>Components in<br>cemented<br>applications | The Genesis II Posterior Stabilized High Flexion Articular Insert<br>is indicated for:<br><br>1. Rheumatoid arthritis.<br>2. Post-traumatic arthritis, osteoarthritis, or degenerative<br>arthritis in older patients whose age, weight, and activity<br>level are compatible with an adequate long-term result.<br>3. Failed osteotomies, unicompartmental replacement, or<br>total knee replacement.<br>4. Posterior stabilized knee systems are designed for use in<br>patients in primary and revision surgery, where the<br>anterior and posterior cruciate ligaments are absent or<br>incompetent and the collateral ligaments remain intact.<br><br>The Genesis II Posterior Stabilized High Flexion Articular Insert<br>is used with existing cemented femoral, tibial tray, and patellar<br>components of the Genesis II Total Knee System cleared via<br>K951987 and K953274. The Genesis II Posterior Stabilized High<br>Flexion Articular Insert is for single use only. | K951987<br>K953274 |
| Genesis II PS<br>High Flex Insert<br>for use with<br>Genesis II Total<br>Knee System<br>Components in<br>uncemented<br>applications | The Genesis II Posterior Stabilized High Flexion Articular Insert<br>is indicated for:<br><br>1. Rheumatoid arthritis.<br>2. Post-traumatic arthritis, osteoarthritis, or degenerative<br>arthritis in older patients whose age, weight, and activity<br>level are compatible with an adequate long-term result.<br>3. Failed osteotomies, unicompartmental replacement, or<br>total knee replacement.<br>4. Posterior stabilized knee systems are designed for use inpatients in primary and revision surgery, where the<br>anterior and posterior cruciate ligaments are absent or<br>incompetent and the collateral ligaments remain intact.<br><br>The Genesis II Posterior Stabilized High Flexion Articular Insert<br>is used with existing cemented patellar and uncemented porous<br>tibial trays and femoral components of the Genesis II Total Knee<br>System cleared via K030612. The Genesis II Posterior Stabilized<br>High Flexion Articular Insert is for single use only. | K030612 | | | | | |

#### Device Classification

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

K032295

p. 2/2

### 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).

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

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.

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

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 [phone]. 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 [phone] or [phone] 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

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

K032295

p. 1/2

# 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.
- 2. Post-traumatic arthritis, osteoarthritis, or degenerative arthritis in older patients whose age, weight, and activity level are compatible with an adequate long-term result.
- 3. Failed osteotomies, unicompartmental replacement, or total knee replacement.
- 4. 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.

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

{5}------------------------------------------------

K032295

p. 2/2

# 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.
- 2. Post-traumatic arthritis, osteoarthritis, or degenerative arthritis in older patients whose age, weight, and activity level are compatible with an adequate long-term result.
- 3. Failed osteotomies, unicompartmental replacement, or total knee replacement.
- 4. 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 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.

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