GENESIS II POROUS PLUS HA KNEE SYSTEM

K032683 · Smith & Nephew, Inc. · MBH · Oct 15, 2003 · Orthopedic

Device Facts

• Record ID: K032683
• Device Name: GENESIS II POROUS PLUS HA KNEE SYSTEM
• Applicant: Smith & Nephew, Inc.
• Product Code: MBH · Orthopedic
• Decision Date: Oct 15, 2003
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 888.3565
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Genesis II Total Knee System is indicated for: 1. Rheumatoid arthritis. 2. Post-traumatic arthritis, osteoarthritis, or degenerative arthritis in older patients whose age, weight, and activity levels are compatible with an adequate long-term result. 3. Failed osteotomies, unicompartmental replacement, or total knee replacement. 4. The posterior stabilized knee system is designed for use in patients in primary and revision surgery, where the anterior and posterior cruciate ligaments are incompetent and the collateral ligaments remain intact. The Genesis II Total Knee System includes porous and porous plus HA coated devices which are indicated for use with or without bone cement, and are single use devices.

Device Story

Genesis II Porous Plus HA Knee System consists of orthopedic knee components featuring hydroxyapatite (HA) coating on porous-coated surfaces. Designed for primary or revision total knee arthroplasty; used with or without bone cement. Implanted by orthopedic surgeons in clinical/hospital settings to replace diseased or damaged knee joints. HA coating facilitates biological fixation to bone. Single-use device.

Clinical Evidence

No clinical data provided; substantial equivalence based on bench testing and comparison to predicate devices.

Technological Characteristics

Metal/polymer knee prosthesis with porous coating and hydroxyapatite (HA) surface treatment. Designed for uncemented or cemented application. Single-use. Class II device.

Indications for Use

Indicated for patients with rheumatoid arthritis, post-traumatic arthritis, osteoarthritis, or degenerative arthritis requiring total knee replacement. Suitable for primary and revision surgery in patients with incompetent anterior/posterior cruciate ligaments but intact collateral ligaments. Applicable to older patients with compatible age, weight, and activity levels.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Smith & Nephew Genesis II Knee System for Uncemented Applications (K030612)
• Smith & Nephew Synergy HA on Porous Hip Stems (K002996)
• Smith & Nephew Echelon Porous Plus HA Hip Stems (K023302)

Submission Summary (Full Text)

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K032683

# 510(K) SUMMARY SMITH & NEPHEW GENESIS II KNEE SYSTEM

SUBMITTER'S NAME: SUBMITTER'S ADDRESS: SUBMITTER'S TELEPHONE NUMBER: CONTACT PERSON: DATE SUMMARY PREPARED: TRADE OR PROPRIETARY DEVICE NAME: COMMON OR USUAL NAME: CLASSIFICATION NAME:

1450 Brooks Road, Memphis, TN 38116 901-399-5153 Janet Johnson Akil August 28, 2003 Genesis II Total Knee System Total Knee Prosthesis Knee Joint Patellofemorotibial Metal/Polymer Porous-Coated Uncemented Prosthesis Class II Orthopedics/87

Smith & Nephew, Inc., Orthopaedic Division

DEVICE CLASS: PANEL CODE:

# DEVICE INFORMATION:

# A. INTENDED USE:

The Genesis II Total Knee System is indicated for:

- 1. Rheumatoid arthritis.
- 2. Post-traumatic arthritis, osteoarthritis, or degenerative arthritis in older patients whose age, weight, and activity levels are compatible with an adequate long-term result.
- Failed osteotomies, unicompartmental replacement, or total knee replacement. 3.
- 4. The posterior stabilized knee system is designed for use in patients in primary and revision surgery, where the anterior and posterior cruciate ligaments are incompetent and the collateral ligaments remain intact.

The Genesis II Total Knee System includes porous and porous plus HA coated devices which are indicated for use with or without bone cement, and are single use devices.

#### DEVICE DESCRIPTION: B.

Genesis II Porous Plus HA Knee System Components contain an HA coating on the porous coated areas of the devices. These porous plus HA components are designed for use with existing knee components contained within the Genesis II Total Knee System.

#### SUBSTANTIAL EQUIVALENCE INFORMATION: ﺰ

Genesis II Porous Plus HA Knee System Components are substantially equivalent to the Smith & Nephew Genesis II Knee System for Uncemented Applications (K030612), Smith & Nephew Synergy HA on Porous Hip Stems (K002996), and Smith & Nephew Echelon Porous Plus HA Hip Stems (K023302).

#### D. SUMMARY OF TECHNOLOGICAL COMPARISON:

The intended use, designs, and materials of the Genesis II Total Knee System are substantially equivalent to the predicate components found in the original Genesis II System submissions previously cleared by FDA. Summary report results indicate that the subject devices meet the requirements of the applicable FDA guidance documents.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image is a black and white 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 a stylized symbol that resembles an abstract human figure or a bird in flight, composed of three curved lines.

Public Health Service

OCT 1 5 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Janet Johnson Akil Director, Regulatory Affairs Smith & Nephew, Inc. Orthopaedic Division 1450 E. Brooks Road Memphis, TN 38116

Re: K032683

Trade/Device Name: Genesis II Porous Plus HA Knee System Regulation Number: 21 CFR 888.3565 Regulation Name: Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis. Regulatory Class: II Product Code: MBH Dated: August 28, 2003 Received: August 29, 2003

Dear Ms. Akil:

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 - Ms. Janet Johnson Akil

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 yours,

Mark McMillan

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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K032683

### 510(k) Number (if known):

### Device Name: Genesis II Knee System

### Indications For Use:

.

The Genesis II Total Knee System is indicated for:

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

The Genesis II Total Knee System includes porous and porous plus HA coated devices which are indicated for use with or without bone cement, and are single use devices.

# (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE) OR Prescription Use Over-The-Counter Use (Per 21 CFR 801.109) (Optional Format 1-2-96) Division of General, Restorative and Neurological I 510(k) Number

Indications Statement - Porous Plus HA Knee Components GII.doc