GENESIS II TOTAL KNEE SYSTEM, LEGION REVISION KNEE SYSTEM, JOURNEY BCS KNEE SYSTEM

K071790 · Smith & Nephew, Inc. · MBH · Aug 17, 2007 · Orthopedic

Device Facts

• Record ID: K071790
• Device Name: GENESIS II TOTAL KNEE SYSTEM, LEGION REVISION KNEE SYSTEM, JOURNEY BCS KNEE SYSTEM
• Applicant: Smith & Nephew, Inc.
• Product Code: MBH · Orthopedic
• Decision Date: Aug 17, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3565
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Total knee components are indicated for rheumatoid arthritis; post-traumatic arthritis, 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. Constrained knee systems are designed for use in patients in primary and revision surgery, where the posterior cruciate ligament and one or both of the collateral ligaments (i.e. medial collateral and/or lateral collateral ligament) are absent or incompetent. Total knee components are single use devices and may be used in cemented or uncemented applications.

Device Story

Gender Knee Systems represent existing Smith & Nephew Genesis II, Legion, and Journey BCS total knee prostheses; notification adds gender-specific marketing claims to previously cleared components. No new hardware introduced. Devices function as total knee replacements; implanted by orthopedic surgeons in clinical settings. Output is restored joint function for patients with degenerative or inflammatory arthritis. Benefit derived from anatomical sizing/design features tailored to gender-specific morphology.

Clinical Evidence

No clinical data provided; substantial equivalence based on design similarity to previously cleared devices and comparison of gender-specific claims to predicate devices.

Technological Characteristics

Total knee prosthesis consisting of metal/polymer components. Available in cemented or uncemented configurations. Design features include gender-specific geometry. No changes to materials or manufacturing processes from previously cleared Genesis II, Legion, and Journey BCS systems.

Indications for Use

Indicated for patients with rheumatoid, post-traumatic, or degenerative arthritis requiring total knee replacement, including failed osteotomies or prior unicompartmental/total knee replacement. Posterior stabilized systems indicated for primary/revision surgery with absent/incompetent cruciate ligaments and intact collateral ligaments. Constrained systems indicated for primary/revision surgery with absent/incompetent posterior cruciate and one or both collateral ligaments.

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

• Zimmer NexGen Knee Gender Solutions Female (GSF) Femoral Components (K060370)
• Zimmer Gender Solutions Natural-Knee Flex System (K070214)
• Stryker Triathlon Total Knee System (K053514)

Submission Summary (Full Text)

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# Summary of Safety and Effectiveness Smith & Nephew, Inc. Gender Knee Systems

Date of Summary: August 16, 2007

#### Contact Person and Address

Jason Sells Project Manager, Regulatory Affairs Smith & Nephew, Inc. Orthopaedic Division 1450 East Brooks Road Memphis, Tennessee 38116 T [phone]

AUG 1 7 2007

Name of Device: Smith & Nephew, Inc. Gender Knee Systems Common Name: Total Knee Prosthesis

Device Classification: 21 CFR 888.3560 (Knee joint patellofemorotibial polymer/metal/polymer semiconstrained cemented prosthesis – Class II); and 21 CFR 888.3565 (Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis - Class II)

## Device Description

The Smith & Nephew, Inc. Gender Knee Systems are the existing Smith & Nephew, Inc. Genesis II, Legion, and Journey BCS Knee Systems. This premarket notification seeks only to add gender-related claims for these existing total knee systems previously cleared by FDA marketed by Smith & Nephew. No new total knee components being introduced as a result of this premarket notification.

#### Intended Use

Total knee components are indicated for rheumatoid arthritis; post-traumatic arthritis, 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. Constrained knee systems are designed for use in patients in primary and revision surgery, where the posterior cruciate ligament and one or both of the collateral ligaments (i.e. medial collateral and/or lateral collateral ligament) are absent or incompetent. Total knee components are single use devices and may be used in cemented or uncemented applications.

#### Substantial Equivalence Information

The Smith & Nephew, Inc. Gender Knee Systems are the existing Smith & Nephew, Inc. Genesis II, Legion, and Journey BCS Knee Systems previously cleared for market by FDA through various premarket notifications. The gender-specific claims being made about these devices are similar to those of the Zimmer NexGen Knee Gender Solutions Female (GSF) Femoral Components (K060370), the Zimmer Gender Solutions Natural-Knee Flex System (K070214), and the Stryker Triathlon Total Knee System (K053514).

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Smith & Nephew, Inc. % Mr. Jason Sells Project Manager, Regulatory Affairs 1450 Brooks Road Memphis, Tennessee 38116

AUG 17 2007

Re: K071790

Trade/Device Name: Gender Knee System Regulation Number: 21 CFR 888.3565 Regulation Name: Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis Regulatory Class: Class II Product Code: MBH, JWH Dated: June 29, 2007 Received: July 2, 2007

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 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

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# Page 2 - Mr. Jason Sells

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/industry/support/index.html.

Sincerely yours,

Barbara Buell

Mark N. Melkerson 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

K071790 510(k) Number (if known):

Device Name: Smith & Nephew, Inc. Gender Knee Systems

Indications for Use:

Total knee components are indicated for rheumatoid arthritis; post-traumatic arthritis, 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. Constrained knee systems are designed for use in patients in primary and revision surgery, where the posterior cruciate ligament and one or both of the collateral ligaments (i.e. medial collateral and/or lateral collateral ligament) are absent or incompetent. Total knee components are single use devices and may be used in cemented or uncemented applications.

Prescription Use x (Part 21 CFR 801 Subpart D)

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

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AND/OR

Concurrence of CDRH, Office of Device Evaluation (ODE)

Barbara Boucher

Division of General, Restorative. and Neurological Devices

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510(k) Number_K07179i