LEGION COBALT CHROME REVISION KNEE SYSTEM

K060742 · Smith & Nephew, Inc. · JWH · May 3, 2006 · Orthopedic

Device Facts

• Record ID: K060742
• Device Name: LEGION COBALT CHROME REVISION KNEE SYSTEM
• Applicant: Smith & Nephew, Inc.
• Product Code: JWH · Orthopedic
• Decision Date: May 3, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3560
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Revision Knee System components are indicated for rheumatoid arthritis; 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. The components are designed for use 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. The Revision Knee components are for single use only and are intended for implantation with bone cement.

Device Story

The LEGION Cobalt Chrome Revision Knee System is a semi-constrained knee prosthesis designed for primary and revision arthroplasty. It serves as a structural replacement for the knee joint in patients with ligamentous instability (absent or incompetent posterior cruciate and collateral ligaments). The device is a modification of the previously cleared Revision femoral components (K043440), featuring a material change from oxidized zirconium alloy (Oxinium) to cobalt chrome. It is intended for surgical implantation by orthopedic surgeons in a clinical/hospital setting. The device provides mechanical stability to the joint, allowing for weight-bearing and restoration of function in patients with severe arthritis or failed prior surgeries. It is designed for single-use and requires fixation with bone cement.

Clinical Evidence

Bench testing only. Mechanical and clinical data review indicated the system is equivalent to currently used devices and capable of withstanding expected in vivo loading without failure.

Technological Characteristics

Material: Cobalt chrome. Design: Semi-constrained knee prosthesis. Fixation: Bone cement. Classification: 21 CFR 888.3560, Class II. Single-use.

Indications for Use

Indicated for patients with rheumatoid, post-traumatic, osteoarthritis, or degenerative arthritis requiring revision or primary knee surgery; specifically for patients with absent or incompetent posterior cruciate and/or collateral ligaments (medial/lateral). Suitable for older patients with activity levels compatible with long-term results; includes cases of failed prior osteotomies or knee replacements. For single use with bone cement.

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

• Smith & Nephew Revision Knee System (K041106, K043440)
• Zimmer Legacy Constrained Condylar Knee (L-CCK)
• Biomet Oncology Salvage System (OSS)
• Sulzer Orthopedics MOST System

Submission Summary (Full Text)

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# Summary of Safety and Effectiveness

# Smith & Nephew, Inc. LEGION Cobalt Chrome Revision Knee System

## Contact Person and Address

Date of Summary: March 17, 2006

Jason Sells Regulatory Affairs Specialist Smith & Nephew, Inc. Orthopaedic Division 1450 E. Brooks Road Memphis, Tennessee 38116 [phone]

MAY ર્ 17 11:00

Name of Device: LEGION Cobalt Chrome Revision Knee System Common Name: Knee Prosthesis

## Device Description

The LEGION Cobalt Chrome Revision femoral component is a modification of the Revision femoral components cleared via K043440. The subject device is identical in design to the predicate, but the material has been changed from Oxinium, an oxidized zirconium alloy, to cobalt chrome.

#### Device Classification

21 CFR 888.3560 Knee joint patellofemorotibial polymer semi-constrained knee prosthesis - Class II

#### Mechanical and Clinical Data

A review of the mechanical and clinical data indicated that the LEGION Cobalt Chrome Revision Knee System is equivalent to devices currently used clinically and is capable of withstanding expected in vivo loading without failure.

#### Intended Use

Revision Knee System components are indicated for rheumatoid arthritis; 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. The components are designed for use 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. The Revision Knee components are for single use only and are intended for implantation with bone cement.

## Substantial Equivalence Information

The LEGION Cobalt Chrome Revision Knee System components are similar to the following commercially available devices regarding design features, overall indications, and materials:

- Smith & Nephew Revision Knee System (K041106, K043440) 디
- I Zimmer Legacy Constrained Condylar Knee (L-CCK)
- 도 Biomet Oncology Salvage System (OSS)
- 트 Sulzer Orthopedics MOST™ System

510(k) Summary.doc

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three heads, representing the department's commitment to health, human services, and science. The eagle is surrounded by the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

2 2006 MAY

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

K060742 Re:

> Trade/Device Name: Legion Cobalt Chrome Revision Knee System Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer/metal/polymer semiconstrained cemented prosthesis Regulatory Class: II Product Code: JWH Dated: April 27, 2006 Received: April 28, 2006

Dear Mr. Sells:

We have reviewed your Scction 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

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Page 2 - Mr. Jason Sells

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/industry/support/index.html.

Sincerely yours,

Mark N. Melkerson, M.S. 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

510(k) Number (if known):

Device Name: LEGION Cobalt Chrome Revision Knee System

Indications for Use:

Revision Knee System components are 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.
- The constrained knee systems are designed for use in patients in primary and বা 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.

The Revision Knee components are for single use only and are intended for implantation with bone cement.

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

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

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| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
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Division of General, Restorative, and Neurological Devices

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**510(k) Number** K060742

Indications.doc