This system is to be used to treat gross knee instability resulting from loss of collateral ligament function, gross bone loss possibly including the insertion points of the collateral ligaments or patella tendon, or comminuted fractures of the proximal tibia or distal femur. Patients requiring hinged knees typically fall into one of four categories; 1) revision knee procedure 2) oncology 3) trauma or 4) severe varus/valgus primary knees.

Rheumatoid arthritis.
Post-traumatic arthritis, ostecarthritis, 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 incompetent and the collateral ligaments remain intact.
Constrained and hinge 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.

The Legion Hinge Knee System is for Cemented Use Only.

Device Description

Subject of this pre-market notification is the LEGION Hinge Knee system. This is an extension to the LEGION Revision system. This system broadens the complexity of cases which can be addressed with LEGION by offering a hinged option which can be used in cases of inadequate ligament stability of the knee or gross femoral/tibial bone loss. Instrumentation is to be minimized by using many of the LEGION Revision instruments. This system is to include femoral and tibial revision components, tibial inserts, distal femoral and proximal tibial segments, stems, cones and wedges as well as the instruments and trials required to implant the components. The tibial component includes a rotating platform option.

AI/ML Overview

This document is a 510(k) premarket notification for the Smith & Nephew Legion Hinge Knee system. It is a submission to the FDA to demonstrate substantial equivalence to existing legally marketed devices, not a study evaluating the performance of the device against specific acceptance criteria. Therefore, the requested information regarding acceptance criteria and a study proving the device meets those criteria is not present in this document.

The document focuses on:

Intended Use and Indications for Use: Describing the conditions for which the device is designed.
Device Description: Outlining the components and functionality of the knee system.
Substantial Equivalence Information: Comparing the device to predicate devices already on the market. This is the primary method used to "prove" the device's safety and effectiveness in a 510(k) submission – by demonstrating it is as safe and effective as a legally marketed device, not by presenting new performance data against specific acceptance criteria.
FDA Clearance Letter: Indicating that the device has been cleared for market based on the substantial equivalence argument.

Therefore, I cannot provide the requested table of acceptance criteria, reported device performance, or details about a study evaluating these criteria from the provided text. The 510(k) process relies on demonstrating equivalence to predicate devices, not on proving performance against a set of new acceptance criteria through a specific study as would be seen for a novel device or in a clinical trial setting.

Summary

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510(K) Summary Smith & Nephew Legion Hinge Knee

JUL 23 2008

SUBMITTER'S NAME:	Smith & Nephew, Inc., Orthopaedic Division
SUBMITTER'S ADDRESS:	1450 East Brooks Road, Memphis, TN 38116
SUBMITTER'S TELEPHONE NUMBER:	901-399-6017
CONTACT PERSON:	Nicholas B. Tabrizi
DATE SUMMARY PREPARED:	April 15, 2008
TRADE OR PROPRIETARY DEVICE NAME:	Smith & Nephew Legion Hinge Knee
COMMON OR USUAL NAME:	Total Knee Joint
CLASSIFICATION NAME:	Prosthesis, Knee, Femorotibial Constrained,
	Cemented,Metal/Polymer
DEVICE CLASS:	Class II
PANEL CODE:	Orthopaedics/87/KRO

A. INTENDED USE:

B. INDICATIONS FOR USE:

1. Rheumatoid arthritis.
1. Post-traumatic arthritis, ostecarthritis, 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 incompetent and the collateral ligaments remain intact.
1. Constrained and hinge 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.

The Legion Hinge Knee System is for Cemented Use Only.

C. DEVICE DESCRIPTION:

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D. SUBSTANTIAL EQUIVALENCE INFORMATION:

The Smith & Nephew Legion Hinge Knee is similar to the following commercially available devices regarding design features, overall indications, materials, sterilization and manufacturing:

Manufacturer	Description	510(K)	Clearance Date
Biomet	Orthopaedic Salvage System(OSS)	K02757	11/24/2000
Plus Orthopedics AG	RT PLUS Solution System	K023667	12/24/2000
Zimmer	Nexgen Complete KneeSolution Rotating Hinge Knee	K013385	1/9/2002

E. SUMMARY OF TECHNOLOGICAL COMPARISON:

The intended use, design, and materials of the Smith & Nephew Legion Hinge Knee are substantially equivalent to the systems listed above.

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Image /page/2/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 stripes forming its body and wing. The logo is surrounded by text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Smith & Nephew, Inc. Orthopaedic Division % Mr. Nicholas B. Tabrizi Regulatory Affairs Specialist II 1450 East Brooks Road Memphis, TN 38116

K081111 Trade/Device Name: Smith & Nephew Legion Hinge Knee System Regulation Number: 21 CFR 888.3510 Regulation Name: Knee joint femorotibial metal/polymer constrained cemented prosthesis Regulatory Class: II Product Code: KRO Dated: April 15, 2008 Received: April 24, 2008

JUL 2 3 2008

Dear Mr. Tabrizi:

Re:

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 - Mr. Nicholas B. Tabrizi

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance. please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Mark M. Millman

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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510(k) Number (if known):

08/111

Device Name: Smith & Nephew Legion Hinge Knee System

Indications for Use:

Rheumatoid arthritis. 1.
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 incompetent and the collateral ligaments remain intact.
1. Constrained and hinge 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 ligament) are absent or incompetent.

The Legion Hinge Knee System is for Cemented Use Only.

Prescription Use × (Part 21 CFR 801 Subpart D)

AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of _1

Division of General, Restorative, and Neurological Devices

510(k) Number

Regulation Number and Section

§ 888.3510 Knee joint femorotibial metal/polymer constrained cemented prosthesis.

(a)
Identification. A knee joint femorotibial metal/polymer constrained cemented prosthesis is a device intended to be implanted to replace part of a knee joint. The device limits translation or rotation in one or more planes and has components that are linked together or affined. This generic type of device includes prostheses composed of a ball-and-socket joint located between a stemmed femoral and a stemmed tibial component and a runner and track joint between each pair of femoral and tibial condyles. The ball-and-socket joint is composed of a ball at the head of a column rising from the stemmed tibial component. The ball, the column, the tibial plateau, and the stem for fixation of the tibial component are made of an alloy, such as cobalt-chromium-molybdenum. The ball of the tibial component is held within the socket of the femoral component by the femoral component's flat outer surface. The flat outer surface of the tibial component abuts both a reciprocal flat surface within the cavity of the femoral component and flanges on the femoral component designed to prevent distal displacement. The stem of the femoral component is made of an alloy, such as cobalt-chromium-molybdenum, but the socket of the component is made of ultra-high molecular weight polyethylene. The femoral component has metallic runners which align with the ultra-high molecular weight polyethylene tracks that press-fit into the metallic tibial component. The generic class also includes devices whose upper and lower components are linked with a solid bolt passing through a journal bearing of greater radius, permitting some rotation in the transverse plane, a minimal arc of abduction/adduction. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.