Smith & Nephew Wins Gender Knee System Clearance
Memphis, TN - Smith & Nephew, Inc.'s Orthopaedic Reconstruction business recently announced FDA clearance for Smith & Nephew's JOURNEY Bi-Cruciate Stabilized (BCS) Knee System, the GENESIS II Total Knee System and the LEGION Revision Knee System product lines for gender specificity product requirements. This gives Smith & Nephew the largest breadth of knee products cleared for gender specific attributes, affirming the company as market leader with a range of customized products to meet changing needs of active, informed patients. 
Unlike competitive knee systems being marketed as gender specific, Smith & Nephew offers the only anatomic tibial baseplate for both the right and left knees. The asymmetric design of the tibial baseplates used in the Smith & Nephew system ensures an anatomically accurate fit of the tibial baseplate component to the proximal tibia for male and female components. In order to substantiate said claims, Smith & Nephew analyzed the gender and sizing distribution of over 1,300 GENESIS II implants, reviewed over 300 CT scans, and analyzed 200 knee replacement procedures.
"Smith & Nephew knee products have long been solutions for active, informed patients," said Joseph DeVivo, president of Smith & Nephew Orthopaedic Reconstruction. "This recent FDA clearance demonstrates that our knee reconstruction product line offers a breadth of individualized implant solutions designed to treat patients suffering from knee osteoarthritis that provide both the fit and function necessary to regain an active lifestyle. Our mission is to meet needs of all individuals and provide the best possible products for both men and women who want more than ever to regain their passion for life."
Dr. Steven B. Haas, Chief of the Knee Service at Hospital for Special Surgery in New York, explained: "With this clearance, doctors and patients are now afforded choices to make more informed decisions and ensure the optimal outcome."
This confirms the size and shape of the GENESIS II Knee System has incorporated unique features of both men and women since its introduction in 1996. With over 500,000 implanted worldwide, the GENESIS II Knee System has the longest clinical follow up of any knee cleared for gender specificity. The JOURNEY Bi-Cruciate Stabilized Knee System, Smith & Nephew's most recently introduced total knee product, was developed using over 50 design iterations in order to optimize the shape and fit of the component. The unique design features of the JOURNEY Knee System provide function for both the anterior cruciate ligament (ACL) and the posterior cruciate ligament (PCL) and result in improved stability and motion in both males and females. The LEGION Revision Knee System meets the unique demands of revision surgery and is the only dedicated revision component for gender specific attributes.
These systems feature Smith & Nephew's proprietary OXINIUM technology, a superior metal for use in production of knee and hip implants. This advanced material exhibits exceptional performance due to hardness, low-friction and resistance to roughening and abrasion. With its negligible nickel content, OXINIUM Oxidized Zirconium has been found to be more hypoallergenic than previously available materials in hip and knee replacements.
About OXINIUM Oxidized Zirconium
OXINIUM material is a unique and advanced bearing product technology created through a proprietary manufacturing process that transforms the surface to a ceramic, resulting in a material that incorporates the best features of ceramic and metal while avoiding the limitations associated with either material. OXINIUM material is a revolutionary technology used in the production of components of knee and hip implants that exhibits superior performance characteristics due to its hardness, low-friction and resistance to roughening and abrasion.
The concept of using oxidized zirconium as a joint replacement material was developed by the many individuals within Smith & Nephew Orthopaedic's Research, Development, and Manufacturing groups. OXINIUM technology has been modeled on the highly successful GENESIS II knee system, which itself has been utilized in excess of 500,000 surgeries worldwide. The first oxidized zirconium component was implanted in 1995. Since then, over 100,000 hip and knee components have been implanted with remarkable success.
SOURCE: Smith & Nephew