Knee Replacements Designed with Gender Specifications Approved
Smith & Nephew PLC received approval from the U.S. Food and Drug Administration for their new line of knee replacements that are specifically designed with consideration of the anatomical differences between men and women. The approval was described in a press release from the company.
The three implants manufactured by Smith & Nephew are the Genesis, Legion, and Journey. The GENESIS II Total Knee System has been used over half a million times around the world and included features that consider the unique needs of men and women. Introduced in 1996, this product has data for the longest time period detailing follow-up compared to any other gender specific implant on the market. Smith & Nephew examined data from over 1,300 replacements, including 300 CT scans and the procedures from 200 different studies.
The LEGION Revision Knee System is the only knee revision product on the market for gender specific needs. The JOURNEY Bi-Cruciate Stabilized Knee System is the newest addition to the company’s line of products for the knee. Features support both the posterior and anterior cruciate ligaments (PCL, ACL). This device design affords patients with improved motion and stability.
The new implant products include the only anatomical tibial baseplates currently approved, available for both left and right knees. The products are designed assymetrically, which assures appropriate fit with the proximal tibia for every patient, regardless of gender.
As well, all of the products integrate Smith & Nephew’s OXINIUM technology, which incorporates both metal and ceramic components in manufacturing the implant. Properties of the metal include low friction, hardness, and resistance to abrasion and roughening. This material is also associated with a lower allergic profile and is, thus, more hypoallergenic than other materials used to manufacture implants.
August 30, 2007 Related topics: Product Launches, Product Approval & Certification, Orthopedic
