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Smith & Nephew receives FDA approval to market three TKA systems as gender-specific

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Smith & Nephew received FDA approval to market three of its total knee arthroplasty product lines for gender-specific requirements, the company announced in a press release.

The approval is 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.

The Smith & Nephew systems offer an anatomic tibial baseplate for both right and left knees. The baseplates feature an asymmetric design to ensure an anatomically accurate fit of the tibial baseplate component to the proximal tibia for male and female components, according to the release.

To substantiate these claims, the company analyzed the gender and sizing distribution of over 1,300 Genesis II implants, reviewed over 300 CT scans and analyzed 200 knee replacement procedures, the release said.

The systems all feature Smith & Nephew's proprietary Oxinium technology, a unique bearing product created through a manufacturing process that transforms the surface to a ceramic. The result is a material that incorporates the best features of ceramic and metal while avoiding the limitations associated with either material, the release said.