Device Dossier
Kinematic Rotating Hinge Knee Standard Axle - Rotating hinged total knee prosthesis
Device Dossier for Kinematic Rotating Hinge Knee Standard Axle - Rotating hinged total knee prosthesis (Rotating hinged total knee prosthesis, Class III,…
- GMDN category: Rotating hinged total knee prosthesis
- Sponsor: Stryker
Intended purpose
An axle component of a Rotating Hinge Knee System designed to be used in total reconstructive replacement of the knee joint for the following condition(s): 1) There is destruction of the joint surfaces, with or without significant bone deformity. 2) The cruciate and/or collateral ligaments do not stabilize the knee joint. 3) The ligaments are inadequate and/or the musculature is weak, and/or, 4) Revision is required of a failed prostheses where there has been gross instability, with or without bone loss or inadequate soft tissue.
Functional description
An axle component of a Rotating Hinge Knee System, with a set of bushings the axle connects the femoral component and tibial bearing component. A bumper locks this assembly. This assembly provides motion through the axle/bushing combination in the flexion/extension plane. Manufactured from cast VITALLIUM Alloy.