Device Dossier
Modular Rotating Hinge Knee System Bumper Insert - Rotating hinged total knee prosthesis
Device Dossier for Modular Rotating Hinge Knee System Bumper Insert - Rotating hinged total knee prosthesis (Rotating hinged total knee prosthesis, Class…
- GMDN category: Rotating hinged total knee prosthesis
- Sponsor: Stryker
Intended purpose
The bumper insert 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
The bumper component of a Rotating Hinge Knee System. The bumper locks the hinge knee assembly of the femoral component, tibial bearing component, axle and a set of bushings. This assembly provides motion through the axle/ bushing combination in the flexion/ extension plane. Manufactured from Duration stabilized Ultra-High-Molecular-Weight Polyethylene (UHMWPE).