Device Dossier
GMRS Axle for Small Distal Femur - Rotating hinged total knee prosthesis
Device Dossier for GMRS Axle for Small Distal Femur - Rotating hinged total knee prosthesis (Rotating hinged total knee prosthesis, Class III, sponsor…
- GMDN category: Rotating hinged total knee prosthesis
- Sponsor: Stryker
Intended purpose
An axle of the Modular Replacement System, intended for use in patients requiring extensive reconstruction of the knee joint, necessitated by extensive bone loss due to trauma, failed previous prosthesis and/or tumor resection.
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.