Device Dossier

Modular Rotating Hinge Knee Femoral Component - Uncoated knee femur prosthesis

Device Dossier for Modular Rotating Hinge Knee Femoral Component - Uncoated knee femur prosthesis (Uncoated knee femur prosthesis, Class III, sponsor…

Intended purpose

A femoral component of a Modular Rotating Hinge Knee System, intended to be implanted with bone cement 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

Sterile implantable femoral component connected intraoperatively to a Stemmed Tibial Rotating Component via a set of bushings and an axle. A bumper locks this assembly. This assembly provides motion through the axle/bushing combination in the flexion/extension plane. Made from cast cobalt-chromium-molybdenum alloy (VITALLIUM Alloy). Articulation between cylindrical bearing surfaces on the underside of tibial rotating component and tibial insert provide motion in the rotational plane.

TGA Public Summary