Device Dossier
MRH Tibial Bearing Component (Reverse Crossover) - Uncoated knee tibia prosthesis, metallic
Device Dossier for MRH Tibial Bearing Component (Reverse Crossover) - Uncoated knee tibia prosthesis, metallic (Uncoated knee tibia prosthesis, metallic,…
- GMDN category: Uncoated knee tibia prosthesis, metallic
- Sponsor: Stryker
Intended purpose
A tibial bearing component of a Modular Rotating Hinge Knee System, intended to be implanted in 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
This Tibial Bearing component is assembled intraoperatively with a set of bushings and an axle, a bumper locks this assembly (supplied separately). This assembly provides motion through the axle/bushing combination in the flexion/extension plane. The stem of the tibial bearing component fits into the polyethylene tibial component or insert which is fixed to the tibia, providing motion in the rotational plane and translation in the axial plane. Made from forged VITALLIUM Alloy.