Device Dossier

Modular Rotating Hinge Knee System Crossover Tibial Bearing Component - Rotating hinged total knee prosthesis

Device Dossier for Modular Rotating Hinge Knee System Crossover Tibial Bearing Component - Rotating hinged total knee prosthesis (Rotating hinged total…

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

Tibial Bearing component assembled intraoperatively with a set of bushings and an axle and a bumper.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 VITALLIUM Alloy.

TGA Public Summary