Device Dossier

Kinematic Rotating Hinge Knee - All Poly Tibia - Rotating hinged total knee prosthesis

Device Dossier for Kinematic Rotating Hinge Knee - All Poly Tibia - Rotating hinged total knee prosthesis (Rotating hinged total knee prosthesis, Class…

Intended purpose

A tibial component 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

A tibial component of a Rotating Hinge Knee System that is fixed into the tibia and designed to accept the Long All Poly Tibial bearing Component. This assembly provides motion in the rotational plane an translation in the axial plane. The tibial bearing is connected to the femoral component by a set of bushings and an axle, where a bumper locks this assembly. Manufactured from Ultra-High-Molecular-Weight Polyethylene (UHMWPE).

TGA Public Summary