Device Dossier

Kinematic Rotating Hinge Knee Tibial Bearing Component - Long - Rotating hinged total knee prosthesis

Device Dossier for Kinematic Rotating Hinge Knee Tibial Bearing Component - Long - Rotating hinged total knee prosthesis (Rotating hinged total knee…

Intended purpose

A tibial bearing 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 bearing component of a Rotating Hinge Knee System, connected to the femoral component by a set of bushings and an axle. A bumper locks this assembly. 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 an translation in the axial plane. Manufactured from VITALLIUM Alloy.

TGA Public Summary