Device Dossier

Modular Rotating Hinge Knee Tibial Insert - Rotating hinged total knee prosthesis

Device Dossier for Modular Rotating Hinge Knee Tibial Insert - Rotating hinged total knee prosthesis (Rotating hinged total knee prosthesis, Class III,…

Intended purpose

A tibial component of a 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

The tibial insert is part of a Rotating Hinge Knee System. The tibial insert is assembled to a tibial stemmed tray which incorporates a longitudinal bore to accept a tibial sleeve. It articulates with the underside of the tibial rotating component and provides motion in the rotational plane. Made from Ultra-High-Molecular-Weight Polyethylene (UHMWPE).

TGA Public Summary