Device Dossier

Modular Rotating Hinge Knee System Tibal Baseplate - Rotating hinged total knee prosthesis

Device Dossier for Modular Rotating Hinge Knee System Tibal Baseplate - Rotating hinged total knee prosthesis (Rotating hinged total knee prosthesis,…

Intended purpose

A device used to repair or replace the tibial plateau of the knee joint. Rotating Hinge Knee Systems are 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

A sterile implantable Tibial Tray/Baseplate, designed to connect with Tibial Component of the Modular Rotating Hinge (MRH) Knee System. The device has a longitudinal bore to accept a tibial sleeve. Has a keel design and is compatible with a Stem Extender to maximise surgical options. For cemented use only, made from cast CoCr molybdenum alloy (VITALLIUM Alloy).

TGA Public Summary