Device Dossier

MRH HDP ASSEMBLY PACK - Rotating hinged total knee prosthesis

Device Dossier for MRH HDP ASSEMBLY PACK - Rotating hinged total knee prosthesis (Rotating hinged total knee prosthesis, Class III, sponsor Stryker).…

Intended purpose

A collection of devices that are designed to be used together for total reconstructive replacement 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

Components of a Rotating Hinge Knee System, consist of 2 Femoral Bushings, 1 Neutral Bumper Insert and 1 Tibial Sleeve. The set of bushings are used with an Axle to connect a stemmed Femoral Component and a stemmed Tibial Rotating Component. This assemble is locked together by the bumper insert. Tibial Baseplate and Insert house the Tibial Sleeve which articulates with the tibial rotating component. All included components are made of polyethylene (UHMWPE).

TGA Public Summary