Device Dossier

Rotating hinged total knee prosthesis

Device Dossier for Rotating hinged total knee prosthesis (Rotating hinged total knee prosthesis, Class IIb, sponsor Stryker). ARTG record, intended…

Intended purpose

An augment component of the Rotating Hinge Knee System. The Rotating Hinge Knee System is 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.

TGA Public Summary