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…
- GMDN category: Rotating hinged total knee prosthesis
- Sponsor: Stryker
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.