Device Dossier
Knee tibia prosthesis plug
Device Dossier for Knee tibia prosthesis plug (Knee tibia prosthesis plug, Class IIb, sponsor Stryker). ARTG record, intended purpose, GMDN category —…
- GMDN category: Knee tibia prosthesis plug
- Sponsor: Stryker
Intended purpose
The end cap component of the Triathlon Hinge Knee System, intended to be implanted with bone cement for the following condition(s): - There is destruction of the joint surfaces, with or without significant bone deformity. - The cruciate and/or collateral ligaments do not stabilize the knee joint. - The ligaments are inadequate and/or the musculature is weak. And/or - Revision is required of a failed prosthesis where there has been gross instability, with or without bone loss or inadequate soft tissue. When used with MRH femur and/or MRH tibial baseplate replacement indicated in revision of an existing prosthesis: - Revision is required of a failed prosthesis where there has been gross instability, with or without bone loss or inadequate soft tissue.