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 —…

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.

TGA Public Summary