Device Dossier

Triathlon Hinge Bumper - Rotating hinged total knee prosthesis

Device Dossier for Triathlon Hinge Bumper - Rotating hinged total knee prosthesis (Rotating hinged total knee prosthesis, Class III, sponsor Stryker).…

Intended purpose

A bumper component of the Rotating Hinge System, intended to be implanted with bone cement for the following condition(s): - There is a 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.

Functional description

The Triathlon Hinge Bumper is a component of the Triathlon Hinge Knee System, a tricompartmental knee system. The bumper locks the assembly consisting of a bossed femoral component and a stemmed tibial rotating component that are connected by a set of bushings and an axle. This assembly allows for motion through the axle/bushing combination in the flexion/extension plane.

TGA Public Summary