Device Dossier

Triathlon Hinge Tibial Bearing Component - Rotating hinged total knee prosthesis

Device Dossier for Triathlon Hinge Tibial Bearing Component - Rotating hinged total knee prosthesis (Rotating hinged total knee prosthesis, Class III,…

Intended purpose

A tibial bearing 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 Tibial Bearing Component is part of the Triathlon Hinge Knee System, a tricompartmental knee system. The system consists of a femoral component and a stemmed tibial bearing/rotating component connected by a set of bushings and an axle. A bumper locks this assembly. This assembly allows for motion through the axle/bushing combination in the flexion/extension plane. The articulation of the tibial rotating component and a tibial insert allows for motion in the rotational plane.

TGA Public Summary