Device Dossier
Triathlon Hinge Insert - Rotating hinged total knee prosthesis
Device Dossier for Triathlon Hinge Insert - Rotating hinged total knee prosthesis (Rotating hinged total knee prosthesis, Class III, sponsor Stryker).…
- GMDN category: Rotating hinged total knee prosthesis
- Sponsor: Stryker
Intended purpose
A tibial insert 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 Insert is a component of the Triathlon Hinge Knee System, a tricompartmental knee system. The tibial insert is assembled to a tibial stemmed tray which incorporates a longitudinal bore to accept the sleeve of the tibial insert. The articulation between the tibial insert and the cylindrical bearing surfaces on the underside of the tibial rotating component allows for motion in the rotational plane.