Device Dossier

HMRS Rotating Hinge Knee Tibial Insert - Rotating hinged total knee prosthesis

Device Dossier for HMRS Rotating Hinge Knee Tibial Insert - Rotating hinged total knee prosthesis (Rotating hinged total knee prosthesis, Class III,…

Intended purpose

A tibial insert of a Rotating Hinge Knee System designed to be used in total reconstructive replacement of the knee joint for the following condition(s): 1) There is destruction of the joint surfaces, with or without significant bone deformity. 2) The cruciate and/or collateral ligaments do not stabilize the knee joint. 3) The ligaments are inadequate and/or the musculature is weak, and/or, 4) Revision is required of a failed prostheses where there has been gross instability, with or without bone loss or inadequate soft tissue.

Functional description

The tibial insert of a Rotating Hinge Knee System is assembled to a tibial stemmed tray/base plate, which incorporates a longitudinal bore to accept a tibial sleeve. The articulation between the cylindrical bearing surfaces on the underside of the tibial rotating component and a tibial insert provide motion in the rotational plane. Manufactured from Duration stabilized Ultra-High-Molecular-Weight Polyethylene (UHMWPE).

TGA Public Summary