Device Dossier

Rotating hinged total knee prosthesis

Device Dossier for Rotating hinged total knee prosthesis (Rotating hinged total knee prosthesis, Class IIb, sponsor Zimmer Biomet). ARTG record, intended…

Intended purpose

Sterile Arcom UHMWPE bush component for use as part of an implantable artificial substitute for a knee joint typically designed to be used when replacing all the articulating surfaces of the joint [total knee replacement (TKR)] because of major loss of stabilizing structures or bone around the knee, often from tumour resection, or to replace a dysfunctional knee prosthesis (revision); it is designed with a mechanism for joint rotation and its major components are connected for stability typically about a transverse axis posterior of the rotational axis. Bush component provides a low friction interface between the axle and femoral or tibial components.

TGA Public Summary