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…
- GMDN category: Rotating hinged total knee prosthesis
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.