Device Dossier

GMRS Tibial Rotating Component for Small Proximal Tibial Bearing Component - Uncoated knee tibia prosthesis, metallic

Device Dossier for GMRS Tibial Rotating Component for Small Proximal Tibial Bearing Component - Uncoated knee tibia prosthesis, metallic (Uncoated knee…

Intended purpose

A tibial rotating component of the Modular Replacement System, intended for use in patients requiring extensive reconstruction of the knee joint, necessitated by extensive bone loss due to trauma, failed previous prosthesis and/or tumor resection.

Functional description

A tibial bearing component of a Rotating Hinge Knee System, connected to the femoral component by a set of bushings and an axle. A bumper locks this assembly. The stem of the tibial bearing component fits into the polyethylene tibial component or insert which is fixed to the tibia, providing motion in the rotational plane an translation in the axial plane. Manufactured from Vitallium.

TGA Public Summary