Device Dossier

HMRS Plug Screw Axis - Uncoated knee tibia prosthesis, metallic

Device Dossier for HMRS Plug Screw Axis - Uncoated knee tibia prosthesis, metallic (Uncoated knee tibia prosthesis, metallic, Class III, sponsor…

Intended purpose

An axle 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 component of a Hinge Knee System that is inserted and screwed into the axis pin to connect the femoral component, the polyethylene bearing and tibial component. The definitive axis is secured by a circlip. Manufactured from Duration stabilized Ultra-High-Molecular-Weight Polyethylene (UHMWPE).

TGA Public Summary