Device Dossier

ZMR® Hip System XL Bodies - Revision coated hip femur prosthesis

Device Dossier for ZMR® Hip System XL Bodies - Revision coated hip femur prosthesis (Revision coated hip femur prosthesis, Class III, sponsor Zimmer…

Intended purpose

The ZMR Hip System XL Body is indicated for cementless revision hip arthroplasty. Arthroplasty should be performed only when more conservative methods of treatment have failed to provide symptomatic relief or when there is progressive disability.

Functional description

A neck modular connection component of the femoral stem assembly with a 12/14 taper design to mate with the corresponding femoral head component to achieve fixation and restore joint kinematics. The component is manufactured from Tivanium® Ti-6Al-4V Alloy and is part of the stem assembly that utilizes modular junctions between the head and neck, and the metaphyseal body and diaphyseal stem segments.

TGA Public Summary