Device Dossier

GMRS PROXIMAL FEMORAL COMPONENT - Uncoated hip femur prosthesis, modular

Device Dossier for GMRS PROXIMAL FEMORAL COMPONENT - Uncoated hip femur prosthesis, modular (Uncoated hip femur prosthesis, modular, Class III, sponsor…

Intended purpose

A component of a total knee joint intended to repair or replace the femoral joint of the knee. The Modular Replacement Systems are intended for use in patients requiring extensive reconstruction of the hip joint and/or knee joint, including knee fusions, necessitated by extensive bone loss due to trauma, failed previous prosthesis and/or tumor resection.

Functional description

GMRS PROXIMAL FEMORAL COMPONENT is a component of a Proximal Femoral Replacement System. Available in either standard or trochanteric shapes with neutral, left or right configurations. Compatible with components of HOWMEDICA OSTEONICS Rotating Hinge Knee Systems, assembled utilising a male/female taper locking mechanism. Includes a suture attachment feature for reattachment of the greater trochanter and other soft tissue structures. Manufactured from Vitallium (cobalt-chromium-molybdenum alloy).

TGA Public Summary