Device Dossier

GMRS DISTAL FEMORAL COMPONENT - Uncoated knee femur prosthesis

Device Dossier for GMRS DISTAL FEMORAL COMPONENT - Uncoated knee femur prosthesis (Uncoated knee femur prosthesis, Class III, sponsor Stryker). ARTG…

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

The GMRS DISTAL FEMORAL COMPONENT is a component of a Distal Femoral Replacement System and is available in either small or standard sizes with left or right configuration and is compatible with components of HOWMEDICA OSTEONICS Rotating Hinge Knee Systems. Is manufactured from Vitallium (cobalt-chromium-molybdenum alloy) and is intended for cemented use only.

TGA Public Summary