Device Dossier

GMK Primary Cementless Std Femoral Component - Coated knee femur prosthesis

Device Dossier for GMK Primary Cementless Std Femoral Component - Coated knee femur prosthesis (Coated knee femur prosthesis, Class III, sponsor…

Intended purpose

GMK Standard Cementless Femoral Component forms part of the GMK Primary Knee System that is intended to provide increased patient mobility and reduced pain by replacing the damaged knee joint, if there is evidence of sufficient sound bone to seat and support the components, and is available for primary and revision surgery. Candidates for the total knee replacement are patients with a severely painful and/or severly disabled joint as a result of osteoarthritis, post-traumatic arthritis, rheumatoid polyarthritis, or primary implantation failure.

Functional description

The GMK Standard Cementless Femoral Component is manufactured from cobalt chrome with a titanium and hydroxyapatite coating. It is a bone preserving design with an anatomic design of the trochlea to optimise patella tracking, reducing stress on the patella tendon and the risk of patella dislocation. The J-curved sagittal profile allows more natural knee kinematics, improves knee flexion and promotes rollback of the femoral component. The femur is available in a standard and narrow version.

TGA Public Summary