Device Dossier

GMK Primary Cemented PS Femoral Component - Uncoated knee femur prosthesis

Device Dossier for GMK Primary Cemented PS Femoral Component - Uncoated knee femur prosthesis (Uncoated knee femur prosthesis, Class III, sponsor…

Intended purpose

GMK PS Cemented 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. Candidates for total knee replacement are patients with a severely painful and/or severely disabled joint as a result of osteoarthritis, post-traumatic arthritis, rheumatoid polyarthritis, or primary implantation failure.

Functional description

The GMK PS Cemented Femoral Component 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 GMK narrow femurs have the same AP dimension as the corresponding size, but with a decreased (2mm per side) ML dimension.

TGA Public Summary