Device Dossier

GMK Primary Femur TiNbN Coated Cemented - Coated knee femur prosthesis

Device Dossier for GMK Primary Femur TiNbN Coated Cemented - Coated knee femur prosthesis (Coated knee femur prosthesis, Class III, sponsor Medacta).…

Intended purpose

The GMK Cemented TiNbN Femur 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.

Functional description

The GMK Standard Cemented TiNbN Coated 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.

TGA Public Summary