GMK Sphere Primary Cementless Femoral Component - Coated knee femur prosthesis

Intended purpose

Device 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. If, in the opinion of the surgeon, an unequivocal indication for total knee replacement outweighs the risks associated with the age of the patient, and if limited demands regarding activity and knee joint loading can be assured, total knee replacement may be considered for young patients. This includes severely disabled patients with multiple joint involvement for whom and immediate gain in knee mobility may lead to significant improvement of their quality of life.

Functional description

GMK Sphere Primary Cementless Femoral Component is designed for use without bone cement. The GMK Sphere is a total knee prosthesis designed to achieve good AP stability and reduce early rollback and paradoxical motion. The design of the GMK Sphere is characterized by a spherical medial femoral condyle and an asymmetrical fixed tibial polyethylene insert with a concave spherical medial compartment. This tibial- femoral combination allows the medial “ball-in-socket” mechanism.