Device Dossier
GMK Spherika Femoral Component Cementless - Coated knee femur prosthesis
Device Dossier for GMK Spherika Femoral Component Cementless - Coated knee femur prosthesis (Coated knee femur prosthesis, Class III, sponsor Medacta).…
- GMDN category: 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.
Functional description
Cementless femoral component of the GMK SpheriKA Knee System, manufactured from cobalt chrome with Ti and HA coating for uncemented fixation, and used to replace the femoral articular surface of the knee joint. It is designed to articulate with a tibial insert and, if required, patellar prosthetic components. It is provided in left and right configurations and the trochlear groove has a ‘funnel-shaped’ design to preserve natural patella tracking.