Device Dossier

GMK Spherika Femoral Component Cemented TiNbN Coated - Coated knee femur prosthesis

Device Dossier for GMK Spherika Femoral Component Cemented TiNbN Coated - Coated knee femur prosthesis (Coated knee femur prosthesis, Class III, sponsor…

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

Cemented femoral component of the GMK SpheriKA Knee System, manufactured from cobalt chrome with a TiNbN coating on the bearing surface 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.

TGA Public Summary