Device Dossier
GMK Revision STD Femur TiNbN Coated Cemented - Uncoated knee femur prosthesis
Device Dossier for GMK Revision STD Femur TiNbN Coated Cemented - Uncoated knee femur prosthesis (Uncoated knee femur prosthesis, Class III, sponsor…
- GMDN category: Uncoated 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
Device is manufactured from cobalt chrome and a TiNbN coating and designed for cemented fixation. The femoral cone has 6° of Valgus orientation and two distal and posterior threaded holes to fix corresponding femoral augments. The device allows the connection with an extension stem and/or offset connector.