Device Dossier

GMK Revision PS Femur TiNbN Coated Cemented - Uncoated knee femur prosthesis

Device Dossier for GMK Revision PS Femur TiNbN Coated Cemented - Uncoated knee femur prosthesis (Uncoated 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

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.

TGA Public Summary