Device Dossier
Sigma CR150 Femur - Uncoated knee femur prosthesis
Device Dossier for Sigma CR150 Femur - Uncoated knee femur prosthesis (Uncoated knee femur prosthesis, Class III, sponsor DePuy Synthes). ARTG record,…
- GMDN category: Uncoated knee femur prosthesis
Intended purpose
The Sigma CR150 Femur is one component of a Total or unicompartmental knee arthroplasty which is intended to provide increased patient mobility and reduced pain by replacing the damaged knee joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components. Total or unicompartmental knee replacement may be considered for younger patients if, in the opinion of the surgeon, an unequivocal indication for total or unicompartmental 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. This includes severely crippled patients with multiple joint involvement for whom a gain in knee mobility may lead to an expectation of significant improvement in the quality of their lives.
Functional description
The Sigma CR150 Femur is made from Cobalt Chromium and is a high flexion variant of the PFC Sigma Total Knee Replacement System. It makes available a femoral component that provides additional stability during high knee flexion (beyond 120°). The Sigma CR 150 knee provides stability in CR femoral components by providing congruent contact of the posterior femoral condyles with the tibial insert at up to 150° of flexion.