Device Dossier
Sigma HP Partial Femorals - Uncoated unicondylar knee femur prosthesis
Device Dossier for Sigma HP Partial Femorals - Uncoated unicondylar knee femur prosthesis (Uncoated unicondylar knee femur prosthesis, Class III, sponsor…
- GMDN category: Uncoated unicondylar knee femur prosthesis
Intended purpose
The Sigma HP Partial Femoral is one component of the Sigma High Performance Partial Knee System and 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. The Sigma High Performance Partial Knee System is indicated for single compartmental knee replacement in skeletally mature individuals with osteoarthritis, post-traumatic arthritis of the tibiofemoral surfaces or a history of gout or pseudogout. The Sigma HP Partial Femorals are intended for cemented use only.
Functional description
The Sigma HP Partial Femorals are uncoated unicondylar femoral replacements, made out of CoCr and for cemented use. They articulate with one of the Sigma HP Partial Inserts.