Device Dossier

Sigma HP Partial Uni Knee Fixed Bearing Insert - Unicondylar knee insert

Device Dossier for Sigma HP Partial Uni Knee Fixed Bearing Insert - Unicondylar knee insert (Unicondylar knee insert, Class III, sponsor DePuy Synthes).…

Intended purpose

Sigma HP Partial Uni Knee Fixed Bearing Insert is the bearing 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 articular surfaces or a history of gout or pseudogout.

Functional description

Sigma HP Partial Uni Knee Fixed Bearing Insert is a unicondylar insert manufactured of XLK UHMWPE and locks into the corresponding Sigma HP Partial Tibial tray and articultes with the femoral component.

TGA Public Summary