Device Dossier
Sigma HP Partial Uni All Poly Insert - Unicondylar knee insert
Device Dossier for Sigma HP Partial Uni All Poly Insert - Unicondylar knee insert (Unicondylar knee insert, Class III, sponsor DePuy Synthes). ARTG…
- GMDN category: Unicondylar knee insert
Intended purpose
The Sigma HP Partial Uni All Poly Insert is the bearing/tibial 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 HP 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
The Sigma HP Partial Uni All Poly Insert is a one piece XLK UHMWPE tibial tray and tibial insert and are cemented directly into the tibia and articultes with the Sigma HP Partial femoral component. Available in RM/LL or LM/RL.