Device Dossier

Sigma HP Partial Uni Tibial Tray - Uncoated unicondylar knee tibia prosthesis, metallic

Device Dossier for Sigma HP Partial Uni Tibial Tray - Uncoated unicondylar knee tibia prosthesis, metallic (Uncoated unicondylar knee tibia prosthesis,…

Intended purpose

The Sigma HP Partial Uni Tibial Tray is the 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 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. Intended for cemented use only.

Functional description

The Sigma HP Partial Uni Tibial Tray is a unicondylar tibial tray manufactured from CoCr. It has a metal back and is intended for cemented use. An appropriately sized cross-linked polyethylene insert is held in place with a locking mechanism.

TGA Public Summary