Device Dossier

Sigma HP Partial Uni Tibial Tray - Unicondylar knee prosthesis

Device Dossier for Sigma HP Partial Uni Tibial Tray - Unicondylar knee prosthesis (Unicondylar knee prosthesis, Class III, sponsor DePuy Synthes). ARTG…

Intended purpose

The Sigma HP Partial Uni Tibial Tray is the tibial component of the SIGMA High Performance Partial Knee System is intended to replace articulating elements of a single compartment of a damaged knee joint where there is evidence of sufficient sound bone to seat and support the components.

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