Sigma HP Partial Uni Tibial Tray - Unicondylar knee prosthesis

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Available from:

Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes

Class:

Class III

Manufactured by:

DePuy Ireland UC Loughbeg Ringaskiddy, Co Cork Ireland

Therapeutic area:

34195 - Unicondylar knee prosthesis

Therapeutic indications:

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. 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.

Authorization status:

A

Authorization date:

2019-02-12