PFC Sigma Posterior Stabilised All Poly Insert - Uncoated knee tibia prosthesis, polyethylene

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 Orthopaedics Inc 700 Orthopaedic Drive, Warsaw, IN, 46582 United States Of America

Therapeutic area:

33580 - Uncoated knee tibia prosthesis, polyethylene

Therapeutic indications:

The PFC Sigma Posterior Stabilised All Poly Insert replaces the tibial condyles during bicondylar replacement of the knee joint; it is made entirely of polyethylene. The device is designed to articulate directly with the femoral prosthetic component and its implantation is intended to be performed with bone cement. The PFC Sigma Posterior Stabilised All Poly Insert is the tibial component of a total knee arthroplasty. It 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.

Authorization status:

A

Authorization date:

2014-12-12