PFC Sigma MBT Porous Tibial Tray - Coated knee tibia 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 Orthopaedics Inc 700 Orthopaedic Drive, Warsaw, IN, 46582 United States Of America

Therapeutic area:

34198 - Coated knee tibia prosthesis

Therapeutic indications:

The PFC Sigma MBT Porous Tibial Tray is designed to replace the tibial condyles during bicondylar replacement of the knee joint and is made of cobalt chrome. The device is designed to hold the mobile bearing insert which articulates with the femoral prosthetic component of the knee joint. It is porous coated and intended for cementless applications. The PFC Sigma MBT Porous Tibial Tray is the tibial resurfacing component which holds the mobile bearing insert 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. Candidates for total knee replacement include patients with a severely painful and/or severely disabled joint resulting from osteoarthritis, post-traumatic arthritis, rheumatoid arthritis, or failed previous implant.

Authorization status:

A

Authorization date:

2014-08-08