PFC Sigma TC3 Fixed Bearing Inserts - Prosthesis, knee, internal, insert component

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:

46585 - Prosthesis, knee, internal, insert component

Therapeutic indications:

The PFC Sigma TC3 Fixed Bearing Inserts are made from UHMWPE and reinforced with titanium pins. The pin is part of the spine and protrudes down through the bottom of the insert. It is inserted into the hole of the modular tibial tray. The PFC Sigma TC3 Fixed Bearing Insert locks into the tibial tray and articulates with the femoral component. P.F.C Sigma TC3 Tibial Fixed Bearing Inserts are offered in the same sizes as the femoral components with dimensions that correspond to the tibial tray. The PFC Sigma TC3 Fixed Bearing Insert is the articulating component of a total knee arthroplasty and for revision of failed knee prostheses. It is intended to provide increased patient mobility and reduced pain by replacing the damaged knee joint articulation 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:

2014-08-21