PFC Sigma Duofix Insert - 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 Ireland UC Loughbeg Ringaskiddy, Co Cork Ireland

Therapeutic area:

46585 - Prosthesis, knee, internal, insert component

Therapeutic indications:

The PFC Sigma Duofix Insert articulates with the femoral component and snap locks into the tibial tray of a knee joint prosthesis. It is a one-piece contoured polyethylene insert. The PFC Sigma Duofix Insert is the articulating component of a total knee arthroplasty 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. 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:

2019-03-19