PFC Sigma Curved RP 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 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 Curved RP Insert articulates with the femoral component and rotates on the surface of the tibial tray of a knee joint prosthesis. It is a one-piece contoured UHMWPE insert. The PFC Sigma Curved RP Insert is the articulating component of a total knee arthroplasty and is intended to replace the damaged knee joint articulation in patients with osteoarthritis and rheumatoid arthritis. Indicated for use in skeletally mature individuals undergoing primary surgery for reconstructing knees damaged as a result of noninflammatory degenerative joint disease (NIDJD) or either of its composite diagnoses of osteoarthritis and post-traumatic arthritis pathologies and for revision of failed knee prostheses.

Authorization status:

A

Authorization date:

2014-08-15