PFC Sigma Curved All Poly Tibia - Uncoated knee tibia prosthesis, polyethylene

Country: Ավստրալիա

language: անգլերեն

source: Department of Health (Therapeutic Goods Administration)

MAH:

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_indication:

The PFC Sigma Curved All Poly Tibia is made from polyethylene, is uuncoated and intended for cemented fixation. It is a one piece tibial component/insert that is fixated into the tibia and articulates with the femoral component. The PFC Sigma Curved All Poly Tibia is a one piece tibial/insert 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 a failed previous implant.

authorization_status:

A

authorization_date:

2014-02-14