Device Dossier

PFC Sigma Stabilised XLK Fixed Bearing Insert - Prosthesis, knee, internal, insert component

Device Dossier for PFC Sigma Stabilised XLK Fixed Bearing Insert - Prosthesis, knee, internal, insert component (Prosthesis, knee, internal, insert…

Intended purpose

The PFC Sigma Stabilised XLK Fixed Bearing 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.

Functional description

The PFC Sigma Stabilised XLK Fixed Bearing Insert articulates with the femoral implant and snap locks into the tibial tray of a knee joint prosthesis. It is a one-piece contoured polyethylene (PE) insert.

TGA Public Summary