Device Dossier

PFC Sigma Oval Dome Patella 3 Peg - Polyethylene patella prosthesis

Device Dossier for PFC Sigma Oval Dome Patella 3 Peg - Polyethylene patella prosthesis (Polyethylene patella prosthesis, Class III, sponsor DePuy…

Intended purpose

The PFC Sigma Oval Dome Patella 3 Peg is a patella resurfacing component which articulates with a prosthetic femoral component in total knee arthroplasty. The PFC Sigma Knee System is intended to provide increased patient mobility and reduce pain by replacing the damaged knee joint articulation in skeletally mature patients with a severely painful knee and impaired knee function where there is evidence of sufficient sound bone to seat and support the components. Its indications include: - A severely painful and/or disabled joint (typically due to non inflammatory degenerative joint disease) - Failed previous knee surgery

Functional description

The PFC Sigma Oval Dome Patella 3 Peg is an artificial patella made of polyethylene and implanted during primary or revision knee joint replacement. It is designed to articulate with a prosthetic femoral component and is implanted on the back of the natural patella with fixation achieved via the 3 pegs and bone cement.

TGA Public Summary