Device Dossier

PFC Sigma TC3 Femur - Uncoated knee femur prosthesis

Device Dossier for PFC Sigma TC3 Femur - Uncoated knee femur prosthesis (Uncoated knee femur prosthesis, Class III, sponsor DePuy Synthes). ARTG record,…

Intended purpose

The PFC Sigma TC3 Femur is the femoral component of a total knee arthroplasty and for revision of failed knee prostheses. It 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.

Functional description

The PFC Sigma TC3 Femoral is manufactured from Co-Cr-Mo alloy and is uncoated for cemented fixation. The femoral condylar component matches the tibial bearing component. The femoral components are available in right and left configurations. The PFC Sigma TC3 Femorals allow for the attachment of femoral augments, sleeves, and ancillary P.F.C. stem extensions to provide additional stability to accommodate for femoral bone loss.

TGA Public Summary