Device Dossier
PFC Sigma TC3 Fixed Bearing Inserts - Prosthesis, knee, internal, insert component
Device Dossier for PFC Sigma TC3 Fixed Bearing Inserts - Prosthesis, knee, internal, insert component (Prosthesis, knee, internal, insert component,…
- GMDN category: Prosthesis, knee, internal, insert component
Intended purpose
The PFC Sigma TC3 Fixed Bearing Insert is the articulating 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 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 TC3 Fixed Bearing Inserts are made from UHMWPE and reinforced with titanium pins. The pin is part of the spine and protrudes down through the bottom of the insert. It is inserted into the hole of the modular tibial tray. The PFC Sigma TC3 Fixed Bearing Insert locks into the tibial tray and articulates with the femoral component. P.F.C Sigma TC3 Tibial Fixed Bearing Inserts are offered in the same sizes as the femoral components with dimensions that correspond to the tibial tray.