Device Dossier
PFC Sigma TC3 RP Inserts - Prosthesis, knee, internal, insert component
Device Dossier for PFC Sigma TC3 RP Inserts - Prosthesis, knee, internal, insert component (Prosthesis, knee, internal, insert component, Class III,…
- GMDN category: Prosthesis, knee, internal, insert component
Intended purpose
The PFC Sigma TC3 RP 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 with osteoarthritis and rheumatoid arthritis and for revision of failed knee prostheses.
Functional description
The PFC Sigma TC3 RP Inserts are manufactured from UHMWPE and reinforced with titanium alloy pins. The PFC Sigma TC3 RP Inserts articulate with the M.B.T. primary and revision trays.