Device Dossier
PFC Sigma Rotating Platform Stabilized Tibial Insert - Prosthesis, knee, internal, insert component
Device Dossier for PFC Sigma Rotating Platform Stabilized Tibial Insert - Prosthesis, knee, internal, insert component (Prosthesis, knee, internal,…
- GMDN category: Prosthesis, knee, internal, insert component
Intended purpose
The PFC Sigma RP Stabilised Tibial Inserts is an articulating component of the LCS Complete PFC Sigma RP Mobile Bearing Total Knee System. 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 RP Stabilised Tibial Insert articulates with the femoral component and rotates on the surface tibial tray of a knee joint prosthesis. It is a one-piece contoured polymer insert.