Device Dossier

Sigma RP-F Tibial Inserts - Prosthesis, knee, internal, insert component

Device Dossier for Sigma RP-F Tibial Inserts - Prosthesis, knee, internal, insert component (Prosthesis, knee, internal, insert component, Class III,…

Intended purpose

The Sigma RP-F tibial inserts are part of the LCS Complete ± P.F.C. Sigma RP Mobile Bearing Total Knee System and are indicated for use in cases of osteoarthritis and rheumatoid arthritis. The Sigma RP-F inserts are indicated where a higher than normal degree of post-operative flexion is required.

Functional description

The Sigma RP-F Tibial inserts are manufactured from UHMWPE and reinforced with ASTM F-90 Co-Cr-Mo alloy pins. The Sigma RP-F tibial inserts articulate with the Sigma RP-F femoral component and M.B.T. primary and revision trays.

TGA Public Summary