Knee Replacement System - Femoral - India CDSCO Medical Device Registration

Product Information

The P.F.C. SIGMA RP Mobile Bearing Total Knee System is indicated for cemented use in cases of osteoarthritis and rheumatoid arthritis. The RPF and RPS inserts and femoral components are indicated where a higher than normal degree of post-operative flexion is required. The rotating platform prosthesis and modular revision components are indicated for revision of failed knee prostheses. The porous coated Keeled and Non Keeled M.B.T. (PFC Sigma RPF) Tray configurations of the LCS Total Knee System are indicated for noncemented use in skeletally mature individuals undergoing primary surgery for reconstructing knees damaged as a result of noninflammatory degenerative joint disease (PFC Sigma RPF) or either of its composite diagnoses of osteoarthritis and post-traumatic arthritis pathologies. The Rotating Platform device configuration is indicated for use in knees whose anterior and posterior cruciate ligaments are absent or are in such condition as to justify their sacrifice. The P.F.C. SIGMA RP Curved bearings when used with the P.F.C. SIGMA Cruciate Retaining femoral component can be used in posterior cruciate ligament retaining procedures