Knee Replacement System- Femoral
- UID
- IMP/MD/2019/000423_98d4944da9f79bb87c5122c9bbaef834_5a36c9dc0ff2eea0881f71ea2462c128
- Device class
- Class D
- Brand name
- PFC Sigma
- License holder
- Johnson & Johnson Private Limited
- Approving authority
- CDSCO
- 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) 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) 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
Knee Replacement System- Femoral is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2019/000423_98d4944da9f79bb87c5122c9bbaef834_5a36c9dc0ff2eea0881f71ea2462c128. This device is marketed under the brand name PFC Sigma. The license holder is Johnson & Johnson Private Limited, and it is classified as Device Class Class D. The approving authority is CDSCO.
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