Knee Replacement System-Tibial Wedge
- UID
- IMP/MD/2020/000556_9cf27a30e10680f0b6267055464df0ee_849ff737a108d63da5271e6e20904c7a
- Device class
- Class D
- Brand name
- Sigma PS
- License holder
- Johnson & Johnson Private Limited
- Approving authority
- CDSCO
- Product information
- The P.F.C modular plus tibial wedges and P.F.C Sigma femoral augments are indicated for use as a total knee replacement for patients suffering from severe pain and disability due to permanent structural damage resulting from rheumatoid arthritis, osteoarthritis, post- traumatic arthritis, collagen disorders or pseudogout. This damage may also be the result of trauma or failed prior surgical intervention. Choice of specific femoral and tibial components will depend upon whether the posterior cruciate ligament is retained or excised, the extent and nature of anterior/ posterior ans medial/lateral stabilization, the femoral and / or tibial aurmentation required, and the need for enhanced mechanical fixation provided by femoral and tibial stems or fluted rods. Components are indicated for use only with poymethylmethacrylate(Sigma PS) bone cement. The P.F.C tibial wedge is indicated to provide augmentation of tibial plateau with bony defects
Knee Replacement System-Tibial Wedge is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2020/000556_9cf27a30e10680f0b6267055464df0ee_849ff737a108d63da5271e6e20904c7a. This device is marketed under the brand name Sigma PS. 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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