Knee Replacement System-Femoral
- UID
- IMP/MD/2020/000556_ea8ef357146176f952d311ecdb7ac72b_5f5660686c327a455b01a7725c7672e1
- Device class
- Class D
- Brand name
- Sigma PS
- License holder
- Johnson & Johnson Private Limited
- Approving authority
- CDSCO
- Product information
- The DePuy SIGMA High Performance Partial Knee System is intended to provide increased patient mobility and reduced pain by replacing the damaged knee joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components. INDICATION The SIGMA High Performance Partial Knee System is indicated for single compartmental knee replacement in skeletally mature individuals withosteoarthritis, post-traumatic arthritis of the tibiofemoral surfaces or a history ofgout or pseudogout. All components are intended for CEMENTED USE ONLY. Updation of IFU including Indications and Contraindications
Knee Replacement System-Femoral is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2020/000556_ea8ef357146176f952d311ecdb7ac72b_5f5660686c327a455b01a7725c7672e1. 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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