CDSCO UID IMP/MD/2019/000456_0fd2ba5dabd0832843ccf85d9aeffc94_8e655899310a66f88c211bc4de2a47af
Knee System
Zimmer India Private Limited·Device Class Class C·India CDSCO·Brand: Vanguard Knee System - tibial Component
Registration details
- UID
- IMP/MD/2019/000456_0fd2ba5dabd0832843ccf85d9aeffc94_8e655899310a66f88c211bc4de2a47af
- Device class
- Class C
- Brand name
- Vanguard Knee System - tibial Component
- License holder
- Zimmer India Private Limited
- Approving authority
- CDSCO
- Product information
- 1. 1. Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, and/or traumatic arthritis where one or more compartments are involved. 2. 2. Correction of varus, valgus, or posttraumatic deformity 3. 3. Correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure The Regenerex femoral augments are indicated for use with the Vanguard Total Knee System. The Regenerex tibial augments are indicated for use with standard and offset Biomet Tibial Trays. Femoral components and tibial tray components with porous coatings are indicated for cemented and uncemented biological fixation application. Non-coated (Vanguard Knee System - tibial Component) devices and all-polyethylene patellar components are indicated for cemented application only. 4. Regenerex components* are intended only for uncemented biologic fixation application. The Vanguard DA 360 components are not intended for use with the Vanguard PS Open Box Porous Femoral Components. The Vanguard DA 360 components are not approved for sale in the United States or Canada. ,knee system(Vanguard Knee System - tibial Component)-6. 1. Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, and/or traumatic arthritis where one or more compartments are involved. 7. 2. Correction of varus, valgus, or posttraumatic deformity 8. 3. Correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure The Regenerex femoral augments are indicated for use with the Vanguard Total Knee System. The Regenerex tibial augments are indicated for use with standard and offset Biomet Tibial Trays. Femoral components and tibial tray components with porous coatings are indicated for cemented and uncemented biological fixation application. Non-coated (Vanguard Knee System - tibial Component) devices and all-polyethylene patellar components are indicated for cemented application only. 9. Regenerex components* are intended only for uncemented biologic fixation application
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About this record
Knee System is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2019/000456_0fd2ba5dabd0832843ccf85d9aeffc94_8e655899310a66f88c211bc4de2a47af. This device is marketed under the brand name Vanguard Knee System - tibial Component. The license holder is Zimmer India Private Limited, and it is classified as Device Class Class C. The approving authority is CDSCO.
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