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CDSCO UID IMP/MD/2019/000456_fe2aab42d294ab713b1f6619411cb39d_66f5d97b4ae4737c38bab66a9fc5e5d6

Hip System

Zimmer India Private Limited·Device Class Class C·India CDSCO·Brand: Vanguard Knee System - tibial Component
Registration details
UID
IMP/MD/2019/000456_fe2aab42d294ab713b1f6619411cb39d_66f5d97b4ae4737c38bab66a9fc5e5d6
Device class
Class C
Brand name
Vanguard Knee System - tibial Component
License holder
Zimmer India Private Limited
Approving authority
CDSCO
Product information
Protrusio Cage and acetabular shell implants are intended for use in reconstruction of the hip joint due to disease, deformity or trauma. The devices are intended for general use in skeletally mature individuals undergoing primary and/or secondary revision surgery. The device is a single use implant. The Protrusio Cage is to be used in conjunction with any commercially available polyethylene acetabular cup. Shell components are to be used with Biomet Ringloc Acetabular Liners.,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

Hip System is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2019/000456_fe2aab42d294ab713b1f6619411cb39d_66f5d97b4ae4737c38bab66a9fc5e5d6. 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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