CDSCO UID IMP/MD/2019/000456_adb7df7fd4f0b21b824d6830621ac1cc_00d03907b5b5a3ee656905afdf8a2672
Shoulder System
Zimmer India Private Limited·Device Class Class C·India CDSCO·Brand: Vanguard Knee System - tibial Component
Registration details
- UID
- IMP/MD/2019/000456_adb7df7fd4f0b21b824d6830621ac1cc_00d03907b5b5a3ee656905afdf8a2672
- Device class
- Class C
- Brand name
- Vanguard Knee System - tibial Component
- License holder
- Zimmer India Private Limited
- Approving authority
- CDSCO
- Product information
- Biomet Comprehensive Reverse Shoulder products are indicated for use in patients whose shoulder joint has a grossly deficient rotator cuff with severe arthropathy and/or previously failed shoulder joint replacement with a grossly deficient rotator cuff. The patient must be anatomically and structurally suited to receive the implants and a functional deltoid muscle is necessary. The Comprehensive Reverse Shoulder is indicated for primary, fracture, or revision total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency. Titanium glenospheres are intended for patients with Cobalt Alloy material sensitivity. The wear of these devices has not been tested but, based on pin on disk testing, the wear rate is inferior to that of cobalt alloy glenospheres. A Cobalt Alloy glenosphere is the recommended component for reverse shoulder arthroplasty patients without material sensitivity to cobalt alloy. Glenoid components with Hydroxyapatite (Vanguard Knee System - tibial Component) coating applied over the porous coating are indicated only for uncemented biological fixation applications. The Glenoid Baseplate components are intended for cementless application with the addition of screw fixation. Interlok® finish humeral stems are intended for cemented use and the MacroBond® coated humeral stems are intended for press-fit or cemented applications. Humeral components with porous coated surface coating are indicated for either cemented or uncemented biological fixation applications
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About this record
Shoulder System is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2019/000456_adb7df7fd4f0b21b824d6830621ac1cc_00d03907b5b5a3ee656905afdf8a2672. 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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