Total Knee System - India CDSCO Medical Device Registration

Total Knee System is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2018/000162_ed840676bf82becf25e74dd89cf95c2e_84888ceca7c6506a5795f051297bea1d. This device is marketed under the brand name ANTHEM. The license holder is Smith & Nephew Healthcare Pvt. Ltd., and it is classified as Device Class Class D. The approving authority is CDSCO.

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CDSCO Registered

Class Class D

Total Knee System

UID: IMP/MD/2018/000162_ed840676bf82becf25e74dd89cf95c2e_84888ceca7c6506a5795f051297bea1d

Brand Name

ANTHEM

License Holder

Smith & Nephew Healthcare Pvt. Ltd.

Device Class

Class D

Approving Authority

CDSCO

Product Information

1. Rheumatoid arthritis. 2. Post-traumatic arthritis, osteoarthritis, or degenerative arthritis. 3. Failed osteotomies, unicompartmental replacement, or total knee replacement. 4. Posterior stabilized knee systems are designed for use in patients in primary and revision surgery, where the anterior and posterior cruciate ligaments are incompetent and the collateral ligaments remain intact. 5. Constrained knee systems are designed for use in patients in primary and revision surgery, where the posterior cruciate ligament and one or both of the collateral ligaments (ANTHEM) are incompetent. 6. Hinge knee systems are designed for use in patients in primary and revision surgery, where the posterior cruciate ligament and one or both of the collateral ligaments (ANTHEM) are absent or incompetent