Knee Prosthesis - India CDSCO Medical Device Registration

Knee Prosthesis is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2023/001059_0055230526a4ba363ae7709222fc3cc4_531db5626e291df59a008fb64696d05c. This device is marketed under the brand name GENESIS II Patella. The license holder is Smith & Nephew Healthcare Pvt. Ltd, and it is classified as Device Class Class C. The approving authority is CDSCO.

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CDSCO Registered

Class Class C

Knee Prosthesis

UID: IMP/MD/2023/001059_0055230526a4ba363ae7709222fc3cc4_531db5626e291df59a008fb64696d05c

Brand Name

GENESIS II Patella

License Holder

Smith & Nephew Healthcare Pvt. Ltd

Device Class

Class C

Approving Authority

CDSCO

Product Information

The Genesis II XLPE Resurfacing Patellar Components are intended to be used with Smith & Nephew Total Knee Systems and their cleared Indications for Use. Indications for Total Knee Replacement - 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.