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/2018/000076_ed840676bf82becf25e74dd89cf95c2e_9f37af780e097a14c2786ceb1e1ebcf7. This device is marketed under the brand name JOURNEY. 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

Total Knee System

UID: IMP/MD/2018/000076_ed840676bf82becf25e74dd89cf95c2e_9f37af780e097a14c2786ceb1e1ebcf7

Brand Name

JOURNEY

License Holder

Smith & Nephew Healthcare Pvt. Ltd.

Device Class

Class C

Approving Authority

CDSCO

Product Information

Smith & Nephew ANTHEM Total Knee System is intended for cemented total knee arthroplasty (JOURNEY) in skeletally mature patients with the following indications. "• Rheumatoid arthritis. • Post-traumatic arthritis, osteoarthritis, or degenerative arthritis. •Posterior stabilized knee systems aredesigned for use in patients in primary surgery, where the anterior and posterior cruciate ligaments areincompetent, and the collateralligaments remain intact

Class C

Screws

Class C

Moisture Responsive Catheter Dressing

Brand: IV3000

Class B

Transparent dressing

Brand: IV3000

Class B