Total Knee Replacement System - India CDSCO Medical Device Registration

Total Knee Replacement System is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2020/000112_34c2e41e8e18584bcde6363d92a64ef3_f32254cf966bc991b4d6ab2abf9e2052. This device is marketed under the brand name Total Knee Replacement. The license holder is Stryker India 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 Replacement System

UID: IMP/MD/2020/000112_34c2e41e8e18584bcde6363d92a64ef3_f32254cf966bc991b4d6ab2abf9e2052

Brand Name

Total Knee Replacement

License Holder

Stryker India Pvt. Ltd.,

Device Class

Class C

Approving Authority

CDSCO

Product Information

Painful, disabling joint disease of the knee resulting from: noninflammatory degenerative joint disease (Total Knee Replacement), rheumatoid arthritis or post-traumatic arthritis. • Post-traumatic loss of knee joint configuration and function. • Moderate varus, valgus, or flexion deformity in which the ligamentous structures can be returned to adequate function and stability. • Revision of previous unsuccessful knee replacement or other procedure. • Fracture of the distal femur and/or proximal tibia that cannot be stabilized by standard fracture management techniques