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/2019/000088_34c2e41e8e18584bcde6363d92a64ef3_26606ed08d48a4911912f7047fd3c1ba. This device is marketed under the brand name Trident II Acetabular Component System. 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/2019/000088_34c2e41e8e18584bcde6363d92a64ef3_26606ed08d48a4911912f7047fd3c1ba

Brand Name

Trident II Acetabular Component System

License Holder

Stryker India Pvt. Ltd.,

Device Class

Class C

Approving Authority

CDSCO

Product Information

General Total Knee Arthroplasty (Trident II Acetabular Component System) Indications: • Painful, disabling joint disease of the knee resulting from: noninflammatory degenerative joint disease (Trident II Acetabular Component System), rheumatoid arthritis or post-traumatic arthritis. • Posttraumatic 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. Additional Indications for Cone Augments • Severe degeneration or trauma requiring extensive resection and replacement • Femoral and tibial bone voids • Metaphyseal reconstruction The Triathlon Tritanium® Cone Augment components are intended for cemented or cementless use