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_48b386dcf1c3bad9aab3591ea498a1d6. 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_48b386dcf1c3bad9aab3591ea498a1d6

Brand Name

Trident II Acetabular Component System

License Holder

Stryker India Pvt. Ltd.,

Device Class

Class C

Approving Authority

CDSCO

Product Information

Painful, disabling joint disease of the knee resulting from: degenerative arthritis, 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. Additional Indications for Posterior Stabilized Components: • Ligamentous instability requiring implant bearing surface geometries with increased constraint. • Absent or non-functioning posterior cruciate ligament. For TS Components Only: Severe anteroposterior and medial/lateral instability of the knee joint. Indications for Bone Augmentation: • Painful, disabling joint disease of the knee secondary to: degenerative arthritis, rheumatoid arthritis, or post-traumatic arthritis, complicated by the presence of bone loss. • Salvage of previous unsuccessful total knee replacement or other surgical procedure, accompanied by bone loss