Total Hip replacement system - India CDSCO Medical Device Registration

Total Hip replacement system is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2019/000088_c0aa1ca53a245f19a42149602a09a398_a519a3bbd40b1ed2f4002ec2f2250d46. 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 Hip replacement system

UID: IMP/MD/2019/000088_c0aa1ca53a245f19a42149602a09a398_a519a3bbd40b1ed2f4002ec2f2250d46

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 hip resulting from: degenerative arthritis, rheumatoid arthritis, posttraumatic arthritis or late stage avascular necrosis. • Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other procedure. • Clinical management problems where arthrodesis or alternative reconstructive techniques are less likely to achieve satisfactory results. • Where bone stock is of poor quality or is inadequate for other reconstructive techniques as indicated by deficiencies of the acetabulum.