Hip Replacement Restoration Inserts - India CDSCO Medical Device Registration

Hip Replacement Restoration Inserts is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2019/000088_c178c36c883af4cf3a689b5c357223e2_dda8088f927215bcedd97916710b3dc7. 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

Hip Replacement Restoration Inserts

UID: IMP/MD/2019/000088_c178c36c883af4cf3a689b5c357223e2_dda8088f927215bcedd97916710b3dc7

Brand Name

Trident II Acetabular Component System

License Holder

Stryker India Pvt. Ltd.,

Device Class

Class C

Approving Authority

CDSCO

Product Information

The indications for use for total hip arthroplasty include: • Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis; • Rheumatoid arthritis; • Correction of functional deformity; • Revision procedures where other treatments or devices have failed; and, • Treatment of on-union, femoral neck and trochanteric fractures of the proximal femur with head • involvement that are unmanageable using other techniques. • Dislocation risks