Restoration Hip replacement System - India CDSCO Medical Device Registration

Restoration Hip replacement System is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2019/000496_f2b275e5e37632346c885586e8610727_b5e064be2a67f847c7271d4adc5d5dd2. This device is marketed under the brand name Femoral Stems. The license holder is M/s Stryker India Private Ltd.,, and it is classified as Device Class Class C. The approving authority is CDSCO.

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CDSCO Registered

Class Class C

Restoration Hip replacement System

UID: IMP/MD/2019/000496_f2b275e5e37632346c885586e8610727_b5e064be2a67f847c7271d4adc5d5dd2

Brand Name

Femoral Stems

License Holder

M/s Stryker India Private Ltd.,

Device Class

Class C

Approving Authority

CDSCO

Product Information

he 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 non-union, femoral neck and trochanteric fractures of the proximal femur with head • involvement that are unmanageable using other techniques. • Dislocation risks