CDSCO UID IMP/MD/2019/000088_c0aa1ca53a245f19a42149602a09a398_8d2bf54101301ca4399e7edd0c82e1a0
Total Hip replacement system
Stryker India Pvt. Ltd.,·Device Class Class C·India CDSCO·Brand: Trident II Acetabular Component System
Registration details
- UID
- IMP/MD/2019/000088_c0aa1ca53a245f19a42149602a09a398_8d2bf54101301ca4399e7edd0c82e1a0
- Device class
- Class C
- Brand name
- Trident II Acetabular Component System
- License holder
- Stryker India Pvt. Ltd.,
- 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 When used with MDM Liners • Treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques. • Dislocation risks When used with Constrained Liners • The TRIDENT Constrained Acetabular Insert is indicated for use in primary and revision patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, joint or soft tissue laxity, neuromuscular disease, or intraoperative instability. The TRIDENT II Acetabular Shells are indicated for cementless use only
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About this record
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_8d2bf54101301ca4399e7edd0c82e1a0. 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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