Total Hip System - India CDSCO Medical Device Registration
Total Hip System is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2022/000052_08226695ea318b8832570f14edad039e_80bb7a80f989858dfb6c971456979b76. This device is marketed under the brand name Consensus Hip System/ Unisys Hip System/ TaperSet Hip System. The license holder is MARS MEDICAL DEVICES LIMITED, and it is classified as Device Class Class D. The approving authority is CDSCO.
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Brand Name
Consensus Hip System/ Unisys Hip System/ TaperSet Hip System
License Holder
MARS MEDICAL DEVICES LIMITEDDevice Class
Approving Authority
CDSCO
Product Information
a) Primary replacement of the femoral head and neck with very little if any acetabular degradation noted. b) Rheumatoid, osteo, and post traumatic arthritis. c) Proximal femoral fractures. d) Avascular necrosis of the femoral head. e) Non-unions of proximal femoral neck fractures. f) Treatment of malunion or nonunion acetabular fractures. g) Significantly impaired joints resulting from rheumatoid, osteo, and post-traumatic arthritis. h) Revision of failed femoral head replacement, hip arthroplasty or other hip procedures. i) Other indications such as congenital dysplasia, arthrodesis conversion, coxa magna, coxa plana, coxa vara, coxa valga, developmental conditions, metabolic and tumorous conditions, osteomalacia, pseudarthrosis conversion, and structural abnormalities. j) Fractures of the proximal femur; k) Nonunions of proximal femoral neck fractures; l) Aseptic necrosis of the femoral head; m) Osteo-rheumatoid and post-traumatic arthritis of the hip with minimal distortion of the acetabulum; n) Salvage of failed total hip arthroplasty.
Total Hip System
Brand: REFLECTION
Smith & Nephew Healthcare Pvt. Ltd.
Total Hip System
Brand: REFLECTION
Smith & Nephew Healthcare Pvt. Ltd.
Total Hip System
Brand: Profemur, Profemur Gladiator Classic, Profemur TL Classic, Procotyl L, Dynasty, Cancellous Bone Screw, Rim-Lock "A-CLASSยฎ" Acetabular Poly Liner, Femoral Head Biolox Delta Ceramic/ Rim-Lock Biolox Delta Ceramic Liner, CoCr Femoral Head
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Total Hip System
Brand: REFLECTION
Smith & Nephew Healthcare Pvt. Ltd.

