Hip System - India CDSCO Medical Device Registration

Product Information

A. This device is indicated for total hip replacement for the following: severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head, non-union of previous fractures of the femur; congenital hip dysplasia, protrusio acetabuli, slipped capital femoral epiphysis; disability due to previous fusion; previously failed endoprostheses, and/or total hip components in the affected extremity and acute femoral neck fractures. Hemi-hip replacement for the following: fracture dislocation of the hip; elderly, debilitated patients when a total hip replacement is contraindicated; irreducible fractures in which adequate fixation cannot be obtained; certain high sub capital fractures and comminuted femoral neck fractures in the aged; non-union of femoral neck fractures; secondary avascular necrosis of the femoral head; pathological fractures of the femoral neck; and osteoarthritis in which the femoral head is primarily affected.,knee system(Coonrad/ Morrey Total Elbow - Ulnar Component)-The device indications are the following: • Osteoarthritis, traumatic arthritis, polyarthritis, and/or severe chondrocalcinosis of the patellofemoral joint. • The salvage of previously failed surgical attempts (Coonrad/ Morrey Total Elbow - Ulnar Component). • History of patellar dislocation or patella fracture. • Dysplasia-induced degeneration. • This device is intended for cemented use only