Hip System - India CDSCO Medical Device Registration

Product Information

INTENDED USE – TOTAL HIP PROSTHESIS Total hip arthroplasty is intended to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components. INDICATIONS – TOTAL HIP PROSTHESIS Total hip replacement is indicated in the following conditions: 1. A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis, or congenital hip dysplasia. 2. Avascular necrosis of the femoral head. 3. Acute traumatic fracture of the femoral head or neck. 4. Failed previous hip surgery including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement. 5. Certain cases of ankylosis. Porous-coated Pinnacle Acetabular Cups are indicated for cementless applications. SELF-CENTERING Hip Prostheses and Hemi-Hip Prostheses are intended to be used for hemi-hip arthroplasty where there is evidence of a satisfactory natural acetabulum and sufficient femoral bone to seat and support the femoral stem. Hemi-hip arthroplasty is indicated in the following conditions: 1. Acute fracture of the femoral head or neck that cannot be appropriately reduced and treated with internal fixation. 2. Fracture dislocation of the hip that cannot be appropriately reduced and treated with internal fixation. 3. Avascular necrosis of the femoral head. 4. Non-union of femoral neck fractures. 5. Certain high subcapital and femoral neck fractures in the elderly. 6. Degenerative arthritis involving only the femoral head in which the acetabulum does not require replacement. 7. Pathology involving only the femoral head/neck and/or proximal femur that can be adequately treated by hemi-hip arthroplasty. Total or hemi-hip arthroplasty may be considered for younger patients if, in the opinion of the surgeon, an unequivocal indication for hemi-hip replacement outweighs the risks associated with the age of the patient and if limited demands regarding activity and hip joint loading can be assured.