Hip System - India CDSCO Medical Device Registration

Product Information

1. Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis. 2. Rheumatoid arthritis 3. Correction of functional deformity 4. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques. 5. Revision of previously failed total hip arthroplasty. The Echo Press-Fit Hip System is intended for uncemented use only. Polished Femoral Hip Prosthesis with Proximal Cement Spacer is intended for cemented use only and may be used in partial and total hip arthroplasties. The porous titanium augments are intended to provide the orthopedic surgeon with a prosthetic alternative to structural allograft in cases of segmental deficiencies. The porous titanium acetabular augment is affixed to the mating acetabular cup using bone cement. The assembled porous titanium augment/acetabular construct is intended for cemented or uncemented use. Porous coated devices are marketed for non-cemented use in the United States for skeletally mature patients undergoing primary hip replacement surgery as a result of non-inflammatory degenerative joint disease. 1. Fresh Fractures 2. Osteotomy 3. Revision procedures where other treatments or devices have failed. 4. Arthrodesis Patient selection factors to be considered include: 1) need for alignment and stabilization of bone fractures, 2) ability and willingness of the patient to follow postoperative care instructions until healing is complete, and 3) a good nutritional state of the patient