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 procedures where other treatment or devices have failed. 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.,knee system(Vanguard Knee System - tibial Component)-1. 1. Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, and/or traumatic arthritis where one or more compartments are involved. 2. 2. Correction of varus, valgus, or posttraumatic deformity 3. 3. Correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure The Regenerex femoral augments are indicated for use with the Vanguard Total Knee System. The Regenerex tibial augments are indicated for use with standard and offset Biomet Tibial Trays. Femoral components and tibial tray components with porous coatings are indicated for cemented and uncemented biological fixation application. Non-coated (Vanguard Knee System - tibial Component) devices and all-polyethylene patellar components are indicated for cemented application only. 4. Regenerex components* are intended only for uncemented biologic fixation application. The Vanguard DA 360 components are not intended for use with the Vanguard PS Open Box Porous Femoral Components. The Vanguard DA 360 components are not approved for sale in the United States or Canada