CEMTIV Femoral stem - India CDSCO Medical Device Registration

Product Information

Hemi and total hip arthroplasties are indicated for the treatment of symptomatic pain and/or functional problems of the hip in patients whose skeleton is mature and only when pain killer medicamentation and correctly followed conservative treatment have failed. For the patient, their anatomy and the structure of their articulation will need to be adapted to receive the selected implant(NA). Indications for total or partial hip arthroplasty are: - Degenerative non inflammatory hip disease (NA). - Inflammatory hip disease (NA). - Metabolic hip disease (NA). - Post Traumatic degenerative arthritis. - Avascular necrosis. - Congenital dysplasia of the hip. - Functional repair of a recent trauma (NA) - Revision of a failed conservative surgery, osteosynthesis, partial or total arthroplasty. - Tumoral surgery when affecting the hip joint. The un-coated cementless sand-blasted variant of femoral stem is indicated only for the treatment of the femoral neck fracture at the elderly. According to this limit of indication, its benefit/risk ratio is estimated only in the short term. The recommended indications for dual mobility cup are: - Primary arthroplasties for patients at high risk of dislocation (NA), - Revision arthroplasties in cases of recurrent dislocations for patients at high risk of articular instability. The trochanteric grip plate is used in combination with the PRIUS stem and cortical screws Ø 4.5mm (NA) in case of: - Fractures of the trochanteric region following the implantation of a femoral stem, - Trochanterotomy for implantation or removal of a femoral stem (NA). Treatment of trochanter pseudarthrosis after primary prosthesis or revision prosthesis. In primary surgery of the hip joint, and even more in revision or tumoral surgery, the quality of the bone stock and the bone defects due to the ablation of any previously implanted material can compromise the primary fixation of the implantable device and thus limit its indications. Depending on the location and the extension of the bone defect, a longer cemented or cementless femoral component including a variety of complementary fixation means or an acetabular component including peripheral flanges and hooks can be considered