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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 subject devices, Biomet Answer/Impact/Integral Distal Centralizer/Centering Sleeves, are cylindrical components designed to slide onto the distal end of a cemented femoral stem prior to insertion into the femoral canal. This submission proposes a new bioburden reduction manufacturing process that includes a new contact material for the Biomet Answer/Impact/Integral Distal Centralizer/Centering Sleeve.

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 subject devices, Distal Centralizers, are cylindrical components designed to slide onto the distal end of a cemented femoral stem prior to insertion into the femoral canal.

The Exeter® V40™ Femoral Stem Hip System is intended for use in total or hemi hip replacement. It is intended for cemented use only. The Exeter® V40TM Femoral Stem Hip System is indicated for: · noninflammatory degenerative joint disease, including osteoarthritis and avascular necrosis; - · rheumatoid arthritis: - · correction of functional deformity; · revision procedures where other treatments or devices have failed; and, · treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.

The Exeter® V40™ Femoral Stems/Orthinox Femoral Heads are sterile, single-use components intended for cemented total and hemi-hip arthroplasty. The femoral stems have a tapered distal portion with a V40™ neck taper. The stems are available in various offsets and body sizer. The Exeter Hip System continues to be manufactured from the same materials, the same design and the same manufacturing process as the previously cleared Exeter® V40™ femoral stems.

- 1. Joint impairment from arthritis (rheumatoid, osteo and post traumatic). - 2. Revision of failed femoral head replacements. - 3. When alternative reconstructive techniques are not viable. - 4. . When arthrodesis is contraindicated. - 5. Avascular necrosis or fracture of the femoral head. - 6. Congenital defects that will allow adequate function of the system.

Progeny Forged CoCr Cemented Femoral Component

Relief of pain and restoration of hip function following the effects of osteo, theumatoid and inflammatory arthritis, post-trauma disease, avascular necrosis, and total hip revision. These femoral stems are intended for use with bone cement.

The Taper-Fit Total Hip System consists of 4 sizes of stem. For each stem size there are 2 offsets 38 mm & 45 mm. A CDH stem is also available with a 36 mm offset. The modular stem is manufactured from Stainless Steel in accordance with BS 7251 Pt 9 -Specification for High Nitrogen Stainless Steel and is provided with a Polymethylmethacrylate Stem Centralizer. The devices are used to resurface femoral hip joints and reinstate function following the degenerative effects of osteo and theumatoid arthritis, post trauma disease, avascular neurosis and septic/aseptic total hip revision. The stem is double tapered, collarless and highly polished. The stem is used with a 316L Stainless Steel Modular Head. This stainless steel complying to BS 7252 Pt 1: 1997, ISO 5832-1:1997 Metallic Materials for Surgical Implants, Part 1. Specification for Wrought Stainless Steel.

The Exactech AuRA Calcar Replacement Femoral Stem is indicated for use in skeletally mature patients in whom the calcar region is missing due to a failed previous total hip replacement as a result of osteoarthritis, osteonecrosis , rheumatoid arthritis or congenital hip dysplasia. It is also potentially indicated for use in post-traumatic degenerative problems. FOR CEMENTED USE ONLY

The collar of the calcar replacement stem differentiates itself from all other cemented femoral components in that it provides a horizontal and vertical collar type platform for the best load transfer in a compromised femoral situation. A cemented primary or long stem device typically has a collar designed at some angle to the femoral centerline whereby a bone loading platform can be established at the optimum resection location. In many instances, this ideal position has been compromised and an implant surface that is horizontally perpendicular to and vertically parallel to the femoral centerline is preferred for optimal axial load transfer to the bone and appropriate trochanteric fixation can be achieved. The surface finish is dominated by an overall satin, glass bead blast everywhere except on the taper. A secondary grit blast is performed on portions of the proximal region of the implant. A complete instrumentation and trial system is available to assist in accurate implantation of the AuRATM Calcar Replacement Femoral Stem.