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The InteliFUSE, Inc. Warmsystem with StimuLinks is used as a system for the following indications: 1) hand and foot bone fragment and osteotomy fixation and joint arthrodesis. 2) fixation of proximal tibial metaphysis osteotomy. 3) fixation of soft tissue to bone such as anterior cruciate reconstruction. 4) fixation of maxillofacial and mandibulofacial fractures and osteotomies. 5) fixation of unloaded craniofacial bone fractures and craniostomies. The StimuLinks are contraindicated for craniofacial patients with a skull thickness less than the selected prong length. 6) adjunctive fixation of small bone fragments. These fragments may be located in long bones such as the femur, fibula and tibia in the lower extremities; the humerus, ulna or radius in the upper extremities; the clavicle and ribs; and in flat bones such as the pelvis, scapula and sternum

The InteliFUSE, Inc. StimuLinks are shape memory alloy staples available in various sizes and guages appropriate for the fixation of bone to bone or soft tissue to bone. The staples have prongs which are parallel during insertion. Application of heat from the Warmsystem Console, or from the portable InteliFUSER warming devices results in compression and retention of the staples. Accessories to the System include instruments for locating drill holes, gauging hole depth, and inserting and tamping the staples in place.

The InteliFUSE, Inc. Warm System with StimuLinks are used as a system for the following indications: 1) hand and foot bone fragment and osteotomy fixation and joint arthrodesis 2) fixation of proximal tibial metaphysis osteotomy 3) fixation of soft tissue to bone such as anterior cruciate reconstruction.

The system consists of two and four prong staples for use in various fixation techniques. The Nitinol staples have prongs which are parallel during insertion. Application of heat from the Warm System to the staple causes the prongs to deflect inward. This inward deflection results in staple compression and retention. The heat is applied through two electrodes in an autoclavable heating wire. The electrodes are applied to the back of the implanted staple to activate heating. An accessory pack is provided with the Warm System and includes the resterilizable current source, drill bits of different sizes for creating proper hole diameters, a drill guide for depth gauging, an impactor for tapping the staples in place, forceps, and a locator pin. The accessory pack components are all commercially available finished devices. The 2 prong StimuLink staples are available in wire thicknesses from 1.2 x 1.2 mm to 2mm x 3 mm, and in lengths and heights from 5 to 30 mm, including uneven prong heights. Four prong plates for multiaxial loads are available in ranges from 15 x 6 x 6 mm to 15 x 6 x 10 mm.