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The CompresSURE System is indicated for fracture fixation where fracture compression is desired, and where insertion of the nut-and-bolt system does not increase the risk of morbidity due to the need for surgical access to both sides of the compressed area. The device may also be used when compression between separate bones is desired (i.e.- the syndesmosis) as long as there is not increased morbidity associated with the insertion of a nut-and-bolt system, as discussed above. The system is not intended for spinal use.

The U.S. Implants CompresSURE Fracture Repair System is a fracture fixation screw, washer, nut-and-bolt system for cortical wall compression of a bone fracture across the fracture site and, as well, provides an alternative to a cancellous bone screw for fracture fixation in the ankle, knee - proximal tibia, distal femoral, patella, etc.. The screw/bolt and nut is cannulated for use over a 1.6mm guide pin allowing for accurate placement of the screw/nut assembly in conjuction with use of fluoroscopic image x-ray. A full range of sizes are available from 25mm to 67mm in 3mm increments. The screw/bolt, washers, and nut are manufactured from High Strength 6-4 ELI Titanium Alloy with an Anodized surface. Cannulated drills, countersinks, depth gauge, and driver instruments are available for use in insertion of the screw, washer, bolt-and-nut system. Removal (when necessary) of the device is carried out percutaneously. Pull-out and bending strength testing according to ASTM F543 & F1264 show over 2 times the strength to conventional standard 4.0mm cannulated cancellous screws.