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The ChM 4.5mm Cortical screws are intended for fixation of various long bones, such as the humerus, femur and tibia. They are also for use in fixation of non-unions or malunions in adults and in both children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by screw fixation.

This Traditional 510(k) submission is being supplied to the U.S. FDA to seek clearance to market the new ChM 4.5mm Cortical screws. The ChM 4.5mm Cortical screws are single-use, stand alone, open reduction and internal fixation devices. They have self-tapping features, hexdrive head recess, and are manufactured from titanium alloy in accordance with ISO 5832-11/ ASTM F1295-16. The ChM 4.5mm Cortical screws are offered non-sterile only and are available in various lengths. The device is meant to be used as a load sharing device, and it may be removed once the fracture is healed. Implantation with use of cortical screws should be performed in the operating room conditions.