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The MAC External Fixation System is a unilateral external fixation device intended for use in children and adults in the treatment of bone conditions including leg lengthening, osteotomies, arthrodesis, fracture fixation, and other bone conditions amenable to treatment by use of the external fixation modality. The addition of the MAC Male Adapter does not change the indications for use for the MAC External Fixation System.

The purpose of this submission is to add a Male Adapter Assembly to the previously cleared MAC External Fixation System. The subject MAC Male Adapter Assembly is intended to attach to the existing MAC Module), and allows the MAC to connect to other external fixation components, including: Construx Female Telescoping Arm, Carbon T-clamp, the DFS Angular Hinge and the Carbon Ankle component. These connections allow the surgeon to treat a variety of bone conditions amenable to treatment by use of the external fixation modality.