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The KMedic External Fixation Devices are non-sterile, single-use, external fixation devices intended to be used for unilateral external fixation in the treatment of bone conditions including limb lengthening, osteotomies, arthrodesis, fracture fixation and other bone conditions amenable to treatment by use of the external fixation modality.

KMedic External Fixation Devices consist of various fixation pins and wires for use in unilateral external fixation. The various lengths, sizes and end configurations are offered to accommodate various patient anatomies, injuries and/or conditions, and physician preference. All KMedic external fixation devices included in this submission are manufactured of medical grade stainless steel. All KMedic external fixation devices included in this submission will be offered in a non-sterile condition. The following KMedic External Fixation Devices are included in this submission: Kirschner Wires, Steinmann Pins, Schanz Pins, Cerclage Wires.