Orthex External Fixation System

The Orthex External Fixation System is an external fixator used to stabilize fractures, perform osteotomies, conduct foot arthrodesis, enable leg lengthening in pediatric and adult patients (ages 2–21), and correct bone deformities in the upper and lower extremities. It includes rings, partial rings, footplates, monolateral rails, hardware, tensioned wires, and half pins made from metal and plastic materials, plus an optional web-based Point and Click software to aid surgical planning.

The subject device has the same intended use, principle of operation, device classification, product code, sterilization, and packaging as the predicate Orthex External Fixation System (K223786). There are differences in materials, sizes, and design features, but performance testing confirmed these differences do not raise new safety or effectiveness questions.

Biocompatibility per ISO 10993-1; mechanical performance per ASTM F543 (self-taping, insertion torque, torsional strength) and ASTM F1541 (static and dynamic bending); hydroxyapatite coating per ASTM F1147, ISO 13779-2, ISO 13779-3, FTIR, and ASTM F1926/1926M.

The subject device is substantially equivalent because it shares the same intended use, classification, sterilization method, and fundamental technological characteristics as the predicate device. Although materials, sizes, and design features differ, performance testing data demonstrate that the subject device achieves equivalent or better performance, and these differences do not raise new or different questions of safety and effectiveness.