DYNEX® External Fixation Systems

The DYNEX® External Fixation Systems are metallic bone fixation devices intended for external fixation to stabilize fractures, perform osteotomy, arthrodesis, and leg lengthening in both adults and pediatric patients. The systems include rings, rails, pins, wires, and instruments to construct external fixation frames attached to bone. The DYNEX TRIAD - TTT Fixation System is specifically designed for treating non-union or pseudoarthrosis of long bones via tibial bone transport.

The DYNEX TRIAD - TTT Fixation System adds a new fixation frame, transport pins, and instruments as a line extension to the existing DYNEX External Fixation Systems. The fixation frame includes a linear bone adjustment mechanism allowing up to 10mm of transverse bone transport. The frame is composed of similar materials as the predicate devices' half pins and includes similar instruments and accessories.

Static Axial Strength per ASTM F1541-24; Slipping Torque per ASTM F1541-24; Four-Point Bending per ASTM F1541-24; Torsional Strength per ASTM F1541-24; Steam Sterilization and Reprocessing Adsorption Analysis; Biological Evaluation per FDA Guidance of ISO 10993-1:2018.

The subject device is substantially equivalent because it has the same intended use as the predicates (external fixation) and performs the same function with no change in intended use. The technological differences (addition of a new fixation frame and transport mechanism) are not significant enough to alter the device's safety or effectiveness. Non-clinical testing demonstrated the subject device meets all acceptance criteria and is as safe and effective as the predicate devices.