XT3 System; XT3 System, Mini; XT3 System, 40mm; XT3 System, Mini, 40mm

The XT3 System is an external fixation system for treating complex orthopedic conditions in adults. It is indicated for fracture fixation, nonunion, transverse bone transport of the tibia, and correction of bony or soft tissue defects or deformities. The system uses percutaneous fixation elements (half pins) and an external mechanical frame to stabilize and position bone segments.

The XT3 System employs an external fixation frame mechanically fixed to bone using half pins and other fixation elements. Components are manufactured from surgical-grade stainless steel and anodized aluminum alloys. Implantable components are supplied sterile; instruments and fixator assemblies are non-sterile and require end-user steam sterilization. The system operates through mechanical adjustment of fixation components with no new technological characteristics introduced in this submission.

Non-clinical testing was conducted per ASTM F1541 (Standard Specification and Test Methods for External Skeletal Fixation Devices), evaluating mechanical performance under axial compression, four-point bending, and torsional loading. Analytical evaluation referenced FDA's Orthopedic Non-Spinal Metallic Bone Screws and Washers performance criteria. Cadaveric evaluations were also performed to demonstrate clinical applicability.

The XT3 System is substantially equivalent to the primary predicate XT3 System (K241357) because it maintains identical fundamental external fixation principles and technological characteristics. The expanded indications to explicitly include nonunion and soft tissue defect correction do not constitute new intended use but rather established applications of external fixation consistent with the predicate and with other cleared devices like Orthofix Truelok Elevate (K242861). Performance testing demonstrates equivalent safety and mechanical performance.