ARTFX Trauma Bone Plate and Screw System

The ARTFX Trauma Bone Plate and Screw System is a titanium bone fixation device used to treat fractures, fusions, osteotomies, non-unions, malunions, and reconstructions across the upper extremity, lower extremity, pelvis, and clavicle. The system comprises four sub-systems (3.5, 4.5, Mini-Plate, and Bone Screw) that provide stability and alignment of bone fragments during healing, with a key feature being free choice of screw placement (locking or non-locking) in any plate hole.

The subject and predicate devices are similar in geometry, intended and indicated uses, materials (titanium Ti6Al4V-ELI per ASTM F136), sterilization methods (steam sterilization), and non-clinical performance. The devices are supplied non-sterile and designed for contoured anatomical locations with various plate thicknesses (0.8–5.5 mm) and screw diameters (1.5–7.3 mm).

Non-clinical performance testing was performed according to ASTM F382-17 and ASTM F543-23, and meets FDA guidance criteria for orthopedic non-spinal metallic bone screws and washers, and for orthopedic fracture fixation plates (Performance Criteria for Safety and Performance Based Pathway).

The device is substantially equivalent because it uses identical material formulation, processing, sterilization, and geometry to the reference device K212220 (ARTFX Spinal Fixation System) with no added chemicals. Each sub-system aligns with established predicate devices (Nebula, GREENS, SurgTech, Tandry, and NEOFIX systems) that share the same intended uses, compression and locking screw mechanisms, and performance characteristics demonstrated through equivalent non-clinical testing.