DYNAMIS™ SI Screw System

The DYNAMIS™ SI Screw System is a sacroiliac joint fusion device consisting of threaded, fenestrated, cannulated, 3D-printed titanium alloy implants with associated instruments. It is indicated for sacroiliac joint dysfunction, degenerative sacroiliitis, augmentation of sacropelvic fixation in lumbar/thoracolumbar fusion, and pelvic fracture fixation in skeletally mature patients.

The device features fully threaded implants with lag design, cannulated central threaded bodies that accommodate autograft and allograft packing, multiple diameter and length offerings for varying patient anatomy, and 3D-printed construction from medical-grade titanium alloy (Ti-6Al-4V ELI per ASTM F3001). Two or more implants are inserted across the SI joint to apply compressive force and provide stabilization.

Static cantilever bending and dynamic cantilever bending per ASTM F3574; static axial pullout, static torsion, and driving torque per ASTM F543.

The DYNAMIS™ SI Screw System is substantially equivalent to predicate devices (SI-BONE iFuse TORQ®, Curiteva, and Genesys Spine systems) because it shares identical indications for use, similar threaded metallic bone fixation fastener design and materials, equivalent function in providing sacroiliac joint fusion and stabilization, and comparable performance characteristics as demonstrated by meeting the same ASTM mechanical testing standards for bending, pullout, torsion, and driving torque.