DYNAMIS™ Implant System

The DYNAMIS™ Implant System is a sacroiliac joint fusion device consisting of threaded, fenestrated, cannulated, 3D-printed titanium alloy implants and associated instruments. It is indicated for sacroiliac joint fusion in cases of joint dysfunction, disruption, and degenerative sacroiliitis, as well as for pelvic fracture fixation. Two or more implants are inserted across the sacroiliac joint to provide stabilization and fusion while allowing packing of bone graft materials.

The system features fully threaded, lag-design cannulated implants in multiple diameters and lengths, manufactured from medical-grade titanium alloy (Ti-6Al-4V ELI per ASTM F3001). A key distinguishing feature is the DYNAMIS™ TRU-NANO Screw variant, which incorporates a micro- and nano-roughened surface with electrochemically treated nanotube arrays (pore diameter 30–97 nanometers) incorporating calcium and phosphate, designed to promote osteoblast and mesenchymal stem cell mineralization.

Testing was conducted per ASTM F3574 (static and dynamic cantilever bending), ASTM F543 (static axial pullout, static torsion, and driving torque), and AAMI ST72:2011 (bacterial endotoxin testing). In vitro evaluations quantitated extracellular matrix mineralization by osteoblasts and mesenchymal stem cells on titanium alloy substrates.

The device is substantially equivalent because it shares the same intended use (sacroiliac joint fusion and pelvic fracture fixation), similar design (threaded metallic fasteners for bone fixation), comparable materials (titanium alloy), and equivalent function to the predicate devices. Performance testing demonstrates mechanical equivalence in strength and integrity. The nanotextured surface modification, while novel, does not alter the fundamental predicate function but rather enhances it through proven biological mechanisms without changing the device's classification or use.