Omnia Medical PsiF DNA™ System

The Omnia Medical PsiF DNA™ System is a sacroiliac joint fusion device consisting of titanium alloy screws and washers used to treat degenerative sacroiliitis and sacroiliac joint disruptions. The screws are inserted through the ilium across the sacroiliac joint into the sacrum, with bone graft material placed in the implant barrel to promote bone incorporation. The system is available in non-sterile kits sterilized by the end user or sterile single-use kits.

The device uses Ti-6Al-4V ELI alloy screws per ASTM F3001 and washers per ASTM F136. It has one screw diameter with multiple length options to accommodate varying patient anatomy. Instrumentation is manufactured from surgical-grade stainless steel or aluminum. The device can be implanted via transverse or inline approach, with inline implantation requiring concurrent transverse screw placement.

ASTM F2193 (static and dynamic three-point bending), ASTM F543 (screw axial pullout, static driving torque, static torsion), ASTM F3574 (static and dynamic vertical shear). Mechanical testing methods, data, and cadaveric testing results were provided.

The subject device shares the same intended use (sacroiliac joint fusion) and fundamental scientific technology as the predicate SAIL Fusion BowTie™ SI Joint Fusion System. Comparative testing demonstrates no differences in technological characteristics that raise new safety or efficacy questions. The mechanical properties, materials, and device function are equivalent to the predicates, and no clinical testing was required because the mechanical data and comparable design support substantial equivalence.