A8 INTEGR8™ Porous Pedicle Screws

The A8 INTEGR8™ Porous Pedicle Screw System is a spinal fixation device consisting of additively manufactured pedicle screws and machined rods, tulips, and accessories. It is intended to immobilize and stabilize spinal segments in skeletally mature and pediatric patients as an adjunct to fusion, treating conditions such as degenerative disc disease, spondylolisthesis, trauma, spinal stenosis, deformities, tumors, pseudoarthrosis, and failed previous fusions in the thoracic, lumbar, and sacral spine.

The subject device uses additively manufactured (AM) Ti-6Al-4V ELI pedicle screw shafts per ASTM F3001, whereas predicate devices use subtractive machined screws. The device features Gaussian topography (controlled three-dimensional surface architecture) but does not meet FDA's regulatory definition of a porous coating. All other components—tulips, saddles, locking rings, and rods (Ti-6Al-4V ELI or Co-28Cr-6Mo)—are machined and identical to predicates.

ASTM F1717-21 (static and dynamic compression bending, static torsion), ASTM F2193-20 (static and dynamic testing), ASTM F1798-21 (static and dynamic testing), ASTM F543-17 (screw strength and pullout tests), and Finite Element Analysis per ASTM F2193.

The subject and predicate devices share identical indications for use, materials of manufacture, structural support mechanism, and component sizes. Although the subject device uses additively manufactured screws while predicates use machined screws, mechanical testing demonstrates the AM screws have substantially equivalent strength and performance to subtractive machined predicate screws, and the technological difference raises no new safety or effectiveness concerns.