NEO Pedicle Screw System™

The NEO Pedicle Screw System™ is a posterior spinal fixation system that provides immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion. It can be used for degenerative disc disease, spondylolisthesis, trauma, spinal stenosis, curvatures, tumor, pseudarthrosis, and failed previous fusion. When combined with BonOs® Inject bone cement, it restores spinal column integrity in advanced stage tumor patients with limited life expectancy who cannot achieve fusion.

The modified system consists of 27 pedicle screws (4.5–8.0 mm diameter), 8 iliac screws (8.0 and 10.0 mm diameter), titanium-alloy rods, and new axial connectors, all made from materials compliant with ASTM and ISO standards (Ti-6Al-4V ELI per ISO 5832-3 or ASTM F136, and CoCrMo per ISO 5832-12 or ASTM F1537). New additions include 10.0 mm diameter iliac screws, 150 mm connectors, and axial connectors; all components are MRI conditional.

Finite element analysis and mechanical testing per ASTM F1717 (dynamic compression and bending); magnetic field interactions ASTM F2052-15; MRI-related heating ASTM F2182-11a; artifacts ASTM F2119-07 (R2013); biological evaluation per ISO 10993-1 series; and compliance with the Spinal System 510(k) Guidance for Industry and FDA Staff (May 3, 2004).

The modified NEO system is substantially equivalent to its predicate (K222256) because it maintains identical intended use, materials, design principles, and mechanical function. Non-clinical testing demonstrates no new or worse-case mechanical performance for subject components; the new axial connector was validated in construct testing and confirmed to function as intended; the 10.0 mm iliac screws passed biological evaluation and sterilization validation; and MRI conditional status is retained. All changes represent optimization within the existing design envelope rather than fundamental modifications to safety or effectiveness.