LEO Spinal System

The LEO Spinal System is a surgical fixation device for the noncervical spine used as a posterior pedicle and non-pedicle fixation system. It serves as an adjunct to fusion with autograft or allograft in skeletally mature patients for treating conditions including degenerative disc disease, spondylolisthesis, trauma, spinal stenosis, deformities, tumor, pseudoarthrosis, and failed previous fusion.

The system consists of rods (5.5mm, 6.0mm, and 6.35mm diameters), pedicle screws (fixed angle, fixed angle reduction, multi-axial, and multi-axial reduction variants), crosslinks, set screws, hooks, and connectors. All components are made from titanium alloy (Ti6Al4V) per ISO 5832-3 and can be rigidly locked into various configurations. Devices are provided non-sterile for single use and require hospital sterilization via autoclave to SAL 10⁻⁶.

ASTM F1717-21 (static axial compression bending, dynamic compression bending, static torsional testing); ISO 17665-1 (sterilization validation); ISO 10993-1, 10993-5, 10993-10, 10993-23, 10993-11, 10993-18, and 10993-17 (biocompatibility testing including cytotoxicity, sensitization, reactivity, pyrogen, chemical characterization, and toxicological risk assessment).

The LEO Spinal System is substantially equivalent to predicate devices (Stryker XIA® 3 Spinal System and Medtronic CD HORIZON Legacy Spinal System) based on identical indications for use, materials, design, and function as a thoracolumbosacral pedicle screw system. Non-clinical testing demonstrates equivalent performance and biological safety with no animal or clinical studies required given the substantial equivalence determination.