OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation System

The OLYMPIC Posterior Spinal Fixation System and MASADA Modular Spinal Fixation System are thoracolumbosacral pedicle screw systems intended for immobilization and stabilization of the posterior, non-cervical spine in skeletally mature patients as an adjunct to fusion. They treat degenerative disc disease, spondylolisthesis, trauma, spinal stenosis, curvatures, tumors, pseudoarthrosis, and failed previous fusion. Both systems include pedicle screws, rods, sublaminar bands, S2AI screws for sacroiliac joint fusion, and navigated instruments for surgical placement.

The S2AI bone screw implants are made from titanium alloy (Ti-6Al-4V-ELI), CP titanium, or cobalt chrome alloy, designed to provide sacroiliac joint fusion in sacral alar iliac trajectories and connect to modular 5.5mm or 6.0mm diameter spinal fixation rods. The systems feature polyaxial and monoaxial screws, cross connectors, rod connectors, hooks, and navigated instruments for use with the Medtronic StealthStation System for stereotactic guidance in open and minimally invasive procedures.

ASTM F136 (Ti-6Al-4V-ELI), ASTM F67 (CP Titanium Grade 4), ASTM F1537 (CoCrMo alloy), ASTM F1058 (Elgiloy CoCrNi alloy), ASTM F2063 (Nitinol), ISO 10993 (PET); mechanical testing per ASTM F543 (torsional properties, driving torque, axial pullout strength), ASTM F2193 (static and dynamic bending), and ASTM F2129 (pitting corrosion).

The addition of S2AI screws to the OLYMPIC and MASADA systems is substantially equivalent to predicate devices (MASADA K231694, OLYMPIC K182239, SI-Bone K222774, Reunion K232211) based on similarities in intended use, design principles, materials, mechanical safety, and performance. No clinical studies were performed, relying on non-clinical testing demonstrating equivalent mechanical properties and corrosion resistance.