OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation System

The OLYMPIC and MASADA Posterior Spinal Fixation Systems are surgical devices used to immobilize and stabilize the spine during fusion procedures. They include pedicle screws, rods, connectors, and supporting instruments for treating degenerative disc disease, scoliosis, trauma, and other spinal conditions in both adult and pediatric patients. Both systems also feature fenestrated (hollow) screws that can be augmented with bone cement for tumor patients.

Both systems are top-loading thoracolumbar fixation systems composed of polyaxial screws, monoaxial screws, rods, and connectors manufactured from titanium alloys, cobalt-chromium alloys, and nitinol. The MASADA system is modular and designed for percutaneous and minimally invasive access, while the OLYMPIC system uses preassembled components. Key addition is the fenestrated screw design compatible with bone cements (G21 V-STEADY, G21 V-FAST, Teknimed F20, Teknimed HIGH V+).

ASTM F1717 (static and dynamic compression bending, static torsion), ASTM F543 (torsional yield, removal torque, axial pullout), and bone cement injection testing.

Astura Medical claims substantial equivalence based on the devices' similarities to predicate devices in principles of operation, technology, materials, and indications for use. The addition of fenestrated screws to existing OLYMPIC and MASADA systems follows the same design and material specifications as predicate fenestrated screw systems, with comparable mechanical performance demonstrated through standardized testing.