Virata Spinal Fixation System

The Virata Spinal Fixation System is a pedicle screw-based spinal fixation system designed to provide immobilization and stabilization of thoracic, lumbar, and sacral spine segments in skeletally mature patients as an adjunct to fusion. It uses modular and preassembled titanium alloy or cobalt chrome screws, rods in various configurations, and set screws that connect across multiple vertebral levels. The system also includes navigated instruments for use with the Medtronic StealthStation system to assist in precise screw placement during open or minimally invasive surgery.

The Virata system is identical or similar to predicate devices (primarily the SeaSpine Mariner Pedicle Screw System K222110) in components, design, materials, manufacturing, and operating principle. The system utilizes modular and preassembled screw configurations available in solid and cannulated versions with various sizes, rods in multiple lengths and diameters, and compatibility with Mariner and Malibu rod and connector components. Implants are manufactured from titanium alloy Ti-6Al-4V ELI (ASTM F136) and cobalt chrome alloy (Co-28Cr-6Mo per ASTM F1537).

ASTM F1717 (Dynamic Compression Bending, Static Compression Bending, Static Torsion), ASTM F1798 (Static Anterior-Posterior Load testing at standard and maximum angle configurations).

The Virata system is substantially equivalent to predicate devices because it is identical in technological characteristics, intended use, indications, materials, design, and manufacturing principles to legally marketed predicates, particularly the SeaSpine Mariner system. Mechanical performance testing using established ASTM standards demonstrates comparable safety and biomechanical compatibility. The device achieves the same intended purpose of spinal immobilization and stabilization through substantially the same mechanism of action without presenting new or different risks.