Tiger 2 System

The Tiger 2 System is a pedicle screw fixation system for spinal stabilization in skeletally mature patients. It provides immobilization and stabilization of thoracic, lumbar, and sacral spine segments as an adjunct to fusion, treating conditions including degenerative spondylolisthesis, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion. A fenestrated variant is intended for use with saline and radiopaque dye.

The Tiger 2 System employs the same rod-based fixation design as the predicate, featuring polyaxial pedicle screws with variable screw and rod diameters and lengths. Components are manufactured from titanium alloy (Ti-6Al-4V per ASTM F136) and cobalt chrome alloy (Co-28Cr-6Mo per ASTM F1537), matching the predicate's materials. The system supports single or multiple level fixations with straight and pre-lordosed rod configurations and variable-length cross connectors.

Static compression bending and torsion testing, dynamic compression bending, axial grip testing, and torsional grip testing were performed according to ASTM F1717 and ASTM F1798 on worst-case constructs.

The Tiger 2 System is substantially equivalent to predicate K222614 because it possesses identical technological characteristics in basic design (rod-based fixation with polyaxial screws), materials (titanium and cobalt chrome alloys), and intended clinical use. Mechanical performance testing demonstrated equivalency to the predicate device, confirming that the device maintains the same safety and functional standards despite being a new product offering from the manufacturer.