Eminent Spine 3D Titanium Pedicle Screw System

The Eminent Spine 3D Titanium Pedicle Screw System is a spinal fixation device consisting of titanium rods, polyaxial screws, set caps, and cross connectors. It is designed to provide immobilization and stabilization of the thoracic, lumbar, and sacral spine as an adjunct to fusion surgery in skeletally mature patients with conditions such as severe spondylolisthesis, degenerative disc disease, fracture, spinal stenosis, scoliosis, and spinal tumors.

The system features 5.5mm diameter rods (straight or pre-contoured with 154mm radius of curvature), cannulated polyaxial screws in diameters from 6.0mm to 8.0mm, and adjustable cross connectors in three length ranges. All components are manufactured from Ti6Al4V ELI titanium alloy per ASTM F3001 (screws) and ASTM F136 (tulip, set cap, rod, and cross link systems). The device is sold non-sterile and relies on mechanical fixation via set caps and lock screws.

ASTM F1717 (static torsion, static and dynamic compression bending); ASTM F543 (torsional strength, driving torque, and axial pullout); ASTM F2193 (static cantilever bending and dynamic cantilever bending).

The device is substantially equivalent because its technological design features—including intended use, indications, design, function, and material composition—are equivalent to the predicate devices (Diamondback Spinal System, Synergy CLS, Moss Miami System, and CD Horizon). Mechanical testing using standard ASTM methods demonstrates performance comparable to these predicates, supporting functional and safety equivalence for posterior pedicle fixation in the indicated patient populations.