Sovereign Posterior Cervical System

The Sovereign Posterior Cervical System is an implant device for posterior stabilization of the cervical and upper thoracic spine. It includes polyaxial screws, blocker screws, rods, crosslinks, lateral connectors, and rod-to-rod connectors made from titanium alloy or cobalt chrome. The system is used to immobilize and stabilize spinal segments as an adjunct to fusion for conditions including traumatic fractures, degenerative disease, tumors, and failed previous fusions.

The device uses polyaxial screws in standard and reduction tulips, straight/pre-bent/transition rods in 3.5mm and 4.0mm diameters, and various connectors and crosslinks. All components are manufactured from titanium alloy (Ti-6Al-4V ELI per ASTM F136) or cobalt chrome (Co-Cr28-Mo6 per ASTM F1537). The system's design, surgical approach, materials, size range, and operating principles are similar to predicate devices, with no differences that raise safety or effectiveness questions.

ASTM F1717 static compression bending, ASTM F1798 static axial gripping capacity and static torsional gripping capacity.

The Sovereign system has identical or similar indications for use as the predicate devices (Centurion POCT, Z-LINKPC, Synapse OCT, and VERTICALE systems). Mechanical testing using ASTM standards demonstrated the worst-case constructs were substantially equivalent to legally marketed predicate devices. The technological characteristics, materials, design, and principles of operation are substantially equivalent, with any differences not raising different questions of safety or effectiveness.