Virage® OCT Spinal Fixation System

The Virage® OCT Spinal Fixation System is a posterior cervical fixation system that provides immobilization and stabilization of the occipital-cervical-thoracic spine (occiput to T3) as an adjunct to fusion. It is intended for treatment of traumatic fractures, dislocations, degenerative disease, tumors, and failed previous fusions of the cervical spine. The system can be connected to the Vital Spinal Fixation System for extended fixation to lower thoracic and lumbar levels.

The Virage® OCT System maintains the same materials (medical grade titanium alloy and cobalt chromium alloy), design, manufacturing methods, and operational principles as the predicate Virage® System (K153631). The submission adds new rod-to-rod connectors and MRI conditional labeling based on ASTM testing. Various minor changes previously cleared via Letters-to-File are also included.

ASTM F2052 (magnetically induced displacement force), ASTM F2182 (radio frequency induced heating), ASTM F2213 (magnetically induced torque), ASTM F2119 (MR image artifacts), ASTM F1717 (spinal implant constructs in vertebrectomy mode), and ASTM F1798 (static and fatigue properties of interconnection mechanisms).

The subject device uses identical materials and manufacturing processes as the predicate, maintains the same intended use and indications for use, and performs the same function with equivalent technological characteristics. The new connectors underwent mechanical testing demonstrating acceptable performance, and MRI compatibility testing confirmed safe operation in MR environments. Since the fundamental design, materials, and performance are substantially equivalent to the cleared predicate, the device requires no new premarket approval.