Annex® 2 Adjacent Level System

The Annex® 2 Adjacent Level System is a spinal fixation device consisting of non-sterile locking screws, adjacent level devices, and connectors that attach to existing pedicle screw systems to extend and stabilize the spine. It is indicated for use in skeletally mature patients undergoing fusion surgery to treat degenerative disc disease, spondylolisthesis, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion in the thoracic, lumbar, and sacral spine.

The Annex® 2 Adjacent Level System has technological characteristics equivalent to the predicate devices, including identical design and material composition. The implant components are manufactured from titanium (ASTM F67), titanium alloy (Ti-6Al-4V ELI per ASTM F136), and cobalt-chromium (CoCr per ASTM F1537). The system can link to 4.75 mm, 5.5 mm, and/or 6.0 mm diameter rods from CapSure®, Sniper®, or Salvo® spine systems.

Static axial compression bending, static torsion testing, and dynamic axial compression bending testing were performed per ASTM F1717.

The Annex® 2 Adjacent Level System is substantially equivalent to the predicate devices because it has the same intended use in thoracolumbosacral revision surgery to extend existing pedicle spinal fixation instrumentation constructs, identical technological characteristics including design and material composition, and equivalent performance data as demonstrated by non-clinical biomechanical testing. No new issues of safety and effectiveness are raised by this device.