ANTERIS Thoracolumbar Plate System

The ANTERIS Thoracolumbar Plate System is an anterior spinal fixation device made of titanium alloy (Ti-6Al-4V ELI) designed to provide temporary stabilization of the thoracic, lumbar, and sacral spine (T1-S1) in skeletally mature patients. It is indicated for treating various acute and chronic spinal instabilities including trauma, degenerative disc disease, spondylolisthesis, deformities, and spinal stenosis via lateral, anterolateral, or anterior surgical approaches depending on the spinal region being treated.

The device features pre-contoured titanium alloy plates with a central vertical slot to facilitate visualization and graft placement, offered in standard and large versions. It includes anti-backout caps to prevent screw back-out. The plates and bone screws are manufactured from titanium alloy (Ti-6Al-4V ELI) per ASTM F136, matching the composition and design features of the predicate devices.

ASTM F1717-18 was used for mechanical testing, including static compression bending, dynamic compression bending, and static torsion tests. The device is also subject to Quality Management System Regulation (QMSR) requirements including ISO 13485 clauses for design controls, nonconforming product, and corrective/preventative action.

Substantial equivalence is established through identical intended use, material composition (titanium alloy Ti-6Al-4V ELI), similar technological characteristics including design and anti-backout features, and comparable range of sizes to predicate devices Raven Anterior Lumbar Plate and Presidio Anterior Lumbar Plate System. Non-clinical performance testing demonstrates equivalent strength and performance to legally marketed predicate devices.