FDA Grants 510(k) Clearance to SpineCraft’s ANTERIS Thoracolumbar Plate System

SpineCraft has earned U.S. Food and Drug Administration 510(k) clearance for the ANTERIS Thoracolumbar Plate System, an anterior fixation solution that provides supplemental stabilization for anterior lumbar interbody fusion procedures.

The ANTERIS plate system is used with anterior lumbar interbody fusion devices and is designed to pair seamlessly with SpineCraft’s ORIO ALIF cage portfolio—available in three distinct material options: PEEK OPTIMA (ORIO ALIF), titanium alloy Ti6Al4V ELI (ORIO-Ti ALIF), and additively manufactured porous Ti6Al4V ELI (ORIO-3D ALIF). The ANTERIS plate system is engineered to support the development of a solid spinal fusion construct while helping with faster mobilization and post-surgical recovery.

Designed with a low-profile and pre-contoured lumbar and sacral plate geometry, ANTERIS is built to accommodate a wide range of patient anatomies and vertebral body variations without intraoperative bending. Available in standard and large configurations, the system meets various clinical needs and provides a complete sizing range to support optimal implant fit in challenging anterior lumbar applications while streamlining overall implant placement. Additionally, ANTERIS screw sizes are compatible with the ORIO-3D ALIF Stand-alone cage, simplifying inventory management.

The ANTERIS plate system incorporates an integrated locking mechanism to maintain screw engagement and construct integrity after implantation. The system is supported by streamlined instrumentation designed to simplify intraoperative workflow.

The ANTERIS plate system further expands the company’s portfolio of spinal implant technologies focused on procedural efficiency and anatomical compatibility in anterior lumbar fusion procedures.

SpineCraft develops, manufactures, and markets outcome-driven spine surgery systems that provide comprehensive spine care for patients with spine deformities, complex spine problems, degenerative spine conditions and spine trauma. The company is headquartered in Westmont, Ill., with distribution channels in the United States, Europe, the Middle East and Asia-Pacific.