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510(k) clearance·Press Release

SpineCraft Announces U.S. FDA 510(k) Clearance of ANTERIS Thoracolumbar Plate System

Monday, May 18, 2026
SpineCraft Announces U.S. FDA 510(k) Clearance of ANTERIS Thoracolumbar Plate System

Westmont, Illinois, May 18, 2026, / OrthoSpineNews / – SpineCraft, a U.S.-based spine surgery systems developer and manufacturer, announces U.S. FDA 510(k) clearance of the ANTERIS Thoracolumbar Plate System, a comprehensive anterior fixation solution designed to provide supplemental stabilization for anterior lumbar interbody fusion procedures.





The ANTERIS plate system is intended for use with anterior lumbar interbody fusion devices and is designed to pair seamlessly with the entire 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 faster mobilization and recovery following surgery.





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 the need for intraoperative bending. Available in both standard and large configurations, the system meets different clinical needs and provides a complete sizing range intended 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, helping to simplify inventory management.





The ANTERIS plate system incorporates an integrated locking mechanism intended 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 SpineCraft’s portfolio of spinal implant technologies focused on procedural efficiency and anatomical compatibility in anterior lumbar fusion procedures.





About SpineCraft





SpineCraft is an innovative medical device company focused on developing, manufacturing and marketing a complete portfolio of outcome-driven spine surgery systems that provide comprehensive spine care for patients with spine deformities, complex spine problems, degenerative spine conditions and spine trauma. For more information, please visit  http://www.spinecraft.com

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