Eminent Spine’s 3D Printed SI Screw System Gains FDA Approval
Eminent Spine has received FDA 510(k) clearance for its additively manufactured and machined titanium SI Screw System. This system will be presented at the State of Spine Surgery Think Tank in Cabo, Mexico (June 20-22, 2024), and the ASPN Annual Conference in Miami, Florida (July 11-14, 2024).
The SI Screw System includes multiple sizes and configurations tailored to individual patient anatomy. It features a tapered nose for easy insertion and a sharp tip for effective bone penetration. Screw lengths range from 20 to 90 mm with diameters of 8.5 mm, 10 mm, 11.5 mm, and 13.0 mm. Options include head and headless screws, fenestrated designs, and self-harvesting threads, offering surgeons flexibility based on the specific surgical requirements.
The system is approved for lateral, superior lateral, and S2-AI approaches, enhancing its versatility for various surgical applications. By addressing different anatomical needs and surgical techniques, the system aims to improve patient outcomes and reduce surgical complications.
Eminent Spine’s new SI Screw System provides a comprehensive solution for sacroiliac joint fusion procedures, leveraging the advantages of 3D printing technology to deliver precision and customization. The combination of additively manufactured components and traditional machining ensures both high quality and tailored fit for patients, marking a significant development in spinal surgery.
