Eminent Spine Gains 510(k) for 3D-Printed Titanium Pedicle Screw

Eminent Spine received FDA 510(k) clearance to market its 3D-Printed Titanium Pedicle Screw System, making it the first and only FDA-cleared 3D-printed pedicle screw system in the world.

Key features include:

• Eminent Spine’s proprietary patented pedicle screw technology
• Cannulated, fenestrated screws made from 100% 3D printed titanium
• Novel 3D Lattice on surface of the threads for enhanced fixation
• Cortical/cancellous hybrid thread pattern and triple lead screw
• Self harvesting cutting flutes that does not displace bone, it harvests the bone into the internal matrix of the screw
• Screw sizes available in 6.0mm, 6.5mm, 7.0mm, 7.5mm and 8.0mm diameters, with lengths from 40mm to 60mm
• Compatibility with 5.5mm straight or contoured rods, polyaxial tulips, cross connectors and a comprehensive universal instrumentation set

“Our mission has always been to innovate with purpose, and this clearance validates years of research, development, and surgeon collaboration,” said Dr. Stephen Courtney, Founder & CEO of Eminent Spine. “This is more than just a technological achievement — it’s a new era in spine surgery.”

Source: Eminent Spine

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