Eminent Spine achieves FDA 510(k) clearance
The 3D Printed Titanium Pedicle Screw System is the first to receive such clearance
Eminent Spine, a spinal implant innovator, has received FDA 510(k) clearance for its 3D Printed Titanium Pedicle Screw System – making it the first and only FDA 510(k)-cleared 3D printed pedicle screw system in the world.
“This historic achievement represents a monumental leap forward in the biomechanical and histological science of pedicle screw technology. With this clearance, Eminent Spine sets a new global standard in spinal fixation and fusion solutions, blending cutting-edge 3D printing with advanced spinal biomechanics,” said Patrick McDonough, National Director of Sales at Eminent Spine.
The 3D Printed Titanium Pedicle Screw System was designed with both surgeon precision and patient outcomes in mind. Key features include proprietary patented pedicle screw technology; cannulated, fenestrated screws made from 100% 3D printed titanium; a novel 3D lattice on surface of the threads for enhanced fixation; a cortical/cancellous hybrid thread pattern and triple lead screw; and self harvesting cutting flutes that does not displace bone, and 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, and are compatible 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 and CEO of Eminent Spine. “This is more than just a technological achievement – it’s a new era in spine surgery.”
