Eminent Spine has won U.S. Food and Drug Administration (FDA) 510(k) clearance for its 3D printed Titanium Pedicle Screw System, believed to be the only product of its kind 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,” Eminent Spine National Sales Director Patrick McDonough said.

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 3D printed titanium
• Novel 3D lattice on the thread surface for enhanced fixation
• Cortical/cancellous hybrid thread pattern and triple lead screw
• Self harvesting cutting flutes that do not displace bone, but rather harvest bone into the screw’s internal matrix
• Screw sizes available in 6mm, 6.5mm, 7mm, 7.5mm, and 8mm 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,” Eminent Spine Founder/CEO Dr. Stephen Courtney stated. “This is more than just a technological achievement, it’s a new era in spine surgery.”

Founded with a vision to redefine spinal solutions, Eminent Spine specializes in developing high-performance, surgeon-driven spinal implants. With a focus on biomechanics, surgical efficiency, and patient recovery, Eminent Spine strives to stay at the forefront of orthopedic innovation.