Plano, TX, May 07, 2025 –(PR.com)– Eminent Spine, a leader in spinal implant innovation, proudly announces that its revolutionary 3D Printed Titanium Pedicle Screw System has received FDA 510(k) clearance as of April 28, 2025 — 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.” – Patrick McDonough, National Director of Sales
Innovative Design & Superior Engineering
The 3D Printed Titanium Pedicle Screw System was designed with both surgeon precision and patient outcomes in mind. 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.”
The FDA’s 510(k) clearance marks a significant endorsement of Eminent Spine’s commitment to pushing the boundaries of what’s possible in spinal surgery, while ensuring safety, reliability, and superior clinical outcomes.
About Eminent Spine
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 remains at the forefront of orthopedic innovation.
For more information about the 3D Printed Titanium Pedicle Screw System or to schedule a demonstration, please visit www.eminentspine.com.
Contact
Eminent Spine
Michael McDonough
314-365-2581
www.eminentspine.com
Leave a Reply