Plano, Texas-based Eminent Spine has achieved a significant milestone with FDA 510(k) clearance for its revolutionary 3D Printed Titanium Pedicle Screw System as of April 28, 2025. This regulatory approval makes it the first and only FDA-cleared 3D printed pedicle screw system globally, positioning the company at the forefront of spinal implant innovation.
"This historic achievement represents a monumental leap forward in the biomechanical and histological science of pedicle screw technology," said Patrick McDonough, National Director of Sales at Eminent Spine. "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."
Technological Advancements in Spinal Fixation
The newly approved system incorporates several innovative design elements specifically engineered to enhance surgical precision and improve patient outcomes. The technology features Eminent Spine's proprietary patented pedicle screw technology with cannulated, fenestrated screws manufactured from 100% 3D printed titanium.
A key advancement is the novel 3D lattice structure on the surface of the threads, designed to enhance fixation within the vertebral body. The system also employs a cortical/cancellous hybrid thread pattern with a triple lead screw design, optimizing purchase in different bone densities.
Perhaps most notable is the self-harvesting cutting flute design that doesn't displace bone during insertion but instead harvests it into the internal matrix of the screw, potentially improving osseointegration and stability.
System Specifications and Compatibility
The 3D Printed Titanium Pedicle Screw System offers comprehensive sizing options to accommodate various patient anatomies and surgical requirements:
- Screw diameters: 6.0mm, 6.5mm, 7.0mm, 7.5mm, and 8.0mm
- Screw lengths: 40mm to 60mm
- Compatible with 5.5mm straight or contoured rods
- Includes polyaxial tulips, cross connectors, and a comprehensive universal instrumentation set
This versatility allows surgeons to tailor the system to specific patient needs while maintaining procedural efficiency.
Clinical Significance and Future Impact
Dr. Stephen Courtney, Founder and CEO of Eminent Spine, emphasized the broader implications of this regulatory milestone: "Our mission has always been to innovate with purpose, and this clearance validates years of research, development, and surgeon collaboration. This is more than just a technological achievement — it's a new era in spine surgery."
The FDA's 510(k) clearance represents a significant endorsement of the company's approach to innovation in spinal surgery. By leveraging advanced 3D printing technology, Eminent Spine aims to address longstanding challenges in spinal fixation procedures while potentially improving surgical outcomes.
Market Positioning and Availability
Founded with a vision to redefine spinal solutions, Eminent Spine specializes in developing high-performance, surgeon-driven spinal implants. The company maintains a focus on biomechanics, surgical efficiency, and patient recovery.
With this clearance, Eminent Spine strengthens its position in the competitive spinal implant market. The 3D Printed Titanium Pedicle Screw System is expected to be available to surgeons in the coming months, with the company offering demonstrations and training on the new technology.
Healthcare providers interested in learning more about the system can visit the company's website at www.eminentspine.com or contact company representatives directly for additional information.
