Plano, TX, July 14, 2026 –(PR.com)– Eminent Spine, a leader in advanced 3D implant technology, releases the early clinical and implant results of the world’s first FDA 510(k) approved 3D printed titanium pedicle screw.
The proprietary 3D printed pedicle screw, designed and manufactured by Eminent Spine received FDA 501(k) clearance on April 28, 2025. The new novel 3D titanium printing cutting edge technology surpassed the FDA biomechanical testing critria. A slow scientific clinical rollout was done intentionally to ensure patient safety. A logical, methodical clinical study was performed to ensure any unforeseen clinical patient or hardware issues or complications, due to the unique implant features. There were none.
A multi-center spine study group consisting of OrthoSpine and Neurosurgeons performed the study. This study examined 33 patients from July 2025 to present.
Diagnosis included loose pedicle screws, pseudoarthrosis, cervical-thoracic kyphosis, thoraco-lumbar kyphosis, post-laminectomy syndrome, degenerative disc disease, spondyolithesis and stenosis.
Risk factors, included were osteoporosis(8), loose pedicle screws(10), previous spinal fusions(20), TLK(8), diabetes(8), smoker(6), obesity(17). 2933 patients had previous spinal surgery.
252 3D titanium pedicle screws were implanted, and 154 were cannulated and 98 were non-cannulated. Screw diameters ranged from 6.0 to 7.5mm. Twelve side rod-rod connectors, 6 cross connectors, 76 5.5mm rods, and 264 set screw caps were utilized.
3 patients had dual rods, 3 patients underwent unilateral fixation, and no patient had pelvic fixation.
Levels performed were L5/S1(3), L4/S1(12), L3/S1(11), L2/S1(4), L1/S1(1), T10/S1(1), C2-T2-T8 extension(1).
Patients had AP & Lateral x-rays taken at follow up.
There were no screw fractures, no screw cut out, no screw back out, no loose screw, no “halo” effect, no set screw popped off, no set screw stripped, no rod fracture, no implant revision and no infections.
Discussion.
1. This clinical based study clearly validated the safety and clinical value of the Eminent Spine’s proprietary patented 3D titanium pedicle screw system. It is clearly an excellent choice for high risk patients, and revisions. Years of biomechanicial testing and over 75 million cycles of testing, along now with the clinical data, has marked the start of the next generation implant. The new “Future of Fusion” has been defined.
2. There were no hardware failures and no implant revisions. “As we move fast in a cost conscious era, it is important to identify implants that are effective and minimize complications, especially in regard to revision surgery.” – Steve Courtney, MD, President of Eminent Spine. If an implant can avoid the 20-60% loose pedicle screw rate leading to revision surgery, the cost saving to Hospital systems is paramount.
3. Surgeon tactical feedback while inserting the 3D titanium pedicle screw was nothing less than powerful and extraordinary. As the screw advances into the bone, the shaft of the screw is harvesting the bone inside the shaft of the screw, henceforth, the entire shaft is a fusion device. It does not push bone away, it forces bone into the internal matrix shaft for immediate fixation, and that is the best opportunity to minimize micro-motion leading to loose screws, leading to the dreaded “halo” effect.
4. The most used implant in spinal surgery is the Pedicle screw. The industry has made hundreds of implant, cages, expandable cages, different footprints, gimicks of implants that are not biomechanically sound, odd material, etc., but the most important feature is the screw shaft bone interface. The immediate fixation to the shaft and internal matrix of the screw to the bone is the most important starting point of the fusion process. The novel 3D lattice on the surface of the threads provide a massive surface area for enhanced fixation and fusion.
5. Eminent Spine’s proprietary patented 3D pedicle screw technology clearly stands alone, in the advancement of spinal technology and clinical results compared to “regular” pedicle screws. A “regular” pedicle screw is now of historical value in the new era of Spinal technology. The “Future of Fusion” is here and Eminent Spine has it. That has been proven.
Contact
Eminent Spine
Stephen Courtney
972-499-3593
www.eminentspine.com