An early multicenter study evaluated Eminent Spine’s FDA 510(k)-cleared 3D-printed titanium pedicle screw in 33 patients undergoing spinal procedures.
The study included patients treated from July 2025 to the present for conditions including loose pedicle screws, pseudoarthrosis, cervical-thoracic kyphosis, thoraco-lumbar kyphosis, post-laminectomy syndrome, degenerative disc disease, spondylolisthesis and stenosis. Surgeons implanted 252 3D-printed titanium pedicle screws, including 154 cannulated and 98 non-cannulated devices, according to a July 14 news release.
Investigators reported no screw fractures, screw cutout, screw backout, loose screws, rod fractures, implant revisions, infections or other hardware-related complications during follow-up. Patients underwent anteroposterior and lateral X-rays after surgery.
The proprietary pedicle screw received FDA 510(k) clearance April 28, 2025. The company said the findings support further evaluation of the device in patients undergoing spinal fusion procedures.
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