FDA clearance of 3D-printed titanium pedicle screw system from Eminent Spine introduces new standard for spinal fixation.
Spine Surgery Changes the Script with New 3D-Printed Titanium Pedicle Screw System to be Cleared by the FDA
The FDA has granted clearance for the 3D-Printed Titanium Pedicle Screw System from Eminent Spine with 510(k) approval and has also stated that the system is the first and only 510(k)-cleared 3D-printed pedicle screw system currently for sale in the United States. Today’s announcement is stepping down from such a breakthrough in spine surgery using both 3DP and bio-mechanic wizardry.
The system was created by Eminent Spine, a spinal implant technology leader, to help improve surgical accuracy and patient results. The screws are designed with a patented configurative 3D lattice surface for enhanced fixation, a hybrid thread form and self-harvesting cutting flutes that add value in a number of ways including bone preservation. The system features a straight or pre-curved rod in diameters from 6.0mm to 8.0mm and lengths up to 60mm and is compatible with standard spinal instrumentation.
“This is a major advance in spinal fusion technology,” added Patrick McDonough, National Director of Sales for Eminent Spine. “Our system establishes a new worldwide standard of care, combining advanced engineering with Made-in-Germany clinical excellence.”
Dr. Stephen Courtney, Founder & CEO of Eminent Spine, emphasized the years of research and collaboration behind the breakthrough. “This clearance isn’t just about innovation it’s about transforming patient care and surgical outcomes,” he said.
FDA clearance reinforces the safety and efficacy of the system, clearing the path for more widespread implementation in spine surgery. And with a design and materials edge, the future for patients is promising: the 3D-printed titanium system will help reduce operative time, increase fusion rates and improve long′term outcomes.
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Eminent Spine remains at the forefront of orthopedic innovation through a dedication to our surgeon driven solutions and biomechanical superiority. This breakthrough demonstrates the company’s leadership in medical technology and welcomes the new age of spine surgery.
