Eminent Backbone, a spinal implant innovator, has acquired FDA 510(ok) clearance for its 3D Printed Titanium Pedicle Screw System – making it the primary and solely FDA 510(ok)-cleared 3D printed pedicle screw system on this planet.
“This historic achievement represents a monumental leap ahead within the biomechanical and histological science of pedicle screw know-how. With this clearance, Eminent Backbone units a brand new world normal in spinal fixation and fusion options, mixing cutting-edge 3D printing with superior spinal biomechanics,” stated Patrick McDonough, Nationwide Director of Gross sales at Eminent Backbone.
The 3D Printed Titanium Pedicle Screw System was designed with each surgeon precision and affected person outcomes in thoughts. Key options embody proprietary patented pedicle screw know-how; cannulated, fenestrated screws made out of 100% 3D printed titanium; a novel 3D lattice on floor of the threads for enhanced fixation; a cortical/cancellous hybrid thread sample and triple lead screw; and self harvesting reducing flutes that doesn’t displace bone, and harvests the bone into the interior matrix of the screw.
Screw sizes out there in 6.0mm, 6.5mm, 7.0mm, 7.5mm, and eight.0mm diameters, with lengths from 40mm to 60mm, and are suitable with 5.5mm straight or contoured rods, polyaxial tulips, cross connectors, and a complete common instrumentation set.
“Our mission has all the time been to innovate with objective, and this clearance validates years of analysis, improvement, and surgeon collaboration,” stated Dr. Stephen Courtney, Founder and CEO of Eminent Backbone. “That is greater than only a technological achievement – it’s a brand new period in backbone surgical procedure.”
