Eminent Backbone, a spinal implant innovator, has obtained FDA 510(okay) clearance for its 3D Printed Titanium Pedicle Screw System – making it the primary and solely FDA 510(okay)-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 expertise. With this clearance, Eminent Backbone units a brand new international customary 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 embrace proprietary patented pedicle screw expertise; cannulated, fenestrated screws created from 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 chopping 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 appropriate with 5.5mm straight or contoured rods, polyaxial tulips, cross connectors, and a complete common instrumentation set.
“Our mission has at all times been to innovate with function, 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.”