The US medical technology company Eminent Spine has received 510(k) clearance from the US Food and Drug Administration (FDA) for a fully 3D-printed titanium pedicle screw system. This makes the system the first of its kind to receive such regulatory clearance in spinal implant technology in the US. The approval is for clinical use in spinal stabilization and fusion.
The newly developed screw system combines a fully additive manufactured design with biomechanical properties specifically developed for spinal surgery. The screws consist of a porous titanium structure designed to promote improved osseointegrative connection. According to the manufacturer, a special microstructure on the thread flanks – a so-called 3D lattice surface – is intended to increase primary stability and at the same time enable controlled bone interaction. In addition, the system has self-tapping flanks that do not displace bone material, but instead embed it in the internal structure of the screw.
“This historic achievement represents a monumental leap forward in the biomechanical and histological science of pedicle screw technology. With this clearance, Eminent Spine sets a new global standard in spinal fixation and fusion solutions, blending cutting-edge 3D printing with advanced spinal biomechanics”, said Patrick McDonough, National Director of Sales.
The system includes various screw sizes with diameters between 6.0 mm and 8.0 mm and is compatible with standardized instrument sets. It can be combined with 5.5 mm rods and polyaxial fasteners.
“Our mission has always been to innovate with purpose, and this clearance validates years of research, development, and surgeon collaboration,” said Dr. Stephen Courtney, Founder & CEO of Eminent Spine. “This is more than just a technological achievement — it’s a new era in spine surgery.”
FDA approval is a significant regulatory step and confirms that the safety and performance requirements for use in a clinical environment have been met. For additive manufacturing in medical technology, this case underlines the increasing relevance of patient-specific adaptability, functional integration and complex geometries, which can only be realized to a limited extent with conventional manufacturing processes.
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