FDA Grants Nanotechnology Designation to Curiteva’s 3D-Printed PEEK Spinal Implants

Curiteva has received a nanotechnology designation from the U.S. Food and Drug Administration (FDA) for its Inspire 3D Printed Trabecular PEEK spinal implant system. The designation, granted through the FDA’s 510(k) pathway, recognizes the incorporation of nanoscale features in the implants’ design and surface characteristics.

At the core of this designation is Curiteva’s proprietary HAFUSE Surface Technology, which produces a nanocrystalline hydroxyapatite layer on the implant surface. According to the company, the coating measures approximately 10 to 20 nanometers in thickness, with individual crystals averaging 91.5 nanometers in length and 10 nanometers in width. These nanoscale features are integrated with a larger trabecular lattice structure that is designed to resemble cancellous bone.

Curiteva states that the nano-textured surface improves hydrophilicity and provides a more favorable environment for bone integration. The company also reports that applying nanoscale features to the implant’s porous PEEK lattice changes its interaction at the bone interface, citing a shift from a hydrophobic to a hydrophilic and bioactive surface.

“This designation confirms that the Inspire technology meets the FDA’s definition of nanotechnology,” said Eric Linder, co-founder and chief technology officer at Curiteva.

Erik Erbe, PhD, Curiteva’s chief scientific officer, noted that the nanoscale surface alters the biological response compared to traditional PEEK materials. He described the modified surface as having properties similar to those of established bone graft materials in terms of osseointegration.

The Inspire platform utilizes 3D-printed trabecular PEEK, a material manufactured through additive processes to create a porous structure intended to facilitate bone growth. The company has previously received FDA clearances for other devices within the Inspire product family that feature its surface modification technologies.

Curiteva is a privately held company based in Huntsville, Alabama, focused on developing spinal implant systems and manufacturing technologies for orthopedic applications.