FDA Grants 'Nanotechnology Designation' to 3D-Printed PEEK-Based Implant

Curiteva's 3D-printed PEEK-based trabecular implant has received FDA 510(k) clearance, and the company refers to it as "nanotechnology-enabled." While the FDA has not established a uniform classification for medical devices incorporating nanotechnology, the agency can confirm that the device's nanoscale characteristics have been evaluated in accordance with relevant regulations.

Enhanced interaction between implant surfaces and biological tissues

The nanometer-scale surface texture of the Inspire interbody fusion device, composed of a uniform 10–20 nanometer thick layer of nanocrystalline hydroxyapatite, with individual crystals averaging 91.5 nanometers in length and 10 nanometers in width, combined with Inspire's proprietary macrostructure (which Curiteva states mimics the size, shape, and structure of natural bone), creates a biocompatible environment with its HAFuse surface technology that promotes faster and more robust bone integration. The Huntsville, Alabama-based company added that the HAFuse surface technology transforms the implant surface from hydrophobic to hydrophilic, enhancing its interaction with biological tissues and improving clinical outcomes.

“FDA recognition of our nanotechnology claims further validates our innovative design,” said Eric Linder, Curiteva co-founder and CTO. He added that the clearance confirms the “product adheres to the agency’s guidance principles for nano-based materials and reinforces Inspire technology’s position as a groundbreaking solution in the medical implant space.”

A Paradigm Shift in Smart Implants

Dr. Erik Erbe, Curiteva's Chief Scientific Officer, stated that the company's nanoscale surface modification of implant trabecular lattices marks a paradigm shift in the era of smart implants. He elaborated that by proactively and predictably altering the biological response at the bone-tissue interface, this technology "transforms traditionally non-regenerative (fibrous), hydrophobic materials into regenerative, anti-inflammatory surfaces that promote osseointegration comparable to the top bone graft materials currently on the market."

Curiteva, founded in 2017, is a privately held company focused on developing a proprietary portfolio of spinal implant products to accelerate healing and improve patient outcomes.