Huntsville, AL – Newswire.com – Curiteva, Inc., a leading privately held, technology-driven manufacturing company, announces the recent 510(k) clearance from the FDA for a nanotechnology designation for its Inspire 3D Printed Trabecular PEEK family of implants, featuring proprietary HAFUSE Surface Technology. This regulatory allowance highlights the implants’ advanced physical and functional attributes, and advanced hydrophilicity, further strengthening the claims for the Inspire Interbody Implants.

Eric Linder, Curiteva’s Co-Founder and Chief Technology Officer, highlighted the importance of this designation stating, “The FDA’s acknowledgment of our nanotechnology claim provides additional validation of our innovative design, confirming compliance with the agency’s guidelines for nanotechnology-based materials and reinforcing the Inspire technology as a pioneering solution within the medical implant sector.”

The implants’ nanoscale surface texture consists of a uniform nanocrystalline hydroxyapatite layer, measuring approximately 10-20 nm in thickness, with individual crystals averaging 91.5 nm in length and 10 nm in width. Combined with Inspires proprietary macrostructures – engineered to mimic the size, shape, and structure of natural bone – it creates a biologically compatible environment that promotes faster and stronger osseointegration. The HAFUSE Surface Technology transforms the implant surface from hydrophobic to hydrophilic, enhancing its interaction with biological tissues and improving clinical outcomes.

Curiteva’s Chief Scientific Officer, Erik Erbe, PhD, commented, “Nanoscale surface modification of our implant’s trabecular lattice represents a paradigm shift in the era of smart implants, altering both proscriptively and predictively their biologic response at the bone tissue interface. This allows a traditionally, non-regenerative (fibrous), hydrophobic material to be transformed into a regenerative, anti-inflammatory surface that promotes osseointegration – comparable to the best-in-class bone grafts available today.”

This nano designation represents a major achievement for Curiteva, validating its unwavering dedication to advancing spinal implant technology. By harnessing cutting-edge material science at the nanometer scale, the company continues to push the boundaries of medical device engineering, setting a new standard for innovation and excellence in the industry.