HUNTSVILLE, AL / ACCESS Newswire / June 24, 2025 / Curiteva is proud to announce FDA 510(k) clearance for the Inspire Trabecular PEEK Standalone ALIF system, the first-ever 3D printed PEEK standalone implant. This is the company's latest FDA cleared 3D Printed PEEK implant with HAFUSE technology. This milestone represents a significant leap forward in advanced medical solutions and further solidifies Curiteva's position as a leader in healthcare innovation.
"This FDA 510(k) clearance reinforces Curiteva's dedication to advancing implant innovation through our proprietary 3D-printed Inspire® Trabecular PEEK technology," said Eric Linder, Founder and Chief Technology Officer at Curiteva. "We remain focused on executing our vision of pioneering industry-first implants that feature fully integrated porosity, exceptional radiographic visibility, and optimal biomechanical properties engineered to promote osseointegration across the entire construct."
The rapid achievement of this 510(k) clearance was driven by Curiteva's proprietary Master File for Inspire technology, a distinctive asset that significantly streamlined the regulatory process and validated the cutting-edge nature of the system. Building on the previous success of the Inspire Lumbar Interbody clearance, this landmark approval reinforces Curiteva's proven ability to deliver world-class medical advancements at an accelerated pace.
Dr. Stephen Tolhurst from Texas Back Institute noted, "I've been using the Inspire with HAFUSE technology for over two years. The results I am seeing and the timeframe in which they are achieved is striking. The implant design and cage technology are truly unique and allow for visual confirmation of bone growth both on and through the implant. I'm excited to bring the newly cleared Inspire Trabecular PEEK Standalone ALIF System into my practice and look forward to the positive impact it will have on patient outcomes."
"This milestone is not only a reflection of our team's extraordinary capabilities but also a promising leap forward for surgeons and their patients," stated Curiteva's Founder, Chad Falciani. "It represents years of research, collaboration, and ambition realized in a tangible solution that will redefine spinal care."
The Inspire Technology will be featured at the State of Spine Surgery Think Tank in San Jose del Cabo, Mexico this week.
About Curiteva:
Curiteva is a privately held technology and manufacturing company based in Huntsville, AL. Our business is founded on a commitment to building world-class manufacturing, accelerating research and development, maintaining lean operational discipline, and delivering novel technology to meet the evolving needs of our customers and the patients they serve. Curiteva is pioneering 3D printing of Trabecular PEEK implants with a proprietary HAFUSE sub-micron surface designed to revolutionize how engineered structures and implant biomaterials promote osseointegration, accelerate healing, and improve patient outcomes. For more information, please visit www.curiteva.com
Contact Information
Kristen Kyzer
Director of Business Development
kkyzer@curiteva.com
256.213.1057
SOURCE: Curiteva
View the original press release on ACCESS Newswire:
https://www.accessnewswire.com/newsroom/en/healthcare-and-pharmaceutical/curitevar-secures-fda-510k-clearance-for-inspirer-trabecular-peek-sta-1042325
