FDA Clears Curiteva’s Inspire 3D Porous PEEK Cervical Interbody System

Curiteva has received U.S. Food and Drug Administration 510(k) clearance for the first 3D-printed PEEK implant, the Inspire Porous PEEK Cervical Interbody System with HA^FUSE technology.

The Inspire platform is manufactured with a proprietary, patented Fused Filament Fabrication 3D printer that was designed, programmed, and built by Curiteva. This additive process produces a fully interconnected and integrated porous structure traversing the entire implant to promote osseointegration, improve radiographic assessment, and deliver superior biomechanics. The first-to-market combination of the HA^FUSE nanotechnology surface treatment and novel porous PEEK structure creates a hydrophilic, bioactive environment for cell attachment, proliferation, and healing in pre-clinical animal and in-vitro studies.
 
“The distinctive Inspire implant technology enabled by our 3D printing process incorporates an engineered lattice structure with fully interconnected porosity exhibiting superior mechanical strength and achieving a modulus of elasticity closely matching human cancellous bone,” Co-Founder/Chief Technology Officer Eric Linder said.

“Our capability to integrate unique design elements utilizing additive PEEK as an alternative to titanium to optimize beneficial material properties such as radiographic assessment and biomechanical load-sharing represents a significant leap forward in the design and development of medical devices,” inventor and Vice President of Emerging Technology Todd Reith added.
 
The company plans a commercial launch in key U.S. academic centers. “Curiteva is pioneering 3D printing of porous PEEK implants with a bioactive surface to revolutionize how engineered structures and implant biomaterials enhance healing and improve patient outcomes. We are uniquely positioned to control the product development process of traditional implants and 3D printed devices from inception to commercialization and scale to meet market demand inside our 35,000-square-foot production facility in Huntsville,” CEO Mike English stated.
 
Huntsville, Ala.-based Curiteva is a privately held technology and manufacturing company developing solutions for spine surgery by partnering with providers and suppliers to deliver implant systems to market.