Curiteva announces FDA 510(k) clearance for Inspire 3D porous PEEK HAFUSE cervical interbody system


Curiteva has received the 510(k) clearance from the US Food and Drug Administration (FDA) for its 3D printed PEEK implant, the Inspire porous PEEK cervical interbody system with HAFUSE technology.

The Inspire platform is manufactured with a proprietary, patented Fused Filament Fabrication 3D printer designed, programmed, and built by Curiteva.

This groundbreaking additive process produces a fully interconnected and integrated porous structure traversing the entire implant to promote osseointegration, improve radiographic assessment, and deliver superior biomechanics, say Curiteva.

The first-to-market combination of the HAFUSE 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.

Eric Linder, Curiteva’s chief technology officer, said: “The distinctive Inspire implant technology enabled by our innovative 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.”

Curiteva’s vice president of emerging technology, Todd Reith, added: “Our capability to integrate unique design elements utilising additive PEEK as an alternative to titanium to optimise beneficial material properties such as radiographic assessment and biomechanical load-sharing represents a significant leap forward in the design and development of medical devices.”

The company is currently planning a commercial launch in key academic centres across the United States.

“Curiteva is pioneering 3D printing of porous PEEK implants with a bioactive surface to revolutionise 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 commercialisation and scale to meet market demand inside our 35,000 square foot production facility in Huntsville,” commented CEO Mike English.


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