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Curiteva announces FDA 510(k) clearance for PEEK cervical interbody system

Source:        DateTime:2023.03.20        Hits:

Alabama-based technology company Curiteva has announced a FDA 510(k) cleared 3D printed PEEK implant, the Inspire Porous PEEK Cervical Interbody System with HAFUSE technology.

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

The process produces a fully interconnected and integrated porous structure traversing the implant to promote osseointegration, improve radiographic assessment, and deliver superior biomechanics according to the company.

Curiteva says the first-to-market combination of the HAFUSE nanotechnology surface treatment and novel porous PEEK structure creates a hydrophyllic, bioactive environment for cell attachment, proliferation, and healing in preclinical animal and in vitro studies.

“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,” said Curiteva Chief Technology Officer Eric Linder.

Curiteva 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 plans a commercial launch for the product in key academic centres across the United States. According to the company’s press release, it aims to ‘revolutionise’ how engineered structures and implant biomaterials enhance healing and improve patient outcomes. 

Mike English, CEO of Curiteva, said: “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.”