Curiteva receives FDA 510(k) clearance of 3D-printed, porous cervical interbody implant

Fact checked byGina Brockenbrough, MA

Curiteva Inc. has announced FDA 510(k) clearance for its Inspire porous polyetheretherketone cervical interbody system with Hafuse technology, according to a company press release.

The Inspire implant, designed with 3D printing, utilizes a porous structure to promote osseointegration, improve visualization on radiographs and closely match the native biomechanics, according to the release.

Spine doctor — Curiteva received FDA 510(k) clearance for its Inspire porous polyetheretherketone cervical interbody system with Hafuse technology. *Image: Adobe Stock*

“Curiteva is pioneering 3D printing of porous [polyetheretherketone] implants with a bioactive surface to revolutionize how engineered structures and implant biomaterials enhance healing and improve patient outcomes,” Mike English, CEO of Curiteva, said in the release. “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, [Alabama],” he added.

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Curiteva receives FDA 510(k) clearance of 3D-printed, porous cervical interbody implant

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