Curiteva Gains 510(k) for Inspire Lumbar Interbody Implant

Curiteva gained FDA 510(k) clearance to market the Inspire 3D Printed Trabecular PEEK Lumbar Interbody Fusion System for use in anterior, transforaminal, posterior and lateral lumbar interbody fusion.

This marks the company’s second FDA-cleared 3D-printed PEEK implant with HAFUSE, following the clearance of the Inspire Trabecular PEEK Cervical Interbody Fusion System in 2023. The Inspire Cervical implant represented the industry’s first 3D printed PEEK device to receive regulatory clearance with over 1,000 successful implantations in more than 500 patients since the April 2023 launch. The company plans a commercial introduction of Inspire for TLIF and PLIF procedures in 2Q24.

The Inspire platform is manufactured with a proprietary, patented Fused Filament Fabrication 3D printer designed, programmed and built by Curiteva. This additive process produces a fully interconnected and integrated trabecular PEEK lattice structure traversing the entire implant to promote osseointegration, improve radiographic assessment and deliver superior biomechanics. The combination of the HAFUSE nanotechnology surface treatment and trabecular PEEK structure creates a hydrophilic, bioactive environment for cell attachment, proliferation and healing in preclinical animal and in vitro studies.

Source: Curiteva