Technology company Curiveta has been granted an FDA 510(k) clearance for the Inspire 3D Printed Trabecular PEEK Lumbar Interbody Fusion System – which can be used in anterior, transforaminal, posterior, and lateral lumbar interbody fusion procedures.
As a reminder, the company received last year its first FDA clearance for its 3D printed PEEK implant.
The Inspire platform is manufactured with a proprietary, patented Fused Filament Fabrication 3D printer designed, programmed, and built by Curiteva. Founder and Chairman, Chad Falciani emphasized, “In addition to our proprietary printing operation, we have assembled an FDA Master File and implemented rigorous quality and process controls which demonstrates the process performance is extremely capable.”
This Additive Manufacturing 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 first-to-market combination of the HAFUSE nanotechnology surface treatment and novel trabecular PEEK structure creates a hydrophilic, bioactive environment for cell attachment, proliferation, and healing in pre-clinical animal and in vitro studies.
“Advancements in PEEK over the last decade were cost-prohibitive and operationally challenging to scale. Our experience and commitment to lean operational efficiency allowed us to accelerate our proprietary print operation resulting in over 7,000 implants now commercially available in inventory,” added Falciani.
“Reported patient outcomes for Inspire cervical in the first 9 months reinforce our pre-clinical observations and we plan to publish those results later this year. Our work continues in earnest to develop additional spine portfolio products leveraging this proprietary technology. We are thankful for our partners at MCRA, Empirical, Promimic, and Evonik for their extraordinary support on this regulatory path we are forging to advance additive PEEK manufacturing to improve patient healing and outcomes in the spine and MSK space,” commented CEO Mike English.
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