HUNTSVILLE – Curiteva has received FDA approval to launch its Inspire Porous PEEK HAFUSE Cervical Interbody System.
The Huntsville-based technology and manufacturing company received FDA clearance in February and initiated its alpha release in April. It is now scaled for full commercial launch.
Curiteva pioneered the world’s first 3D printed, fully interconnected porous PEEK interbody. The system helps create a classification of interbody fusion devices with optimal characteristics for bone healing.
“We are very pleased with the positive surgeon feedback we received during our limited release in April,” said Curiteva Executive Vice President Mark Mohlman. “Now with full commercialization, the team is excited to see continued adoption of our novel 3D printed porous PEEK implant with HAFUSE Technology.
“This launch is just the beginning as we continue to develop our additional lumbar portfolio scheduled for launch in 2024.”
The Inspire platform is manufactured with a proprietary, patented Fused Filament Fabrication 3D printer designed, programmed, and built by Curiteva.
The additive process produces a connected and integrated porous structure traversing the implant to promote osseointegration, improve radiographic assessment, and deliver superior biomechanics.
The product creates a hydrophilic, bioactive environment for cell attachment, proliferation, and healing in pre-clinical animal and in vitro studies.
“I am proud of the entire Curiteva team for another milestone achievement, and I am grateful to our surgeons and distributors for their patience and support,” said Curiteva CEO Mike English.
The Inspire technology will be featured at the North American Spine Society meeting this year.
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