Regulatory Clearance Granted for 3D-Printed Spinal Implants
Photo credit: Curiteva
Alabama-based technology company, Curiteva has received 510(k) clearance from the United States’ Food and Drugs Administration (FDA) for its unique 3D-printed implant, the Inspire Porous PEEK Cervical Interbody System with HAFUSE Technology.
The implant device, designed with 3D printing, utilises a strong yet elastic synthetic polymer known as polyetheretherketone (PEEK) that matches the characteristics of natural bone.
Regulatory clearance from the FDA enables Curiteva to implant the device in people requiring cervical spinal surgeries, as an alternative to the titanium typically used.
The company said the first-to-market technology was distinctive in the way the interconnected structure promoted a “hydrophilic, bioactive environment for cell attachment, proliferation, and healing in pre-clinical animal and in vitro studies”.
“Our capability to integrate unique design elements… to optimize beneficial material properties such as radiographic assessment and biomechanical load-sharing represents a significant leap forward in the design and development of medical devices,” said Curiteva Vice President of Emerging Technology, Todd Reith in a press statement.
The device is set to launch in key academic centres within the United States. For more information, visit the Curiteva website.
