MCRA, a distinguished independent clinical research organization (CRO) and advisory firm specializing in medical devices, diagnostics, and biologics, is thrilled to announce its instrumental role in securing FDA 510(k) clearance for Curiteva's Inspire 3D Printed Trabecular PEEK Lumbar Interbody Fusion System with HAFUSE Technology. This clearance represents a significant achievement as Curiteva becomes the first company to receive FDA approval for a 3D printed, fully interconnected porous PEEK structure, utilizing an internally developed Fused Filament Fabrication process and printer.

Curiteva's proprietary printers produce a unique porous scaffolding within the PEEK structure, enhancing its biomechanical strength compared to conventional PEEK implants. This innovative architecture, combined with the patented HAFUSE nano-texturing, creates an ideal biological environment for bone in-growth throughout the implant structure.

Having previously collaborated on the FDA-cleared Inspire Trabecular PEEK Cervical Interbody Fusion System in February 2023, MCRA's Spine Regulatory team partnered with Curiteva on the Inspire 3D Printed Trabecular PEEK Lumbar Interbody Fusion System. Their strategic regulatory expertise facilitated the navigation of the FDA's inquiries and testing requirements, resulting in the FDA 510(k) clearance for the device.

MCRA is proud to have contributed to the groundbreaking project of the Inspire 3D Printed Trabecular PEEK Lumbar Interbody Fusion System with HAFUSE Technology and the subsequent FDA clearance. This innovative device represents the convergence of advanced 3D printing, biomaterial science, and engineering excellence, promising improved surgical solutions for patients undergoing lumbar interbody fusion procedures.

MCRA remains committed to advancing patient care through collaborative efforts and innovative solutions in the medical field.

Source: prnewswire.com

 

 

Report Abuse