December 10, 2018
NuVasive, Inc. today announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for expanded use of its Monolith® Corpectomy System, providing surgeons with a modular PEEK interbody solution for cervical corpectomy procedures.
NuVasive reports the FDA 510(k) indications for expanded use of the Company’s Monolith Corpectomy System include procedures in the cervical spine (C3-C7 vertebral bodies) to treat a diseased or damaged vertebral body caused by fracture, tumors, osteomyelitis or to support reconstruction following corpectomy performed to achieve decompression of the spinal cord and neural tissue in cervical degenerative disorders.
“Expanding the indicated use of our Monolith Corpectomy System to include cervical corpectomy procedures demonstrates the Company’s continued commitment to expanding our cervical spine interbody portfolio,” said Matt Link, president, Strategy, Technology and Corporate Development for NuVasive. “We are pleased to provide surgeons with a PEEK cervical interbody solution to help round out our cervical portfolio as we continue to advance our mission to improve patient lives.”
NuVasive’s Monolith Corpectomy System was initially cleared by the FDA for indicated use in thoracolumbar corpectomy procedures in 2015, offering a fully modular, imaging-friendly PEEK implant solution. The system is comprised of a monolithic core with modular endcaps that allow surgeons to customize the device to meet the patient’s specific anatomical requirements. The endcaps are available in multiple footprint and lordosis options intended to help maximize endplate coverage while addressing the surgeon’s alignment goals. The Monolith cage is constructed entirely from PEEK and includes radiographic markers, which provides increased clarity in postoperative x-rays and imaging, allowing surgeons to more easily assess fusion following procedures. The cage also includes large central graft apertures designed to help facilitate bony through-growth and fusion.