NuVasive receives FDA 510(k) clearance for corpectomy system intended for cervical spine

NuVasive Inc. announced it received FDA 510(k) clearance for the expanded use of the Monolith corpectomy system, which provides surgeons a modular PEEK interbody solution for cervical corpectomy procedures, according to a release.

"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," Matt Link, president, Strategy, Technology and Corporate Development for NuVasive, said in the release. "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."

According to the release, the indications for the expanded use of the Monolith corpectomy system include procedures in the cervical spine for the treatment of diseased or damaged vertebral body due to fractures, tumors, osteomyelitis or to support reconstruction after a corpectomy to achieve decompression of the spinal cord and neural tissue in cervical degenerative disorders. The corpectomy system has a monolithic core with modular endcaps that lets surgeons customize the device for a patient’s specific anatomical environment. The Monolith cage is composed of PEEK and has radiographic markers that offer clarity to postoperative X-rays and imaging, which provides surgeons easy access to fusion after procedures. It also includes large graft apertures that promote bony through-growth and fusion.

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