The Monolith corpectomy system (NuVasive) has been granted expanded FDA 510(k) clearance.
The system is now cleared for procedures in the cervical spine, between the C3-C7 vertebral bodies, to treat diseased or damaged vertebral body caused by fractures, tumours, osteomyelitis or to support reconstruction following corpectomy for the decompression of the spinal cord and neural tissue in cervical degenerative disorders, the San Diego-based company said.
The device was initially cleared in 2015 for use in thoracolumbar corpectomy procedures. The system features a monolithic cage made from PEEK and modular endcaps for anatomical personalisation.
“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,” strategy, technology and corporate development president Matt Link said in a press release.
He continued: “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.”
Last month, NuVasive said that it won FDA 510(k) clearance for Cohere porous PEEK implants that are part of its Extreme Lateral Interbody Fusion surgical spinal procedures.