NuVasive received FDA 510(k) clearance for expanded use of its Monolith Corpectomy System.
Here are five insights:
1. With the expanded approval, NuVasive introduced a fully modular PEEK implant for the cervical spine.
2. NuVasvie's Monolith Corpectomy System is designed to treat diseased or damaged vertebral caused by fractures, tumors or osteomyelitis. The system also supports reconstruction following corpectomy procedures.
3. The Monolith Corpectomy System was first cleared for thoracolumbar corpectomy procedures in 2015. The system offered a fully modular, imaging-friendly PEEK implant system.
4. The Monolith cage is entirely PEEK-based. It features radiographic markers to provide increased clarity in postoperative X-rays and imaging.
5. "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," said NuVasive's President of Strategy, Technology and Corporate Development Matt Link.