FDA Clears Expanded Use for NuVasive TLX Interbody System

FDA has cleared a NuVasive 510(k) for the TLX interbody system for use in spinal fusion surgery. The new clearance introduces an expandable 20 degree cage and broader indications for use, including allogeneic bone grafts and in additional levels of the spine. “TLX implants can be placed seamlessly into the disc space due to their low profile, bulleted design,” the company says. “A proprietary inserter allows the surgeon to insert, expand and rapidly post pack the implant through the same instrument, optimizing surgical efficiency. The TLX interbody system provides restoration of sagittal alignment with customizable degrees of lordosis and was designed to induce lordosis in an anatomical fashion, unique to what is currently on the market.” Prior to this expanded clearance, TLX interbodies were available in 15 degree lordotic options and were only indicated for use with allograft, NuVasive adds.