NuVasive Inc. (NSDQ:NUVA) said today that it won 510(k) clearance from the FDA for its X-Core mini cervical corpectomy cage, claiming it as the 1st such device cleared for the U.S. market.
The X-Core device is designed to replace vertebrae in the cervical spine (C3 to C7), San Diego-based NuVasive said. It must be used with supplemental fixation such as the company’s Archon Reconstruction corpectomy plate.
“This assembly of best-in-class cervical products into a cohesive procedural offering further reinforces NuVasive’s commitment to providing single-source, integrated procedural solutions to our customers,” president & COO Pat Miles said in prepared remarks. “Combining X-Core Mini VBR and Archon Reconstruction plate provides another excellent example of defining the components necessary to properly address an unmet market need as NuVasive remains focused on becoming number one in spine.”
“The X-Core Mini system allows the surgeon a choice of endcaps and core diameters, ensuring each construct is optimized to best address each patient’s individual surgical needs,” added Dr. Neill Wright of the Barnes Jewish Hospital in St. Louis. “I have used X-Core Mini in degenerative, neoplastic, traumatic, and infectious cases. With so many options of size and endcap, in each case, from the more common single level to the rare five-level corpectomy, the X-Core Mini has fit perfectly and simply. The design of X-Core Mini, from connection of the endcaps to the core, to in-situ expansion, to locking, has proven to be straightforward, reproducible, durable and reliable. The large central channel allows for copious amount of graft material, and the large anterior window allows for augmentation with further graft after insertion and expansion.”