NuVasive receives first FDA 510(k) clearance of cervical corpectomy cage


NuVasive has announced the first ever Food and Drug Administration (FDA) 510(k) clearance of a cervical corpectomy cage. The X-Core Mini cervical corpectomy system is an expandable titanium vertebral body replacement device designed to provide enhanced stability following a corpectomy procedure.

The NuVasive X-Core system is a vertebral body replacement device indicated for use in the cervical spine (C3–C7) in skeletally mature patients to replace a diseased or damaged vertebral body caused by tumour, fracture or osteomyelitis, in addition to the reconstruction following a corpectomy performed to achieve decompression of the spinal cord and neural tissues in cervical degenerative disorders.

X-Core Mini is intended to be used with supplemental fixation cleared by the FDA for use in the cervical spine. These implants are intended for use with autograft or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft, as an adjunct to fusion. It is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumours involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion, with bone graft used at the surgeon’s discretion.

“The X-Core Mini system allows the surgeon a choice of endcaps and core diameters, ensuring each construct is optimised to best address each patient’s individual surgical needs,” said Neill Wright, a neurosurgeon practicing at Barnes Jewish Hospital in St Louis, USA. “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.”

X-Core Mini must be used with supplemental fixation cleared by the FDA for use in the cervical spine, which includes NuVasive’s newly released Archon reconstruction corpectomy plate. NuVasive is redefining cervical corpectomy surgery as the Archon-R plate is designed to offer improved biomechanical rigidity and resistance to screw pullout when compared to a traditional two-hole plate construct and is a first-of-its kind indication by the FDA as particularly suited for use following corpectomies for the treatment of tumours and burst fractures.

“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,” said Pat Miles, president and chief operating officer of NuVasive. “Combining X-Core Mini 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.”