NuVasive Gains FDA Clearance for Monolith Corpectomy

By Julie A. Vetalice

NuVasive received FDA 510(k) clearance to market an expanded indication for use of its Monolith® modular PEEK corpectomy system in the cervical spine to treat damage caused by fracture, tumors and osteomyelitis or to support reconstruction following corpectomy performed to achieve decompression of the spinal cord and neural tissue in cervical degenerative disorders.

Monolith gained initial clearance in 2015 for thoracolumbar corpectomy. It comprises a monolithic core with modular endcaps that can be customized to patient anatomy. The cage is made from PEEK and includes radiographic markers, and features large central graft apertures to help facilitate bony through-growth and fusion.

Source: NuVasive, Inc.

Product Labels: Spinal Fusion

Tags: 510(k) Clearance, Regulatory