NuVasive has received US Food and Drug Administration (FDA) 510(k) clearance for expanded indications for the CoRoent small interlock system. The expanded indication allows for on-label use of the device at multiple contiguous levels from C2-T1 for anterior cervical discectomy and fusion (ACDF) procedures, compared to other systems on the market cleared for only one- or two-level use. ACDF is a commonly performed surgery to address cervical disc degeneration or spinal instability.
“NuVasive’s expanded indications for use of the CoRoent small interlock system represents the first interfixated cervical implant on the market to be cleared for use in more than two level procedures,” said Matt Link, president of NuVasive. “This first-of-its-kind clearance reflects NuVasive’s efforts to further penetrate the cervical market and deliver solutions that address a broader range of spine care.”
The CoRoent Small Interlock system is an anterior cervical interbody fusion system indicated for use in adult patients with cervical disc degeneration and/or cervical spinal instability. The system is a no-profile interfixated device that is implanted entirely within the confines of the vertebral disc space and features a zero-step locking mechanism, a large fusion aperture, angled instrumentation for implantation in difficult anatomical locations and a three-screw implant design allowing for versatile interbody placement.
“The multi-level clearance provides surgeons a zero-profile interbody implant that can be used in more than two contiguous levels, enabling the surgeon to avoid supplemental fixation which can ultimately reduce operative time,” said Leonel Hunt (Hunt Spine, Los Angeles, USA).