NuVasive, Inc.'s CoRoent Small Interlock system can now be used for "multiple contiguous levels from C2-T1 for anterior cervical discectomy and fusion (ACDF) procedures," after receiving 510(k) clearance from the FDA on November 13, 2019.
The FDA previous cleared the system in September 2016 for only one level.
The company stated in a November 21, 2019 press release that the new indication differentiates the system "compared to other systems on the market cleared for only one- or two-level use." It took the agency a little less than two months to grant the clearance.
The system, according to company and FDA documents, 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 original clearance states the system consists of a PEEK (polyetheretherketone) implant cage with titanium alloy and tantalum radiographic markers, titanium alloy washers, and three titanium alloy bone fixation screws. The devices are manufactured from PEEK-Optima LT-1.
Leonel Hunt, M.D., an orthopedic spine surgeon at Hunt Spine in Los Angeles, California, said a zero-profile interbody implant that can be used in more than two contiguous levels, enables the surgeon "to avoid supplemental fixation which can ultimately reduce operative time."
Company President Matt Link said, "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."
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