Hollywood, Florida-based SpineUp Inc., has received FDA 510(k) Clearance for its Romero Self-Anchored Cervical Cage. The agency also cleared the company's Romero Cervical Cage. The cages are anterior cervical interbody devices indicated for use at one level from the C2-C3 disc to the C7-T1 disc.
According to FDA documents, the devices consist of a PEEK HA or PEEK OPTIMA interbody cage with tantalum radiographic markers and two titanium fixation screws for cages with screw holes.
The two radiographic markers are present on the posterior wall "to confirm position and orientation relative to the AP plane." The bone screws are provided as self-drilling and self-tapping options in 3.5mm and 4.0mm diameters and 8-20mm lengths and feature an anti-backout/tri-lobe screw head design.
The interbody cage is provided in "6º lordosis, anatomic (domed), and lordotic (tapered) profiles in footprints ranging from (WxD) 14x12 to 20x16 (by increments of 2mm in either direction) and sizes ranging from 5.5mm (H04) to 14.5mm (H13) (excluding H04 and H05 in the (WxD) 14x12 to 14x16 footprint for the self-anchored cages).”
The FDA documents state the Romero is designed for use with autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone graft, "to facilitate fusion and is to be implanted via an open, anterior approach. This cervical device is to be used in patients who have had six weeks of non-operative treatment. Patients with previous non-fusion spinal surgery at involved level may be treated with the device."
The FDA found the Romero substantially equivalent to Medtronic's DIVERGENCE Anterior Cervical Fusion System. The company said its device combines features of the Medtronic system, as well as those from Reliance Medical Systems, Alphatec Spine and Centinel Spine. The agency cleared the device in early January, after a little over five months of review.
Philippe Laurito, the company's founder, said he and his colleagues are convinced that the Peek HA-Enhanced technology as well as the 3D titanium printed technology "are the right path for the future of spine surgery."
Back in February 2021, the company announced a technological co-development agreement with the French company, Safe Orthopedics.
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