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The Romero Cervical Cage consists of an interbody device indicated for use in anterior cervical interbody fusion procedures in skeletally mature patients with cervical disc disease at one or two contiguous levels from the C2 to the T1 disc. Cervical disc disease is defined as intractable radiculopathy and/or myelopathy with herniated disc and/or osteophyte formation on posterior vertebral endplates producing symptomatic nerve root and/or spinal cord compression confirmed by radiographic studies. The Romero Cervical Cage includes cages with and without screw holes. For cages with internal screw holes, the provided screws must be used for internal fixation. The Romero Cervical Cage requires additional supplemental fixation cleared for the cervical spine. The Romero Cervical Cage 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 nonoperative treatment. Patients with previous non-fusion spinal surgery at involved level may be treated with the device.

The Romero Cervical Cage is an anterior cervical interbody device consisting of a PEEK HA or PEEK OPTIMA interbody cage with tantalum radiographic markers and two Titanium (Ti-6Al-4V ELI) fixation screws for cages with screw holes. The PEEK material used conforms to ASTM F2026, the Titanium screws conforms to ASTM F136 and the Tantalum radiographic markers conforms to ASTM F560. The interbody cage is provided in 6° lordosis, anatomic (domed), and lordotic (tapered) profiles in footprints ranging from (WxD) 14x12 to 20x16 (by increments of 2 mm in either direction) and sizes ranging from 5.5 mm (H04) to 14.5 mm (H13) (excluding H04 and H05 in the (WxD) 14x12 to 14x16 footprint for the self-anchored cages). 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 3.5 mm and 4.0 mm diameters and 8-20 mm lengths and feature an anti-backout / tri-lobe screw head design. Both cages and screws are available in separate, single-use sterile packaging.