# K212358: Romero Cervical Cage

- Pathway: 510(k) (Traditional)
- Applicant: Spineup, Inc.
- Decided: Jan 10, 2022 after 165 days
- Product code: OVE (Intervertebral Fusion Device With Integrated Fixation, Cervical)
- Device class: 2
- Regulation: 21 CFR 888.3080
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 26 generations back to K841189 (1984). 496 ancestors in all.
6 later devices descend from it; 3 cite it directly.
1 of 503 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K141599: Divergence Anterior Cervical Fusion System, Medtronic Sofamor Danek USA, Inc. (2015) Summary page 5.
- K173102: Reliance Cervical IBF System, Reliance Medical Systems, LLC (2017) Summary page 5.
- K202812: IdentiTi Cervical Standalone Interbody System, Alphatec Spine, Inc. (2020) Summary page 5.
- K142079: Stalif Cti, Stalif C, Centinel Spine, Inc. (2014) Summary page 5.

## Most influential descendants
- K240893: ARTFX MEDICAL Cervical PEEK Cages (2024), 4 descendants of its own
- K252781: MSFX Mikron Peek Cages (2025), 1 descendant of its own
- K252686: EffortMed PEEK Cages & Corpectomy Cages (2025), 1 descendant of its own
- K260850: Osteomni Spinal Cages System (2026), 0 descendants of its own
- K260340: HC Biologics Osteopoint Peek Cages, HC Biologics Osteopoint Cervical Peek Cages, HC Biologics Osteopoint Lumbar Peek Cages (2026), 0 descendants of its own

## Indications for use
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 TI 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 non-operative treatment. Patients with previous non-fusion spinal surgery at involved level may be treated with the device.

Source page: https://510kreport.com/device/K212358
Methodology: https://510kreport.com/methodology