510(k) · Cleared
ClearedRomero Cervical Cage
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Spineup, Inc. · OVE Intervertebral Fusion Device With Integrated Fixation, Cervical
Cleared on Jan 10, 2022 as substantially equivalent to K141599 (Medtronic Sofamor Danek USA, Inc., 2015) and 3 other predicates after a 165-day review. Its family tree reaches back 26 generations to 1984. 1 of the 503 devices in its family, counting itself, has a Class I recall. 6 later devices descend from it.
- Decided
- Jan 10, 2022
- Review
- 165 days
- Class
- Class II
- Product code
- OVE
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 26 generations to K841189 (1984). 496 ancestors in all, the oldest K792352 (1979). 6 later devices descend from it, 3 citing it directly. 1 of the 503 devices in this family, counting this one, has a Class I recall.
- Root · 26 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 22 generations between
- 3 generations backK182746 ATEC ALIF and LLIF Spacer SystemAlphatec Spine, Inc. · 2018
- 2 generations backK183705 IdentiTi Porous Ti Interbody SystemAlphatec Spine, Inc. · 2019
- 1 generation backK202812 IdentiTi Cervical Standalone Interbody SystemAlphatec Spine, Inc. · 2020
- This deviceK212358 Romero Cervical CageSpineup, Inc. · 2022
- Descendant · cites it directly · 4 of its ownK240893 ARTFX MEDICAL Cervical PEEK CagesArtfx Medical · 2024
- Descendant · cites it directly · 1 of its ownK252781 MSFX Mikron Peek CagesMikron Makina Sanayi VE Tic. Ltd. Sti. · 2025
- Descendant · 2 generations on · 1 of its ownK252686 EffortMed PEEK Cages & Corpectomy CagesEffortmed, LLC · 2025
- Descendant · 3 generations on · 0 of its ownK260850 Osteomni Spinal Cages SystemOsteomni, Inc. · 2026
- Descendant · 2 generations on · 0 of its ownK260340 HC Biologics Osteopoint Peek Cages, HC Biologics Osteopoint Cervical…HC Biologics, LLC · 2026
Show all 26 generations
- Root · 26 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 25 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 24 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 23 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 22 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 21 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 20 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 19 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 18 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 17 generations backK073291 Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2008
- 16 generations backK094025 Crescent Spinal SystemMedtronic Sofamor Danek · 2010
- 15 generations backK110543 Crescent (R) Spinal System TitaniumMedtronic Sofamor Danek USA, Inc. · 2011
- 14 generations backK121683 Acculif TL CageCoalign Innovations, Inc. · 2012
- 13 generations backK123752 Acculif TL and PL CageCoalign Innovations, Inc. · 2013
- 12 generations backK132505 Acculif TL and PL CageCoalign Innovations, Inc. · 2013 · Recalled
- 11 generations backK141217 Acculif TL and PL CageStryker Corporation · 2014 · Recalled
- 10 generations backK143163 AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers…Stryker Corporation · 2015
- 9 generations backK153782 NuVasive® Lumbar Interbody ImplantsNu Vasive, Incorporated · 2016
- 8 generations backK161230 NuVasive Lumbar Interbody ImplantsNu Vasive, Incorporated · 2016
- 7 generations backK170962 NuVasive® CoRoent® Thoracolumbar SystemNu Vasive, Incorporated · 2017
- 6 generations backK171633 NuVasive TLX Interbody SystemNu Vasive, Incorporated · 2017
- 5 generations backK180480 ATEC Universal Spacer SystemAlphatec Spine, Inc. · 2018
- 4 generations backK181453 ATEC ALIF Spacer SystemAlphatec Spine, Inc. · 2018
- 3 generations backK182746 ATEC ALIF and LLIF Spacer SystemAlphatec Spine, Inc. · 2018
- 2 generations backK183705 IdentiTi Porous Ti Interbody SystemAlphatec Spine, Inc. · 2019
- 1 generation backK202812 IdentiTi Cervical Standalone Interbody SystemAlphatec Spine, Inc. · 2020
- This deviceK212358 Romero Cervical CageSpineup, Inc. · 2022
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K073202 Ardis Spacer8 generations back · 2008
Most influential descendants
Showing 5 of 6 · See all- K240893ARTFX MEDICAL Cervical PEEK CagesArtfx Medical · 2024 · cites it directly4descendants
- K252781MSFX Mikron Peek CagesMikron Makina Sanayi VE Tic. Ltd. Sti. · 2025 · cites it directly1descendant
- K252686EffortMed PEEK Cages & Corpectomy CagesEffortmed, LLC · 2025 · 2 generations on1descendant
- K260850Osteomni Spinal Cages SystemOsteomni, Inc. · 2026 · 3 generations on0descendants
- K260340HC Biologics Osteopoint Peek Cages, HC Biologics Osteopoint Cervical Peek Cages, HC…HC Biologics, LLC · 2026 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −26 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −25 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −24 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −23 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −22 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −21 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −20 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −19 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −18 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −17 | K073291 | Capstone Spinal System | Medtronic Sofamor Danek USA, Inc. | 2008 | — |
| −16 | K094025 | Crescent Spinal System | Medtronic Sofamor Danek | 2010 | — |
| −15 | K110543 | Crescent (R) Spinal System Titanium | Medtronic Sofamor Danek USA, Inc. | 2011 | — |
| −14 | K121683 | Acculif TL Cage | Coalign Innovations, Inc. | 2012 | — |
| −13 | K123752 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | — |
| −12 | K132505 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | 3 |
| −11 | K141217 | Acculif TL and PL Cage | Stryker Corporation | 2014 | 3 |
| −10 | K143163 | AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK… | Stryker Corporation | 2015 | — |
| −9 | K153782 | NuVasive® Lumbar Interbody Implants | Nu Vasive, Incorporated | 2016 | — |
| −8 | K161230 | NuVasive Lumbar Interbody Implants | Nu Vasive, Incorporated | 2016 | — |
| −7 | K170962 | NuVasive® CoRoent® Thoracolumbar System | Nu Vasive, Incorporated | 2017 | — |
| −6 | K171633 | NuVasive TLX Interbody System | Nu Vasive, Incorporated | 2017 | — |
| −5 | K180480 | ATEC Universal Spacer System | Alphatec Spine, Inc. | 2018 | — |
| −4 | K181453 | ATEC ALIF Spacer System | Alphatec Spine, Inc. | 2018 | — |
| −3 | K182746 | ATEC ALIF and LLIF Spacer System | Alphatec Spine, Inc. | 2018 | — |
| −2 | K183705 | IdentiTi Porous Ti Interbody System | Alphatec Spine, Inc. | 2019 | — |
| −1 | K202812 | IdentiTi Cervical Standalone Interbody System | Alphatec Spine, Inc. | 2020 | — |
| 0 (this device) | K212358 | Romero Cervical Cage | Spineup, Inc. | 2022 | — |
| +1 | K240893 | ARTFX MEDICAL Cervical PEEK Cages | Artfx Medical | 2024 | — |
| +1 | K252781 | MSFX Mikron Peek Cages | Mikron Makina Sanayi VE Tic. Ltd. Sti. | 2025 | — |
| +2 | K252686 | EffortMed PEEK Cages & Corpectomy Cages | Effortmed, LLC | 2025 | — |
| +3 | K260850 | Osteomni Spinal Cages System | Osteomni, Inc. | 2026 | — |
| +2 | K260340 | HC Biologics Osteopoint Peek Cages, HC Biologics Osteopoint Cervical Peek… | HC Biologics, LLC | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1980 | 1 | 0 |
| 1990 | 3 | 0 |
| 1992 | 8 | 0 |
| 1993 | 4 | 0 |
| 1994 | 2 | 0 |
| 1995 | 4 | 0 |
| 1996 | 7 | 0 |
| 1997 | 7 | 0 |
| 1998 | 6 | 0 |
| 1999 | 7 | 0 |
| 2000 | 10 | 0 |
| 2001 | 17 | 0 |
| 2002 | 16 | 0 |
| 2003 | 23 | 0 |
| 2004 | 32 | 0 |
| 2005 | 27 | 0 |
| 2006 | 17 | 0 |
| 2007 | 21 | 0 |
| 2008 | 55 | 1 |
| 2009 | 34 | 0 |
| 2010 | 24 | 0 |
| 2011 | 33 | 0 |
| 2012 | 23 | 0 |
| 2013 | 24 | 0 |
| 2014 | 24 | 0 |
| 2015 | 18 | 0 |
| 2016 | 8 | 0 |
| 2017 | 9 | 0 |
| 2018 | 3 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 2 | 0 |
| 2026 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
1 device in this family has a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new OVE device
- #1 K241846 E3D™-C Interbody Systemscore 32.1 · 32 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (4)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K141599 | Divergence Anterior Cervical Fusion SystemSummary page 5…Page 2 of 2 PREDICATES Romero Cervical Cage is substantially equivalent to the Medtronic DIVERGENCETM Anterior Cervical Fusion System (K141599). The Romero Cervical Cage is provided sterile. The subject and predicate devices have identical technological characteristics. S… | 2015 |
| * | K173102 | Reliance Cervical IBF SystemSummary page 5…Medtronic Sofamor OVE - Intervertebral body fusion (Primary) Anterior Cervical Danek USA, Inc. device Fusion System K173102 Reliance Cervical Reliance Medical ODP, OVE - Intervertebral body (Additional) IBF System… | 2017 |
| * | K202812 | IdentiTi Cervical Standalone Interbody SystemSummary page 5…Reliance Cervical Reliance Medical ODP, OVE - Intervertebral body (Additional) IBF System Systems, LLC fusion device K202812 IdentiTi TM Cervical Alphatec Spine, Inc. OVE - Intervertebral body fusion (Additional) Standalone Interbod… | 2020 |
| * | K142079 | Stalif Cti, Stalif CSummary page 5…al Alphatec Spine, Inc. OVE - Intervertebral body fusion (Additional) Standalone Interbody device System K142079 STALIF C ® Centinel Spine, Inc. OVE - Intervertebral body fusion (Additional)… | 2014 |
What descends from it? (6)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K073202Ardis SpacerAbbott Spine, Inc. · 2008 · 8 generations back · ◆ in the 2008 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 38 years and passes through 14 companies; a new generation was cleared every 10 months on median.
- 60 of the 496 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K240893 (Artfx Medical, 2024) has gone furthest, with 4 descendants of its own.
- 2 other devices also cite its predicate K141599.
How does its category compare?
All OVE devicesOVE Intervertebral Fusion Device With Integrated Fixation, Cervical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
FDA decisions per year · OVE
10in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OVE
105in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OVE
2in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OVE
132in 2025
MAUDE reports naming product code OVE, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 0 | 0 |
| 2008 | 4 | 131 | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 4 | 210 | 0 | 2 |
| 2011 | 8 | 139 | 0 | 19 |
| 2012 | 7 | 125 | 0 | 59 |
| 2013 | 5 | 71 | 1 | 250 |
| 2014 | 11 | 168 | 1 | 150 |
| 2015 | 12 | 113 | 1 | 173 |
| 2016 | 15 | 149 | 1 | 145 |
| 2017 | 9 | 100 | 1 | 134 |
| 2018 | 7 | 105 | 0 | 210 |
| 2019 | 7 | 87 | 0 | 169 |
| 2020 | 13 | 149 | 0 | 162 |
| 2021 | 10 | 93 | 2 | 186 |
| 2022 | 10 | 144 | 0 | 200 |
| 2023 | 16 | 97 | 0 | 148 |
| 2024 | 6 | 56 | 0 | 142 |
| 2025 | 10 | 105 | 0 | 132 |
| 2026 | 13 | 66 | 0 | — |
What is it indicated for?
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…
Read the full statement (177 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K212358 · printed Nov 6, 2026
Cite this page
510(k) Report. “K212358: Romero Cervical Cage.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K212358
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026