510(k) · Cleared
ClearedAEON-C™ Stand Alone System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dio Medical, Inc. · OVE Intervertebral Fusion Device With Integrated Fixation, Cervical
Cleared on Dec 20, 2022 as substantially equivalent to K191477 (Huvexel Co., Ltd., 2019) after a 77-day review. Its family tree reaches back 22 generations to 1984. 1 of the 348 devices in its family, counting itself, has a Class I recall. 2 later devices descend from it.
- Decided
- Dec 20, 2022
- Review
- 77 days
- Class
- Class II
- Product code
- OVE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 22 generations to K841189 (1984). 345 ancestors in all, the oldest K792352 (1979). 2 later devices descend from it, 1 citing it directly. 1 of the 348 devices in this family, counting this one, has a Class I recall.
- Root · 22 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 18 generations between
- 3 generations backK170235 Lucent®Spinal Elements, Inc. · 2017
- 2 generations backK181837 Spinal Elements Ti-Bond coated devicesSpinal Elements, Inc. · 2018
- 1 generation backK191477 AEON-C Stand Alone SystemHuvexel Co., Ltd. · 2019
- This deviceK223140 AEON-C™ Stand Alone SystemDio Medical, Inc. · 2022
- Descendant · cites it directly · 1 of its ownK232877 FaSet Fixation System, UNITY Sacroiliac Joint Fixation System, Huvex…K&J Consulting Corporation · 2023
- Descendant · 2 generations on · 0 of its ownK250335 IVA & AEON Cervical and Lumbar Cage SystemK&J Consulting · 2025
Show all 22 generations
- Root · 22 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 21 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 20 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 19 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 18 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 17 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 16 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 15 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 14 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 13 generations backK073291 Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2008
- 12 generations backK094025 Crescent Spinal SystemMedtronic Sofamor Danek · 2010
- 11 generations backK110543 Crescent (R) Spinal System TitaniumMedtronic Sofamor Danek USA, Inc. · 2011
- 10 generations backK121683 Acculif TL CageCoalign Innovations, Inc. · 2012
- 9 generations backK123752 Acculif TL and PL CageCoalign Innovations, Inc. · 2013
- 8 generations backK132505 Acculif TL and PL CageCoalign Innovations, Inc. · 2013 · Recalled
- 7 generations backK141217 Acculif TL and PL CageStryker Corporation · 2014 · Recalled
- 6 generations backK143163 AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers…Stryker Corporation · 2015
- 5 generations backK151773 CONCORDE Bullet Lumbar Interbody SystemMedos International SARL · 2015
- 4 generations backK162327 COUGAR® LS Lateral Cage System and COUGAR® SystemMedos International SARL · 2016
- 3 generations backK170235 Lucent®Spinal Elements, Inc. · 2017
- 2 generations backK181837 Spinal Elements Ti-Bond coated devicesSpinal Elements, Inc. · 2018
- 1 generation backK191477 AEON-C Stand Alone SystemHuvexel Co., Ltd. · 2019
- This deviceK223140 AEON-C™ Stand Alone SystemDio Medical, Inc. · 2022
Class I recalls in this family
- K073202 Ardis Spacer5 generations back · 2008
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −22 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −21 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −20 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −19 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −18 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −17 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −16 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −15 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −14 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −13 | K073291 | Capstone Spinal System | Medtronic Sofamor Danek USA, Inc. | 2008 | — |
| −12 | K094025 | Crescent Spinal System | Medtronic Sofamor Danek | 2010 | — |
| −11 | K110543 | Crescent (R) Spinal System Titanium | Medtronic Sofamor Danek USA, Inc. | 2011 | — |
| −10 | K121683 | Acculif TL Cage | Coalign Innovations, Inc. | 2012 | — |
| −9 | K123752 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | — |
| −8 | K132505 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | 3 |
| −7 | K141217 | Acculif TL and PL Cage | Stryker Corporation | 2014 | 3 |
| −6 | K143163 | AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK… | Stryker Corporation | 2015 | — |
| −5 | K151773 | CONCORDE Bullet Lumbar Interbody System | Medos International SARL | 2015 | — |
| −4 | K162327 | COUGAR® LS Lateral Cage System and COUGAR® System | Medos International SARL | 2016 | — |
| −3 | K170235 | Lucent® | Spinal Elements, Inc. | 2017 | — |
| −2 | K181837 | Spinal Elements Ti-Bond coated devices | Spinal Elements, Inc. | 2018 | — |
| −1 | K191477 | AEON-C Stand Alone System | Huvexel Co., Ltd. | 2019 | — |
| 0 (this device) | K223140 | AEON-C™ Stand Alone System | Dio Medical, Inc. | 2022 | — |
| +1 | K232877 | FaSet Fixation System, UNITY Sacroiliac Joint Fixation System, Huvex… | K&J Consulting Corporation | 2023 | — |
| +2 | K250335 | IVA & AEON Cervical and Lumbar Cage System | K&J Consulting | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1980 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 1998 | 3 | 0 |
| 1999 | 6 | 0 |
| 2000 | 3 | 0 |
| 2001 | 11 | 0 |
| 2002 | 9 | 0 |
| 2003 | 17 | 0 |
| 2004 | 27 | 0 |
| 2005 | 21 | 0 |
| 2006 | 11 | 0 |
| 2007 | 17 | 0 |
| 2008 | 46 | 1 |
| 2009 | 27 | 0 |
| 2010 | 18 | 0 |
| 2011 | 27 | 0 |
| 2012 | 17 | 0 |
| 2013 | 18 | 0 |
| 2014 | 19 | 0 |
| 2015 | 10 | 0 |
| 2016 | 5 | 0 |
| 2017 | 3 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 0 |
| 2025 | 1 | 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? (1)
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 |
|---|---|---|---|
| * | K191477 | AEON-C Stand Alone SystemSummary page 5…a cervical intervertebral fusion device. Predicate Primary predicate: Device: Huvexel Co. Ltd. - AEON-C™ Stand Alone System (K191477) Substantial The AEON-C™ Stand Alone System is identical to the predicate Equivalence: device and is as safe an… | 2019 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K232877 | FaSet Fixation System, UNITY Sacroiliac Joint Fixation System, Huvex Interspinous… | 2023 | 1 |
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 · 5 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 15 companies; a new generation was cleared every 12 months on median.
- 40 of the 345 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K232877 (K&J Consulting Corporation, 2023) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K191477.
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 AEON-C™ Stand Alone System is a stand-alone anterior cervical intervertebral fusion device indicated for use in skeletally mature patients with degenerative disc disease (DDD) with accompanying radicular symptoms at one or two contiguous levels from C2-T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. The AEON-C™ Stand Alone System should be packed with autograft and/or allograft…
Read the full statement (100 words)
The AEON-C™ Stand Alone System is a stand-alone anterior cervical intervertebral fusion device indicated for use in
skeletally mature patients with degenerative disc disease (DDD) with accompanying radicular symptoms at one or two
contiguous levels from C2-T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and
radiographic studies. The AEON-C™ Stand Alone System should be packed with autograft and/or allograft comprised of
cancellous, cortical and/or corticocancellous bone graft and implanted with an anterior approach. Patients should receive
at least six (6) weeks of non-operative treatment prior to treatment with a cervical intervertebral fusion device.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K223140 · printed Nov 6, 2026
Cite this page
510(k) Report. “K223140: AEON-C™ Stand Alone System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K223140
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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