510(k) · Cleared
ClearedHexanium® ACIF
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Spinevision, S.A.S. · OVE Intervertebral Fusion Device With Integrated Fixation, Cervical
Cleared on Oct 20, 2020 as substantially equivalent to K190546 (Nexxt Spine, LLC, 2019) and 1 other predicate after a 358-day review. Its family tree reaches back 22 generations to 1984. 1 of the 333 devices in its family, counting itself, has a Class I recall. 14 later devices descend from it.
- Decided
- Oct 20, 2020
- Review
- 358 days
- Class
- Class II
- Product code
- OVE
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 22 generations to K841189 (1984). 318 ancestors in all, the oldest K792352 (1979). 14 later devices descend from it, 2 citing it directly. 1 of the 333 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 backK160125 Cascadia Interbody SystemK2m · 2016
- 2 generations backK171140 Matrixx SystemNexxt Spine, LLC · 2017
- 1 generation backK190546 NEXXT MATRIXX Stand Alone Cervical SystemNexxt Spine, LLC · 2019
- This deviceK193000 Hexanium® ACIFSpinevision, S.A.S. · 2020
- Descendant · cites it directly · 8 of its ownK211111 SureMAX-SA Cervical Standalone SystemAdditive Implants, Inc. · 2021
- Descendant · 2 generations on · 5 of its ownK223105 Tesera-K SC SystemKyocera Medical Technologies, Inc. · 2022
- Descendant · cites it directly · 4 of its ownK221578 Hexanium ACIFSpinevision, S.A.S. · 2022
- Descendant · 2 generations on · 3 of its ownK242260 aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical…Carlsmed, Inc. · 2024
- Descendant · 3 generations on · 3 of its ownK231766 Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI) · 2023
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 backK143616 AccuLIF TL and PL CageStryker Corporation · 2015 · Recalled
- 4 generations backK152304 Tritanium PL CageStryker · 2015 · Recalled
- 3 generations backK160125 Cascadia Interbody SystemK2m · 2016
- 2 generations backK171140 Matrixx SystemNexxt Spine, LLC · 2017
- 1 generation backK190546 NEXXT MATRIXX Stand Alone Cervical SystemNexxt Spine, LLC · 2019
- This deviceK193000 Hexanium® ACIFSpinevision, S.A.S. · 2020
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K073202 Ardis Spacer6 generations back · 2008
Most influential descendants
Showing 5 of 14 · See all- K211111SureMAX-SA Cervical Standalone SystemAdditive Implants, Inc. · 2021 · cites it directly8descendants
- K223105Tesera-K SC SystemKyocera Medical Technologies, Inc. · 2022 · 2 generations on5descendants
- K221578Hexanium ACIFSpinevision, S.A.S. · 2022 · cites it directly4descendants
- K242260aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAMCarlsmed, Inc. · 2024 · 2 generations on3descendants
- K231766Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI) · 2023 · 3 generations on3descendants
View 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 | K143616 | AccuLIF TL and PL Cage | Stryker Corporation | 2015 | 4 |
| −4 | K152304 | Tritanium PL Cage | Stryker | 2015 | 1 |
| −3 | K160125 | Cascadia Interbody System | K2m | 2016 | — |
| −2 | K171140 | Matrixx System | Nexxt Spine, LLC | 2017 | — |
| −1 | K190546 | NEXXT MATRIXX Stand Alone Cervical System | Nexxt Spine, LLC | 2019 | — |
| 0 (this device) | K193000 | Hexanium® ACIF | Spinevision, S.A.S. | 2020 | — |
| +1 | K211111 | SureMAX-SA Cervical Standalone System | Additive Implants, Inc. | 2021 | — |
| +2 | K223105 | Tesera-K SC System | Kyocera Medical Technologies, Inc. | 2022 | — |
| +1 | K221578 | Hexanium ACIF | Spinevision, S.A.S. | 2022 | — |
| +2 | K242260 | aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAM | Carlsmed, Inc. | 2024 | — |
| +3 | K231766 | Skyway Anterior Cervical Plate System | Kyocera Medical Technologies Inc. (KMTI) | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1980 | 1 | 0 |
| 1990 | 1 | 0 |
| 1992 | 2 | 0 |
| 1996 | 6 | 0 |
| 1998 | 1 | 0 |
| 1999 | 2 | 0 |
| 2000 | 2 | 0 |
| 2001 | 12 | 0 |
| 2002 | 10 | 0 |
| 2003 | 16 | 0 |
| 2004 | 25 | 0 |
| 2005 | 19 | 0 |
| 2006 | 10 | 0 |
| 2007 | 16 | 0 |
| 2008 | 45 | 1 |
| 2009 | 28 | 0 |
| 2010 | 17 | 0 |
| 2011 | 26 | 0 |
| 2012 | 16 | 0 |
| 2013 | 14 | 0 |
| 2014 | 16 | 0 |
| 2015 | 6 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 2022 | 3 | 0 |
| 2023 | 2 | 0 |
| 2024 | 2 | 0 |
| 2025 | 3 | 0 |
| 2026 | 3 | 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? (2)
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 |
|---|---|---|---|
| * | K190546 | NEXXT MATRIXX Stand Alone Cervical SystemSummary page 4…Device with integrated fixation, cervical Classification 21 CFR 888.3080: Intervertebral body fusion device Device Panel Orthopedic Primary Predicate K190546 Nexxt Matrixx Stand Alone Cervical System, Nexxt Spine Additional K141314 SCARLET® AC-T Secured Anterior Cervical Cage… | 2019 |
| * | K141314 | Scarlet AC-T Secured Anterior Cervical Cage and Associated InstrumentationSummary page 4…rvertebral body fusion device Device Panel Orthopedic Primary Predicate K190546 Nexxt Matrixx Stand Alone Cervical System, Nexxt Spine Additional K141314 SCARLET® AC-T Secured Anterior Cervical Cage, SPINEART Predicate Device Description The Hexanium® ACIF is a titanium alloy (Ti6… | 2014 |
What descends from it? (14)
See all 142 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 · 6 generations back · ◆ in the 2008 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 36 years and passes through 15 companies; a new generation was cleared every 11 months on median.
- 39 of the 318 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K211111 (Additive Implants, Inc., 2021) has gone furthest, with 8 descendants of its own.
- 3 other devices also cite its predicate K190546.
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. 2020, 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 Hexanium ACIF (Anterior Cervical Interbody Fusion) system is intervertebral body fusion device indicated for use with autogenous bone graft in skeletally mature patients with Degenerative Disc Disease (DDD) at one level from C3-T1. DDD is defined as discogenic neck pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved…
Read the full statement (107 words)
The Hexanium ACIF (Anterior Cervical Interbody Fusion) system is intervertebral body fusion device indicated for use
with autogenous bone graft in skeletally mature patients with Degenerative Disc Disease (DDD) at one level from C3-T1.
DDD is defined as discogenic neck pain with degeneration of the disc confirmed by patient history and radiographic
studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s).
Patients should have received at least 6 weeks of non-operative treatment prior to treatment with Hexanium ACIF system.
This device has to be filled with autogenous bone graft material. This device is implanted via an anterior approach.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K193000 · printed Nov 3, 2026
Cite this page
510(k) Report. “K193000: Hexanium® ACIF.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K193000
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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