510(k) · Cleared
ClearedEbi Anterior Cervical Plate System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ebi, L.P. · KWQ Appliance, Fixation, Spinal Intervertebral Body
Cleared on Jul 12, 2000 after a 28-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 13 later devices descend from it.
- Decided
- Jul 12, 2000
- Review
- 28 days
- Class
- Class II
- Product code
- KWQ
- Recalls
- None
- Predicates
- 0
13 later devices descend from it, 5 citing it directly.
- This deviceK001794 Ebi Anterior Cervical Plate SystemEbi, L.P. · 2000
- Descendant · cites it directly · 4 of its ownK173099 Fortis and Hana Anterior Cervical Plate SystemHuvexel Co., Ltd. · 2017
- Descendant · 2 generations on · 2 of its ownK222572 FORTIS and HANA Anterior Cervical Plate System, Rex Anterior…Dio Medical Corporation · 2022
- Descendant · cites it directly · 2 of its ownK190666 CYGNUS™ Anterior Cervical Plate SystemMiRus, LLC · 2019
- Descendant · cites it directly · 2 of its ownK112809 Blue Mountain Cervical PlateQualgenix, LLC · 2012
- Descendant · 2 generations on · 1 of its ownK220441 CYGNUS™ MoRe Anterior Cervical Plate SystemMiRus, LLC · 2022
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · See all- K173099Fortis and Hana Anterior Cervical Plate SystemHuvexel Co., Ltd. · 2017 · cites it directly4descendants
- K222572FORTIS and HANA Anterior Cervical Plate System, Rex Anterior Cervical Plate System, and…Dio Medical Corporation · 2022 · 2 generations on2descendants
- K190666CYGNUS™ Anterior Cervical Plate SystemMiRus, LLC · 2019 · cites it directly2descendants
- K112809Blue Mountain Cervical PlateQualgenix, LLC · 2012 · cites it directly2descendants
- K220441CYGNUS™ MoRe Anterior Cervical Plate SystemMiRus, LLC · 2022 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K001794 | Ebi Anterior Cervical Plate System | Ebi, L.P. | 2000 | — |
| +1 | K173099 | Fortis and Hana Anterior Cervical Plate System | Huvexel Co., Ltd. | 2017 | — |
| +2 | K222572 | FORTIS and HANA Anterior Cervical Plate System, Rex Anterior Cervical Plate… | Dio Medical Corporation | 2022 | — |
| +1 | K190666 | CYGNUS™ Anterior Cervical Plate System | MiRus, LLC | 2019 | — |
| +1 | K112809 | Blue Mountain Cervical Plate | Qualgenix, LLC | 2012 | — |
| +2 | K220441 | CYGNUS™ MoRe Anterior Cervical Plate System | MiRus, LLC | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2022 | 3 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in KWQ? 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 KWQ device
- #1 K233640 Segmental Plating System (SPS);IdentiTi SPS…score 21.9 · 31 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (13)
See all 135 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K173099 (Huvexel Co., Ltd., 2017) has gone furthest, with 4 descendants of its own.
How does its category compare?
All KWQ devicesKWQ Appliance, Fixation, Spinal Intervertebral Body: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KWQ
7in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KWQ
64in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KWQ
1in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KWQ
248in 2025
MAUDE reports naming product code KWQ, 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 | 27 | 101 | 2 | 288 |
| 2008 | 32 | 70 | 33 | 348 |
| 2009 | 23 | 90 | 35 | 355 |
| 2010 | 23 | 104 | 2 | 691 |
| 2011 | 22 | 95 | 5 | 415 |
| 2012 | 26 | 90 | 7 | 544 |
| 2013 | 22 | 88 | 6 | 796 |
| 2014 | 17 | 124 | 0 | 546 |
| 2015 | 25 | 102 | 2 | 562 |
| 2016 | 15 | 121 | 9 | 502 |
| 2017 | 20 | 67 | 8 | 492 |
| 2018 | 22 | 95 | 1 | 341 |
| 2019 | 26 | 81 | 0 | 298 |
| 2020 | 26 | 55 | 0 | 400 |
| 2021 | 17 | 59 | 0 | 591 |
| 2022 | 18 | 85 | 0 | 392 |
| 2023 | 16 | 59 | 0 | 320 |
| 2024 | 17 | 64 | 0 | 419 |
| 2025 | 7 | 64 | 0 | 248 |
| 2026 | 10 | 76 | 0 | — |
https://510kreport.com/device/K001794 · printed Nov 6, 2026
Cite this page
510(k) Report. “K001794: Ebi Anterior Cervical Plate System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K001794
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026