510(k) · Cleared
ClearedCYGNUS™ Anterior Cervical Plate System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
MiRus, LLC · KWQ Appliance, Fixation, Spinal Intervertebral Body
Cleared on May 9, 2019 as substantially equivalent to K000742 (Synthes Spine, 2000) and 2 other predicates after a 55-day review. Its family tree reaches back 1 generation to 1998. 2 later devices descend from it.
- Decided
- May 9, 2019
- Review
- 55 days
- Class
- Class II
- Product code
- KWQ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K974706 (1998). 3 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK974706 Aesculap Abc Cervical Plating SystemAesculap, Inc. · 1998
- This deviceK190666 CYGNUS™ Anterior Cervical Plate SystemMiRus, LLC · 2019
- Descendant · cites it directly · 1 of its ownK220441 CYGNUS™ MoRe Anterior Cervical Plate SystemMiRus, LLC · 2022
- Descendant · 2 generations on · 0 of its ownK241175 MiRus MoRe Lumbar Plating SystemMiRus, LLC · 2024
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 |
|---|---|---|---|---|---|
| −1 | K974706 | Aesculap Abc Cervical Plating System | Aesculap, Inc. | 1998 | — |
| 0 (this device) | K190666 | CYGNUS™ Anterior Cervical Plate System | MiRus, LLC | 2019 | — |
| +1 | K220441 | CYGNUS™ MoRe Anterior Cervical Plate System | MiRus, LLC | 2022 | — |
| +2 | K241175 | MiRus MoRe Lumbar Plating System | MiRus, LLC | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
| 2024 | 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.
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? (3)
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 |
|---|---|---|---|
| * | K000742 | Synthes Anterior CSLP SystemSummary page 4…bmission Type Traditional 510(k) V. PREDICATE DEVICE Primary: Synthes CSLP System (K000742) Additional: EBI Anterior Cervical Plate (K00… | 2000 |
| * | K001794 | Ebi Anterior Cervical Plate SystemSummary page 4…Synthes CSLP System (K000742) Additional: EBI Anterior Cervical Plate (K001794) Aesculap ABC Plate (K974706) Reference:… | 2000 |
| * | K974706 | Aesculap Abc Cervical Plating SystemSummary page 4…Additional: EBI Anterior Cervical Plate (K001794) Aesculap ABC Plate (K974706) Reference: MiRus Atlas Plating System (K1904… | 1998 |
| † | K190415 | ATLAS Plating System | 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 |
|---|---|---|---|
| K220441 | CYGNUS™ MoRe Anterior Cervical Plate System | 2022 | 1 |
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?
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. 2019, this device’s year, is highlighted.
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 | — |
What is it indicated for?
The CYGNUS™ Anterior Cervical Plate System is a spinal intervertebral body fixation orthosis which is intended to provide temporary immobilization and stabilization of the anterior spine during the development of cervical spinal fusions (C2 to C7) in patients with: (1) Degenerative disc disease, DDD (as defined by neck pain of discogenic origin with degeneration of disc confirmed by patient history and radiographic studies); (2) Spondylolisthesis; (3) Trauma (including fractures or dislocations); (4) Spinal cord stenosis; (5) Deformity or curvatures (i.e. kyphosis, lordosis and/or scoliosis); (6) Tumors; (7) Pseudarthrosis; (8) Failed previous fusions.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K190666 · printed Nov 6, 2026
Cite this page
510(k) Report. “K190666: CYGNUS™ 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/K190666
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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