510(k) · Cleared
ClearedSonoma Anterior Cervical Plate System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Seaspine · KWQ Appliance, Fixation, Spinal Intervertebral Body
Cleared on Oct 9, 2003 after a 69-day review. The FDA summary names its predicate without a number. 19 later devices descend from it.
- Decided
- Oct 9, 2003
- Review
- 69 days
- Class
- Class II
- Product code
- KWQ
- Recalls
- None
- Predicates
- 0
19 later devices descend from it, 3 citing it directly.
- This deviceK032368 Sonoma Anterior Cervical Plate SystemSeaspine · 2003
- Descendant · cites it directly · 16 of its ownK083338 Cardiff Anterior Cervical Plate SystemSeaspine, Inc. · 2009
- Descendant · cites it directly · 15 of its ownK112206 Cardiff Anterior Cervical Plate SystemSeaspine, Inc. · 2012
- Descendant · 2 generations on · 14 of its ownK202064 Admiral ACP SystemSeaSpine Orthopedics Corporation · 2020
- Descendant · 3 generations on · 7 of its ownK211903 Shoreline Threaded TruProfile® PlateSeaSpine Orthopedics Corporation · 2021
- Descendant · 3 generations on · 6 of its ownK212139 Admiral ACP SystemSeaSpine Orthopedics Corporation · 2021
Showing 5 of 19 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 19 · See all- K083338Cardiff Anterior Cervical Plate SystemSeaspine, Inc. · 2009 · cites it directly16descendants
- K112206Cardiff Anterior Cervical Plate SystemSeaspine, Inc. · 2012 · cites it directly15descendants
- K202064Admiral ACP SystemSeaSpine Orthopedics Corporation · 2020 · 2 generations on14descendants
- K211903Shoreline Threaded TruProfile® PlateSeaSpine Orthopedics Corporation · 2021 · 3 generations on7descendants
- K212139Admiral ACP SystemSeaSpine Orthopedics Corporation · 2021 · 3 generations on6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K032368 | Sonoma Anterior Cervical Plate System | Seaspine | 2003 | — |
| +1 | K083338 | Cardiff Anterior Cervical Plate System | Seaspine, Inc. | 2009 | — |
| +1 | K112206 | Cardiff Anterior Cervical Plate System | Seaspine, Inc. | 2012 | — |
| +2 | K202064 | Admiral ACP System | SeaSpine Orthopedics Corporation | 2020 | — |
| +3 | K211903 | Shoreline Threaded TruProfile® Plate | SeaSpine Orthopedics Corporation | 2021 | — |
| +3 | K212139 | Admiral ACP System | SeaSpine Orthopedics Corporation | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2012 | 1 | 0 |
| 2017 | 2 | 0 |
| 2020 | 1 | 0 |
| 2021 | 2 | 0 |
| 2024 | 1 | 0 |
| 2025 | 6 | 0 |
| 2026 | 5 | 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? (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 |
|---|---|---|---|
| * | — | Synthes’ Synthes Anterior Cervical Vertebrae Plates Named without a submission number | |
| * | — | Howmedica Osteonics’ Reflex Anterior Cervical Plate System Named without a submission number |
What descends from it? (19)
See all 193 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, K083338 (Seaspine, Inc., 2009) has gone furthest, with 16 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 | — |
What is it indicated for?
The Sonoma Anterior Cervical Plate System is intended for anterior interbody screw fixation of the cervical spine. This system is indicated for use in the temporary stabilization of the anterior spine from C2 to TI during the development of cervical spinal fusions in patients with: degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies); trauma (including fractures); primary and metastic malignant tumors; deformity (defined as kyphosis, lordosis, or scoliosis); pseudarthrosis; failed previous fusions; and/or spinal cord stenosis and cervical myelopathy.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K032368 · printed Nov 6, 2026
Cite this page
510(k) Report. “K032368: Sonoma 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/K032368
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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