510(k) · Cleared
ClearedAnterior Cervical Plate System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Evolution Spine, LLC · KWQ Appliance, Fixation, Spinal Intervertebral Body
Cleared on Dec 21, 2017 as substantially equivalent to K030866 (Synthes (Usa), 2003) after a 55-day review. Its family tree reaches back 1 generation to 2003. 2 later devices descend from it.
- Decided
- Dec 21, 2017
- Review
- 55 days
- Class
- Class II
- Product code
- KWQ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K030866 (2003). 2 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK030866 Synthes Anterior CSLP SystemSynthes (Usa) · 2003
- This deviceK173375 Anterior Cervical Plate SystemEvolution Spine, LLC · 2017
- Descendant · cites it directly · 1 of its ownK212405 EMERGE™ Anterior Cervical Plate SystemEvolution Spine · 2021
- Descendant · 2 generations on · 0 of its ownK220275 EMERGE Anterior Cervical Plate SystemEvolution Spine · 2022
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 | K030866 | Synthes Anterior CSLP System | Synthes (Usa) | 2003 | — |
| 0 (this device) | K173375 | Anterior Cervical Plate System | Evolution Spine, LLC | 2017 | — |
| +1 | K212405 | EMERGE™ Anterior Cervical Plate System | Evolution Spine | 2021 | — |
| +2 | K220275 | EMERGE Anterior Cervical Plate System | Evolution Spine | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 2022 | 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? (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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K030866 | Synthes Anterior CSLP SystemSummary page 5… ŽĐƵŵĞŶƚĂƚŝŽŶǁĂƐƉƌŽǀŝĚĞĚƚŽĚĞŵŽŶƐƚƌĂƚĞƚŚĂƚƚŚĞ^ƵďũĞĐƚŶƚĞƌŝŽƌĞƌǀŝĐĂůWůĂƚĞ^LJƐƚĞŵŝƐ ƐƵďƐƚĂŶƚŝĂůůLJĞƋƵŝǀĂůĞŶƚƚŽƚŚĞƉƌĞĚŝĐĂƚĞSynthes Anterior ^>P System ;<030866Ϳ͘ TŚĞ^ƵďũĞĐƚĚĞǀŝĐĞŝƐƐƵďƐƚĂŶƚŝĂůůLJĞƋƵŝǀĂůĞŶƚƚŽƚŚĞƉƌĞĚŝĐĂƚĞĚĞǀŝĐĞŝŶŝŶƚĞŶĚĞĚƵƐĞ͕ŝŶĚŝĐĂƚŝŽŶƐĨŽƌ ƵƐĞ͕ŵĂƚĞƌŝĂůƐ͕ ƚĞĐŚ… | 2003 |
| Kept off the family tree | K121514 | FDA’s K121514 is Anodyne Anterior Cervical Plate System Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 2012 |
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 |
|---|---|---|---|
| K212405 | EMERGE™ Anterior Cervical Plate System | 2021 | 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. 2017, 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 Anterior Cervical Plate System is indicated for anterior screw fixation of the cervical spine (C2-C7) as an adjunct to fusion. These implants have been designed to provide stabilization for the treatment of the following indications; degenerative disc disease (defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fractures or dislocations), spinal stenosis, deformity (i.e., kyphosis, lordosis or scoliosis), tumor, pseudarthrosis or failed previous fusion.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K173375 · printed Nov 6, 2026
Cite this page
510(k) Report. “K173375: 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/K173375
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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