510(k) · Cleared
ClearedEMERGE Anterior Cervical Plate System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Evolution Spine · KWQ Appliance, Fixation, Spinal Intervertebral Body
Cleared on Mar 18, 2022 as substantially equivalent to K212405 (Evolution Spine, 2021) and 1 other predicate after a 46-day review. Its family tree reaches back 3 generations to 2003.
- Decided
- Mar 18, 2022
- Review
- 46 days
- Class
- Class II
- Product code
- KWQ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K030866 (2003). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK030866 Synthes Anterior CSLP SystemSynthes (Usa) · 2003
- 2 generations backK173375 Anterior Cervical Plate SystemEvolution Spine, LLC · 2017
- 1 generation backK212405 EMERGE™ Anterior Cervical Plate SystemEvolution Spine · 2021
- This deviceK220275 EMERGE Anterior Cervical Plate SystemEvolution Spine · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K030866 | Synthes Anterior CSLP System | Synthes (Usa) | 2003 | — |
| −2 | K173375 | Anterior Cervical Plate System | Evolution Spine, LLC | 2017 | — |
| −1 | K212405 | EMERGE™ Anterior Cervical Plate System | Evolution Spine | 2021 | — |
| 0 (this device) | K220275 | EMERGE Anterior Cervical Plate System | Evolution Spine | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K212405 | EMERGE™ Anterior Cervical Plate SystemSummary page 4…II Product Code: KWQ, Appliance, Fixation, Spinal Intervertebral Body Primary Predicate: EMERGE™ Anterior Cervical Plate System (K212405) Additional Predicate: Atlas Spine V3 Segmental Plating System (K182418) Device Description: The EMERGE™ Anterior Cerv… | 2021 |
| * | K182418 | V3 Segmental Plating SystemSummary page 4…vertebral Body Primary Predicate: EMERGE™ Anterior Cervical Plate System (K212405) Additional Predicate: Atlas Spine V3 Segmental Plating System (K182418) Device Description: The EMERGE™ Anterior Cervical Plate System consists of cervical plates offered in various sizes to accommod… | 2018 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- The line of descent spans 19 years and passes through 3 companies; a new generation was cleared every 3.8 years on median.
- None of the 4 ancestors has a recall.
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. 2022, 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 EMERGE™ Anterior Cervical Plate System is intended for anterior screw fixation to the cervical spine (C2-C7) for the following indications: degenerative disc disease (DDD) (defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumors (primary and metastatic), deformity (kyphosis, lordosis or scoliosis), failed previous fusions (pseudarthrosis), spondylolisthesis, and spinal stenosis. The EMERGE™ Anterior Cervical Plate System is not intended for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic or lumbar spine.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K220275 · printed Nov 6, 2026
Cite this page
510(k) Report. “K220275: EMERGE 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/K220275
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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