510(k) · Cleared
Recalled · Class II · 2026Elegance® Anterior Cervical plate
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Clariance · KWQ Appliance, Fixation, Spinal Intervertebral Body
Cleared on Jan 14, 2025 as substantially equivalent to K220182 (Clariance, 2022) after a 26-day review. Its family tree reaches back 5 generations to 1995. It has been recalled once.
- Decided
- Jan 14, 2025
- Review
- 26 days
- Class
- Class II
- Product code
- KWQ
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 5 generations to K953730 (1995). No later device cites it as a predicate yet.
- Root · 5 generations backK953730 Codman Anterior Cervical Plate SystemJohnson & Johnson Professionals, Inc. · 1995
- 4 generations backK013877 Codman Slim-Loc SystemCodman & Shurtleff, Inc. · 2001
- 3 generations backK052552 Hybrid Anterior Cervical Plate SystemDepuy Spine, Inc. · 2005 · Recalled
- 2 generations backK103491 Skyline Anterior Cervical Plate SystemA Johnson & Johnson Company · 2011
- 1 generation backK220182 Aggeris™-CClariance · 2022
- This deviceK243904 Elegance® Anterior Cervical plateClariance · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K953730 | Codman Anterior Cervical Plate System | Johnson & Johnson Professionals, Inc. | 1995 | — |
| −4 | K013877 | Codman Slim-Loc System | Codman & Shurtleff, Inc. | 2001 | — |
| −3 | K052552 | Hybrid Anterior Cervical Plate System | Depuy Spine, Inc. | 2005 | 7 |
| −2 | K103491 | Skyline Anterior Cervical Plate System | A Johnson & Johnson Company | 2011 | — |
| −1 | K220182 | Aggeris™-C | Clariance | 2022 | — |
| 0 (this device) | K243904 | Elegance® Anterior Cervical plate | Clariance | 2025 | — |
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? (1)
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 |
|---|---|---|---|
| * | K220182 | Aggeris™-CSummary page 5…sification Name: Spinal intervertebral body fixation orthosis, 21 CFR § 888.3060 Regulatory Class: Class II Product Code: KWQ Predicate Device: Aggeris™-C, CLARIANCE (K220182) Device Description The Elegance® Anterior Cervical plate is designed for use as a cervical plate system. The devi… | 2022 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 20, 2026 | Class II | Z-1821-2026 | Process change control | Due to a quality issue regarding the presence of burr on the finished cervical plate product. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 30 years and passes through 5 companies; a new generation was cleared every 5.3 years on median.
- 1 of the 5 ancestors has a recall of any class.
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. 2025, 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 Elegance® Anterior Cervical plate is intended for anterior fixation to the cervical spine from C2 to C7. The specific clinical indications include:
1. Degenerative disc disease (defined as back pain of discogenic origin with degenerative disc confirmed by patient history and radiographic studies)
2. Spondylolisthesis
3. Spinal stenosis
4. Deformities (i.e., scoliosis, kyphosis, and/or lordosis)
5. Pseudoarthrosis
6. Revision of previous surgery
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K243904 · printed Nov 6, 2026
Cite this page
510(k) Report. “K243904: Elegance® Anterior Cervical plate.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K243904
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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