510(k) · Cleared
ClearedAggeris™-C
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 Mar 30, 2022 as substantially equivalent to K103491 (A Johnson & Johnson Company, 2011) after a 68-day review. Its family tree reaches back 4 generations to 1995. 1 later device descends from it.
- Decided
- Mar 30, 2022
- Review
- 68 days
- Class
- Class II
- Product code
- KWQ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K953730 (1995). 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK953730 Codman Anterior Cervical Plate SystemJohnson & Johnson Professionals, Inc. · 1995
- 3 generations backK013877 Codman Slim-Loc SystemCodman & Shurtleff, Inc. · 2001
- 2 generations backK052552 Hybrid Anterior Cervical Plate SystemDepuy Spine, Inc. · 2005 · Recalled
- 1 generation backK103491 Skyline Anterior Cervical Plate SystemA Johnson & Johnson Company · 2011
- This deviceK220182 Aggeris™-CClariance · 2022
- Descendant · cites it directly · 0 of its ownK243904 Elegance® Anterior Cervical plateClariance · 2025 · Recalled
Most influential descendants
Showing 1 of 1 · See all- K243904Elegance® Anterior Cervical plateClariance · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K953730 | Codman Anterior Cervical Plate System | Johnson & Johnson Professionals, Inc. | 1995 | — |
| −3 | K013877 | Codman Slim-Loc System | Codman & Shurtleff, Inc. | 2001 | — |
| −2 | K052552 | Hybrid Anterior Cervical Plate System | Depuy Spine, Inc. | 2005 | 7 |
| −1 | K103491 | Skyline Anterior Cervical Plate System | A Johnson & Johnson Company | 2011 | — |
| 0 (this device) | K220182 | Aggeris™-C | Clariance | 2022 | — |
| +1 | K243904 | Elegance® Anterior Cervical plate | Clariance | 2025 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 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? (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 |
|---|---|---|---|
| * | K103491 | Skyline Anterior Cervical Plate SystemSummary page 4…Appliance, Fixation, Spinal Intervertebral Body Classification Name § 888.3060 Spinal intervertebral body fixation orthosis, Class II Predicate Devices K103491 - SKYLINE Anterior Cervical Plate - Spinal USA, Inc. (primary) K133518 – MaxAn Anterior Cervical Plate System – Zimmer Bi… | 2011 |
| † | K133518 | Maxan Anterior Cervical Plate System | 2014 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K243904 | Elegance® Anterior Cervical plate | 2025 | 0 |
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 27 years and passes through 5 companies; a new generation was cleared every 6.1 years on median.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K243904 (Clariance, 2025) has gone furthest, with 0 descendants of its own.
- 13 other devices also cite its predicate K103491.
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 Aggeris™-C device 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/K220182 · printed Nov 6, 2026
Cite this page
510(k) Report. “K220182: Aggeris™-C.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K220182
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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