510(k) · Cleared
ClearedARIES Anterior Cervical Plate Systems
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
ZheJiang Decans Medical Devices Co., Ltd. · KWQ Appliance, Fixation, Spinal Intervertebral Body
Cleared on May 14, 2026 as substantially equivalent to K021461 (Medtronic Sofamor Danek, 2002) and 3 other predicates after a 254-day review. Its family tree reaches back 9 generations to 1995.
- Decided
- May 14, 2026
- Review
- 254 days
- Class
- Class II
- Product code
- KWQ
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 9 generations to K953730 (1995). 21 ancestors in all. No later device cites it as a predicate yet.
- Root · 9 generations backK953730 Codman Anterior Cervical Plate SystemJohnson & Johnson Professionals, Inc. · 1995
- 5 generations between
- 3 generations backK130640 Atlantis Anterior Cervical Plate SystemMedtronic Sofamor Danek USA, Inc. · 2013
- 2 generations backK141632 Zevo (TM) Anterior Cervical Plate SystemMedtronic Sofamor Danek USA, Inc. · 2014 · Recalled
- 1 generation backK231090 Zevo Anterior Cervical Plate SystemMedtronic Sofamor Danek USA, Inc. · 2023
- This deviceK252776 ARIES Anterior Cervical Plate SystemsZheJiang Decans Medical Devices Co., Ltd. · 2026
Show all 9 generations
- Root · 9 generations backK953730 Codman Anterior Cervical Plate SystemJohnson & Johnson Professionals, Inc. · 1995
- 8 generations backK013877 Codman Slim-Loc SystemCodman & Shurtleff, Inc. · 2001
- 7 generations backK040655 Swift Anterior Cervical Plate SystemDepuy Spine, Inc. · 2004
- 6 generations backK072546 Swift Plus Anterior Cervical Plate SystemDepuy Spine, Inc. · 2007
- 5 generations backK080646 C-Tek Maxan Anterior Cervical Plate SystemBiomet Spine · 2008 · Recalled
- 4 generations backK081038 Atlantis Anterior Cervical Plate SystemMedtronic Sofamor Danek · 2008 · Recalled
- 3 generations backK130640 Atlantis Anterior Cervical Plate SystemMedtronic Sofamor Danek USA, Inc. · 2013
- 2 generations backK141632 Zevo (TM) Anterior Cervical Plate SystemMedtronic Sofamor Danek USA, Inc. · 2014 · Recalled
- 1 generation backK231090 Zevo Anterior Cervical Plate SystemMedtronic Sofamor Danek USA, Inc. · 2023
- This deviceK252776 ARIES Anterior Cervical Plate SystemsZheJiang Decans Medical Devices Co., Ltd. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K953730 | Codman Anterior Cervical Plate System | Johnson & Johnson Professionals, Inc. | 1995 | — |
| −8 | K013877 | Codman Slim-Loc System | Codman & Shurtleff, Inc. | 2001 | — |
| −7 | K040655 | Swift Anterior Cervical Plate System | Depuy Spine, Inc. | 2004 | — |
| −6 | K072546 | Swift Plus Anterior Cervical Plate System | Depuy Spine, Inc. | 2007 | — |
| −5 | K080646 | C-Tek Maxan Anterior Cervical Plate System | Biomet Spine | 2008 | 2 |
| −4 | K081038 | Atlantis Anterior Cervical Plate System | Medtronic Sofamor Danek | 2008 | 3 |
| −3 | K130640 | Atlantis Anterior Cervical Plate System | Medtronic Sofamor Danek USA, Inc. | 2013 | — |
| −2 | K141632 | Zevo (TM) Anterior Cervical Plate System | Medtronic Sofamor Danek USA, Inc. | 2014 | 1 |
| −1 | K231090 | Zevo Anterior Cervical Plate System | Medtronic Sofamor Danek USA, Inc. | 2023 | — |
| 0 (this device) | K252776 | ARIES Anterior Cervical Plate Systems | ZheJiang Decans Medical Devices Co., Ltd. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 2 | 0 |
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2011 | 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? (4)
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 |
|---|---|---|---|
| * | K021461 | Atlantis Vision Anterior Cervical Plate SystemSummary page 5…zation Environment of Use: Healthcare facility/Hospital Single Use: yes Provided status: non-sterile 3. Identification of predicate device(s) Primary predicate device K021461-ATLANTISTM Anterior Cervical Plate System Regulation number: 21CFR888.3060 Regulation name: Spinal intervertebral body fixation o… | 2002 |
| * | K130640 | Atlantis Anterior Cervical Plate SystemSummary page 6…K252776 - Page 2 of 5 Product code: KWQ Common name: appliance, fixation, spinal intervertebral body Review panel: Orthopedic Additional predicate device: K130640-ATLANTISTM Anterior Cervical Plate System Regulation number: 21CFR888.3060 Regulation name: Spinal intervertebral body fixation o… | 2013 |
| * | K103491 | Skyline Anterior Cervical Plate SystemSummary page 6…ntervertebral body fixation orthosis Regulation class: Class II Product code: KWQ Common name: appliance, fixation, spinal intervertebral body Review panel: Orthopedic K103491-SKYLINE® Anterior Cervical Plate System Regulation number: 21CFR888.3060 Regulation name: Spinal intervertebral body fixation ort… | 2011 |
| * | K231090 | Zevo Anterior Cervical Plate SystemSummary page 6…intervertebral body fixation orthosis Regulation class: Class II Product code: KWQ Common name: appliance, fixation, spinal intervertebral body Review panel: Orthopedic K231090-ZEVOTM Anterior Cervical Plate System Regulation number: 21CFR888.3060 Regulation name: Spinal intervertebral body fixation ortho… | 2023 |
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 31 years and passes through 7 companies; a new generation was cleared every 2.9 years on median.
- 6 of the 21 ancestors have a recall of any class.
- 13 other devices also cite its predicate K021461.
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. 2026, 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 ARIES Anterior Cervical Plate Systems is intended for anterior interbody screw fixation from C2-T1 in the cervical spine. The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusions in patients with:
1) Degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies)
2) Trauma (including fractures)
3) Tumors
4) Deformity (defined as kyphosis, lordosis, or scoliosis)
5) Pseudarthrosis, and/or
6) Failed previous fusions
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/K252776 · printed Nov 4, 2026
Cite this page
510(k) Report. “K252776: ARIES Anterior Cervical Plate Systems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K252776
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026