510(k) · Cleared
ClearedAQUA Laminoplasty Systems
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
ZheJiang Decans Medical Devices Co., Ltd. · NQW Orthosis, Spine, Plate, Laminoplasty, Metal
Cleared on May 27, 2026 as substantially equivalent to K212428 (Medtronic Sofamor Danek, 2021) and 3 other predicates after a 254-day review. Its family tree reaches back 4 generations to 1976.
- Decided
- May 27, 2026
- Review
- 254 days
- Class
- Class II
- Product code
- NQW
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 4 generations to K761228 (1976). 15 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK761228 Luhr Mandibular Compression-Screw SystemHowmedica Corp. · 1976
- 3 generations backK963741 Leibinger Luhr Small Craniomaxillofacial Bone ScrewsHowmedica Leibinger, Inc. · 1997
- 2 generations backK032534 Synthes AfsSynthes Spine · 2004
- 1 generation backK091994 Mountaineer Laminoplasty SystemDepuy Spine, Inc. · 2010
- This deviceK252930 AQUA Laminoplasty 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 |
|---|---|---|---|---|---|
| −4 | K761228 | Luhr Mandibular Compression-Screw System | Howmedica Corp. | 1976 | — |
| −3 | K963741 | Leibinger Luhr Small Craniomaxillofacial Bone Screws | Howmedica Leibinger, Inc. | 1997 | — |
| −2 | K032534 | Synthes Afs | Synthes Spine | 2004 | — |
| −1 | K091994 | Mountaineer Laminoplasty System | Depuy Spine, Inc. | 2010 | — |
| 0 (this device) | K252930 | AQUA Laminoplasty Systems | ZheJiang Decans Medical Devices Co., Ltd. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1986 | 2 | 0 |
| 1988 | 1 | 0 |
| 1991 | 1 | 0 |
| 1994 | 1 | 0 |
| 1996 | 2 | 0 |
| 2005 | 1 | 0 |
| 2019 | 1 | 0 |
| 2021 | 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 NQW? 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 NQW device
- #1 K243137 Curiteva Porous PEEK Laminoplasty Systemscore 13.1 · 7 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 |
|---|---|---|---|
| * | K212428 | Centerpiece Plate Fixation SystemSummary page 6…K252930- Page 2 of 3 Manufacturer Medtronic Sofamor Danek 510 (k) K212428 Regulation number 21CFR888.3050 Regulation name Spinal interlaminal fixation orthosis… | 2021 |
| * | K091994 | Mountaineer Laminoplasty SystemSummary page 6…Fixation System System Laminoplasty (AFS) System 510 (k) K091994 K191169 K032534 Manufacturer DePuy Spine, Inc. NuVasive, Synthes Spine… | 2010 |
| * | K191169 | NuVasive® Camber Laminoplasty SystemSummary page 6…System Laminoplasty (AFS) System 510 (k) K091994 K191169 K032534 Manufacturer DePuy Spine, Inc. NuVasive, Synthes Spine… | 2019 |
| * | K032534 | Synthes AfsSummary page 6…Laminoplasty (AFS) System 510 (k) K091994 K191169 K032534 Manufacturer DePuy Spine, Inc. NuVasive, Synthes Spine… | 2004 |
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 50 years and passes through 5 companies; a new generation was cleared every 16.4 years on median.
- 1 of the 15 ancestors has a recall of any class.
How does its category compare?
All NQW devicesNQW Orthosis, Spine, Plate, Laminoplasty, Metal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · NQW
2in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · NQW
84in 2013
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NQW
No recall names NQW since 2007.
Adverse event reports per year · NQW
33in 2025
MAUDE reports naming product code NQW, 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 | 0 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 2 | — | 0 | 2 |
| 2010 | 3 | 120 | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 4 | 120 | 0 | 1 |
| 2013 | 3 | 84 | 0 | 49 |
| 2014 | 0 | — | 0 | 5 |
| 2015 | 1 | — | 0 | 11 |
| 2016 | 2 | — | 0 | 7 |
| 2017 | 1 | — | 0 | 19 |
| 2018 | 2 | — | 0 | 5 |
| 2019 | 2 | — | 0 | 8 |
| 2020 | 0 | — | 0 | 2 |
| 2021 | 1 | — | 0 | 7 |
| 2022 | 0 | — | 0 | 16 |
| 2023 | 2 | — | 0 | 5 |
| 2024 | 2 | — | 0 | 15 |
| 2025 | 0 | — | 0 | 33 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The AQUA Laminoplasty Systems is intended for use in the lower cervical and upper thoracic spine (C3 to T3) in laminoplasty procedures. The AQUA Laminoplasty Systems is used to hold the graft material in place in order to prevent the graft material from expulsion or impinging the spinal cord.
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/K252930 · printed Nov 5, 2026
Cite this page
510(k) Report. “K252930: AQUA Laminoplasty Systems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K252930
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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