510(k) · Cleared
ClearedNuVasive® Camber Laminoplasty System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nu Vasive, Incorporated · NQW Orthosis, Spine, Plate, Laminoplasty, Metal
Cleared on Jul 3, 2019 as substantially equivalent to K050082 (Medtronic Sofamor Danek, Inc., 2005) after a 63-day review. Its family tree reaches back 2 generations to 1985. 1 later device descends from it.
- Decided
- Jul 3, 2019
- Review
- 63 days
- Class
- Class II
- Product code
- NQW
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K850631 (1985). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK850631 Kirschner Orthopedic Wire, Eyelet Cerclage WiresKirschner Medical Corp. · 1985
- 1 generation backK050082 Centerpiece Plate Fixation SystemMedtronic Sofamor Danek, Inc. · 2005
- This deviceK191169 NuVasive® Camber Laminoplasty SystemNu Vasive, Incorporated · 2019
- Descendant · cites it directly · 0 of its ownK252930 AQUA Laminoplasty SystemsZheJiang Decans Medical Devices Co., Ltd. · 2026
Most influential descendants
Showing 1 of 1 · See all- K252930AQUA Laminoplasty SystemsZheJiang Decans Medical Devices Co., Ltd. · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K850631 | Kirschner Orthopedic Wire, Eyelet Cerclage Wires | Kirschner Medical Corp. | 1985 | — |
| −1 | K050082 | Centerpiece Plate Fixation System | Medtronic Sofamor Danek, Inc. | 2005 | — |
| 0 (this device) | K191169 | NuVasive® Camber Laminoplasty System | Nu Vasive, Incorporated | 2019 | — |
| +1 | K252930 | AQUA Laminoplasty Systems | ZheJiang Decans Medical Devices Co., Ltd. | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 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? (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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K1091623 | NuVasive® Laminoplasty Fixation System & LeVerage LFS System Number could not be read Summary page 4…NuVasive® Camber Laminoplasty System is substantially equivalent to the primary predicate device, NuVasive® Laminoplasty Fixation System & LeVerage LFS System (K1091623), and additional predicate Medtronic Centerpiece Plate Fixation System (K050082). NuVasive® VuePoint® II OCT System (K180198… | |
| * | K050082 | Centerpiece Plate Fixation SystemSummary page 4…redicate device, NuVasive® Laminoplasty Fixation System & LeVerage LFS System (K1091623), and additional predicate Medtronic Centerpiece Plate Fixation System (K050082). NuVasive® VuePoint® II OCT System (K180198) and NuVasive Affix II Spinous Process Plate System (K132411) are also used as… | 2005 |
| † | K180198 | NuVasive® VuePoint® II OCT System | 2018 |
| † | K132411 | Affix II Spinous Process Plate System | 2013 |
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 |
|---|---|---|---|
| K252930 | AQUA Laminoplasty Systems | 2026 | 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 34 years and passes through 3 companies; a new generation was cleared every 20.1 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K252930 (ZheJiang Decans Medical Devices Co., Ltd., 2026) has gone furthest, with 0 descendants of its own.
- 11 other devices also cite its predicate K050082.
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. 2019, 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 NuVasive® Camber Laminoplasty System is intended for use in the lower cervical and upper thoracic spine (C3 to T3) in laminoplasty procedures. The Camber Laminoplasty System is used to hold the allograft or autograft material in place in order to prevent the allograft or autograft material from expulsion, or impinging the spinal cord.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K191169 · printed Nov 6, 2026
Cite this page
510(k) Report. “K191169: NuVasive® Camber Laminoplasty System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K191169
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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