510(k) · Cleared
ClearedNuvasive Brigade Anterior Plate System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nuvasive, Inc. · KWQ Appliance, Fixation, Spinal Intervertebral Body
Cleared on Jul 16, 2012 as substantially equivalent to K111866 (Nuvasive, Inc., 2011) and 1 other predicate after a 24-day review. Its family tree reaches back 4 generations to 1993. 3 later devices descend from it.
- Decided
- Jul 16, 2012
- Review
- 24 days
- Class
- Class II
- Product code
- KWQ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K922543 (1993). 8 ancestors in all. 3 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK922543 Z-Plate Anterior Fixation SystemSofamor Danek Mfg., Inc. · 1993
- 3 generations backK013665 Pyramid Anterior Plate Fixation SystemMedtronic Sofamor Danek, Inc. · 2002
- 2 generations backK052546 Aegis Anterior Lumbar Plate SystemDepuy Spine, Inc. · 2006
- 1 generation backK111866 Nuvasive Anterior Lumbar Plate SystemNuvasive, Inc. · 2011
- This deviceK121837 Nuvasive Brigade Anterior Plate SystemNuvasive, Inc. · 2012
- Descendant · cites it directly · 1 of its ownK143065 NuVasive ALIF Buttress Plate SystemNu Vasive, Incorporated · 2015
- Descendant · 2 generations on · 0 of its ownK261309 Palisades™ Buttress Plate SystemBethesda Medical Devices, LLC · 2026
- Descendant · cites it directly · 0 of its ownK200956 NuVasive Thoracolumbar PlatesNu Vasive, Incorporated · 2020
Most influential descendants
Showing 3 of 3 · See all- K143065NuVasive ALIF Buttress Plate SystemNu Vasive, Incorporated · 2015 · cites it directly1descendant
- K261309Palisades™ Buttress Plate SystemBethesda Medical Devices, LLC · 2026 · 2 generations on0descendants
- K200956NuVasive Thoracolumbar PlatesNu Vasive, Incorporated · 2020 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K922543 | Z-Plate Anterior Fixation System | Sofamor Danek Mfg., Inc. | 1993 | — |
| −3 | K013665 | Pyramid Anterior Plate Fixation System | Medtronic Sofamor Danek, Inc. | 2002 | — |
| −2 | K052546 | Aegis Anterior Lumbar Plate System | Depuy Spine, Inc. | 2006 | — |
| −1 | K111866 | Nuvasive Anterior Lumbar Plate System | Nuvasive, Inc. | 2011 | — |
| 0 (this device) | K121837 | Nuvasive Brigade Anterior Plate System | Nuvasive, Inc. | 2012 | — |
| +1 | K143065 | NuVasive ALIF Buttress Plate System | Nu Vasive, Incorporated | 2015 | — |
| +2 | K261309 | Palisades™ Buttress Plate System | Bethesda Medical Devices, LLC | 2026 | — |
| +1 | K200956 | NuVasive Thoracolumbar Plates | Nu Vasive, Incorporated | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2020 | 1 | 0 |
| 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 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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K111866 | Nuvasive Anterior Lumbar Plate SystemSummary page 1…KWQ C. Predicate Devices The subject NuVasive Brigade Anterior Plate System is substantially equivalent to the following devices: * KI 111866 -NuVasive, Inc. Halo® If Anterior Lumbar Plate System * K072339 - NuVasive Anterior Lumbar Plate System D. Device Descr… | 2011 |
| * | K072339 | Nuvasive Anterior Lumbar Plate SystemSummary page 1…rigade Anterior Plate System is substantially equivalent to the following devices: * KI 111866 -NuVasive, Inc. Halo® If Anterior Lumbar Plate System * K072339 - NuVasive Anterior Lumbar Plate System D. Device Description The NuVasive Brigade Anterior Plate System is an anterior/a… | 2007 |
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 19 years and passes through 4 companies; a new generation was cleared every 5.5 years on median.
- None of the 8 ancestors has a recall.
- Of its descendants, K143065 (Nu Vasive, Incorporated, 2015) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K111866.
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. 2012, 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 NuVasive Brigade Anterior Plate System is indicated for use via a lateral or anterolateral surgical approach above the bifurcation of the great vessels in the treatment of thoracic and thoracolumbar (T1-L5) spine instability or via the anterior surgical approach, below the bifurcation of the great vessels in the treatment of lumbar and lumbosacral (L1-S1) spine instability as a result of fracture (including dislocation and subluxation), tumor, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), scoliosis, kyphosis, lordosis, spinal stenosis, or a failed previous spine surgery.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K121837 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121837: Nuvasive Brigade Anterior Plate System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121837
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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