510(k) · Cleared
ClearedNuvasive Anterior Lumbar 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 22, 2011 as substantially equivalent to K072339 (Nuvasive, Inc., 2007) and 1 other predicate after a 22-day review. Its family tree reaches back 3 generations to 1993. 35 later devices descend from it.
- Decided
- Jul 22, 2011
- Review
- 22 days
- Class
- Class II
- Product code
- KWQ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K922543 (1993). 7 ancestors in all. 35 later devices descend from it, 3 citing it directly.
- Root · 3 generations backK922543 Z-Plate Anterior Fixation SystemSofamor Danek Mfg., Inc. · 1993
- 2 generations backK013665 Pyramid Anterior Plate Fixation SystemMedtronic Sofamor Danek, Inc. · 2002
- 1 generation backK052546 Aegis Anterior Lumbar Plate SystemDepuy Spine, Inc. · 2006
- This deviceK111866 Nuvasive Anterior Lumbar Plate SystemNuvasive, Inc. · 2011
- Descendant · cites it directly · 19 of its ownK130868 Nuvasive Decade Lateral Plate SystemNuvasive, Inc. · 2013
- Descendant · cites it directly · 15 of its ownK190016 Lateral Plate SystemCorelink, LLC · 2019
- Descendant · 2 generations on · 14 of its ownK192006 SIRION Lateral Lumbar Interbody SystemAstura Medical, LLC · 2020
- Descendant · 2 generations on · 9 of its ownK203065 Lumbar Spine Truss System Plating Solution (LSTS-PS)4Web, Inc. · 2021
- Descendant · 3 generations on · 6 of its ownK202495 SIRION Lateral Lumbar Interbody FusionAstura Medical, LLC · 2021
Showing 5 of 35 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 35 · See all- K130868Nuvasive Decade Lateral Plate SystemNuvasive, Inc. · 2013 · cites it directly19descendants
- K190016Lateral Plate SystemCorelink, LLC · 2019 · cites it directly15descendants
- K192006SIRION Lateral Lumbar Interbody SystemAstura Medical, LLC · 2020 · 2 generations on14descendants
- K203065Lumbar Spine Truss System Plating Solution (LSTS-PS)4Web, Inc. · 2021 · 2 generations on9descendants
- K202495SIRION Lateral Lumbar Interbody FusionAstura Medical, LLC · 2021 · 3 generations on6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K922543 | Z-Plate Anterior Fixation System | Sofamor Danek Mfg., Inc. | 1993 | — |
| −2 | K013665 | Pyramid Anterior Plate Fixation System | Medtronic Sofamor Danek, Inc. | 2002 | — |
| −1 | K052546 | Aegis Anterior Lumbar Plate System | Depuy Spine, Inc. | 2006 | — |
| 0 (this device) | K111866 | Nuvasive Anterior Lumbar Plate System | Nuvasive, Inc. | 2011 | — |
| +1 | K130868 | Nuvasive Decade Lateral Plate System | Nuvasive, Inc. | 2013 | — |
| +1 | K190016 | Lateral Plate System | Corelink, LLC | 2019 | — |
| +2 | K192006 | SIRION Lateral Lumbar Interbody System | Astura Medical, LLC | 2020 | — |
| +2 | K203065 | Lumbar Spine Truss System Plating Solution (LSTS-PS) | 4Web, Inc. | 2021 | — |
| +3 | K202495 | SIRION Lateral Lumbar Interbody Fusion | Astura Medical, LLC | 2021 | — |
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 |
|---|---|---|
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 3 | 0 |
| 2021 | 2 | 0 |
| 2022 | 3 | 0 |
| 2023 | 6 | 0 |
| 2024 | 7 | 0 |
| 2025 | 5 | 0 |
| 2026 | 5 | 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 |
|---|---|---|---|
| * | K072339 | Nuvasive Anterior Lumbar Plate SystemSummary page 1…KWQ C. Predicate Devices The subject NuVasive Halo HI Anterior Lumbar Plate System is substantially equivalent to the following devices: * K072339 - NuVasive, Inc. Anterior Lumbar Plate System " K052546 - Depuy Spine AEGIS Anterior Lumbar Plate System D. Device Descri… | 2007 |
| * | K052546 | Aegis Anterior Lumbar Plate SystemSummary page 1…asive Halo HI Anterior Lumbar Plate System is substantially equivalent to the following devices: * K072339 - NuVasive, Inc. Anterior Lumbar Plate System " K052546 - Depuy Spine AEGIS Anterior Lumbar Plate System D. Device Description The NuVasive Halo HI Anterior Lumbar Plate System… | 2006 |
What descends from it? (35)
See all 353 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 18 years and passes through 4 companies; a new generation was cleared every 5.5 years on median.
- None of the 7 ancestors has a recall.
- Of its descendants, K130868 (Nuvasive, Inc., 2013) has gone furthest, with 19 descendants of its own.
- 4 other devices also cite its predicate K072339.
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. 2011, 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 Halo 11Anterior Lumbar 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 (TI1-5) spine instability or via the anterior surgical approach, below the bifurcation of the great vessels in the treatment of lumbar and lumbosacral (Li-Si) 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/K111866 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111866: Nuvasive Anterior Lumbar 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/K111866
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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