510(k) Report

510(k) · Cleared

Cleared

Nuvasive Decade Lateral Plate System

K130868510(k) TraditionalCleared Aug 29, 2013153-day reviewClass II21 CFR 888.3060

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Nuvasive, Inc. · KWQ Appliance, Fixation, Spinal Intervertebral Body

Cleared on Aug 29, 2013 as substantially equivalent to K121815 (Nuvasive, Inc., 2012) and 1 other predicate after a 153-day review. Its family tree reaches back 4 generations to 1993. 19 later devices descend from it.

Decided
Aug 29, 2013
Review
153 days
Class
Class II
Product code
KWQ
Recalls
None
Predicates
2

Its longest line of descent runs back 4 generations to K922543 (1993). 15 ancestors in all. 19 later devices descend from it, 3 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2012: 1 other ancestor2008: 1 other ancestor2007: 1 other ancestor2006: 2 other ancestors2004: 1 other ancestor2002: 1 other ancestor2000: 2 other ancestors1997: 1 other ancestor2001: 1 other ancestor2022: 2 descendants cleared2020: 2 descendants cleared2023: 4 descendants cleared2021: 1 descendant cleared2024: 5 descendants cleared2026: 3 descendants cleared2025: 2 descendants clearedK922543 · Z-Plate Anterior Fixation System · Sofamor Danek Mfg., Inc. · 1993K013665 · Pyramid Anterior Plate Fixation System · Medtronic Sofamor Danek, Inc. · 2002K052546 · Aegis Anterior Lumbar Plate System · Depuy Spine, Inc. · 2006K111866 · Nuvasive Anterior Lumbar Plate System · Nuvasive, Inc. · 20111990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor2 generations back: 3 other ancestors3 generations back: 5 other ancestors4 generations back: 2 other ancestors 1 generation forward: 3 descendants2 generations forward: 6 descendants3 generations forward: 8 descendants4 generations forward: 2 descendants K111866 · Nuvasive Anterior Lumbar Plate System · Nuvasive, Inc. · 2011K052546 · Aegis Anterior Lumbar Plate System · Depuy Spine, Inc. · 2006K013665 · Pyramid Anterior Plate Fixation System · Medtronic Sofamor Danek, Inc. · 2002K922543 · Z-Plate Anterior Fixation System · Sofamor Danek Mfg., Inc. · 19930
  1. Root · 4 generations backK922543 Z-Plate Anterior Fixation SystemSofamor Danek Mfg., Inc. · 1993
  2. 3 generations backK013665 Pyramid Anterior Plate Fixation SystemMedtronic Sofamor Danek, Inc. · 2002
  3. 2 generations backK052546 Aegis Anterior Lumbar Plate SystemDepuy Spine, Inc. · 2006
  4. 1 generation backK111866 Nuvasive Anterior Lumbar Plate SystemNuvasive, Inc. · 2011
  5. This deviceK130868 Nuvasive Decade Lateral Plate SystemNuvasive, Inc. · 2013
  6. Descendant · cites it directly · 14 of its ownK192006 SIRION Lateral Lumbar Interbody SystemAstura Medical, LLC · 2020
  7. Descendant · 2 generations on · 6 of its ownK202495 SIRION Lateral Lumbar Interbody FusionAstura Medical, LLC · 2021
  8. Descendant · 2 generations on · 5 of its ownK222554 EL CAPITAN Anterior Lumbar Interbody FusionAstura Medical · 2023
  9. Descendant · 2 generations on · 3 of its ownK231743 F3D Lateral Lumbar Interbody System, CL5 Lateral Lumbar Interbody…Corelink, LLC · 2023
  10. Descendant · 3 generations on · 2 of its ownK240126 ProAM ALIF SystemPro Surgical, Inc. · 2024

Showing 5 of 19 descendants. See all descendants

Descendants cleared per year

2020: 22021: 12022: 22023: 42024: 52025: 22026: 3
2020high 5 (2024) · low 1 (2021)2026

Most influential descendants

Showing 5 of 19 · See all
  • K192006SIRION Lateral Lumbar Interbody SystemAstura Medical, LLC · 2020 · cites it directly14descendants
  • K202495SIRION Lateral Lumbar Interbody FusionAstura Medical, LLC · 2021 · 2 generations on6descendants
  • K222554EL CAPITAN Anterior Lumbar Interbody FusionAstura Medical · 2023 · 2 generations on5descendants
  • K231743F3D Lateral Lumbar Interbody System, CL5 Lateral Lumbar Interbody System, and Oro…Corelink, LLC · 2023 · 2 generations on3descendants
  • K240126ProAM ALIF SystemPro Surgical, Inc. · 2024 · 3 generations on2descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K922543Z-Plate Anterior Fixation SystemSofamor Danek Mfg., Inc.1993—
−3K013665Pyramid Anterior Plate Fixation SystemMedtronic Sofamor Danek, Inc.2002—
−2K052546Aegis Anterior Lumbar Plate SystemDepuy Spine, Inc.2006—
−1K111866Nuvasive Anterior Lumbar Plate SystemNuvasive, Inc.2011—
0 (this device)K130868Nuvasive Decade Lateral Plate SystemNuvasive, Inc.2013—
+1K192006SIRION Lateral Lumbar Interbody SystemAstura Medical, LLC2020—
+2K202495SIRION Lateral Lumbar Interbody FusionAstura Medical, LLC2021—
+2K222554EL CAPITAN Anterior Lumbar Interbody FusionAstura Medical2023—
+2K231743F3D Lateral Lumbar Interbody System, CL5 Lateral Lumbar Interbody System, and…Corelink, LLC2023—
+3K240126ProAM ALIF SystemPro Surgical, Inc.2024—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199710
200020
200110
200210
200410
200620
200710
200810
201210

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202020
202110
202220
202340
202450
202520
202630
FIG. 1 — Lineage of K130868, 1993–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K233640 Segmental Plating System (SPS);IdentiTi SPS…score 21.9 · 31 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K121815Nuvasive Sage Lateral Plate System
Summary page 1
…KWQ C. Predicate Devices The subject Decade Lateral Plate System is substantially equivalent to the predicate device, NuVasive®E Sage Lateral Plate System (K 121815) and NuVasive® Halo II Anterior Lumbar Plate System (KI 111866). D. Device Description The NuVasive Decade Lateral P…
Nuvasive, Inc.2012—
*K111866Nuvasive Anterior Lumbar Plate System
Summary page 1
…tem is substantially equivalent to the predicate device, NuVasive®E Sage Lateral Plate System (K 121815) and NuVasive® Halo II Anterior Lumbar Plate System (KI 111866). D. Device Description The NuVasive Decade Lateral Plate System is an anterior/anterolateral plate system that may…
Nuvasive, Inc.2011—

Also cleared against K121815: 1 other device →

What descends from it? (19)

See all 19

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K192006SIRION Lateral Lumbar Interbody SystemAstura Medical, LLC202014
K220478NuVasive MOD-EX XLIF Interbody System, NuVasive MOD-EX XLIF Plated 2.0 Interbody SystemNu Vasive, Incorporated20222
K200956NuVasive Thoracolumbar PlatesNu Vasive, Incorporated20200

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 20 years and passes through 4 companies; a new generation was cleared every 5.5 years on median.
  • None of the 15 ancestors has a recall.
  • Of its descendants, K192006 (Astura Medical, LLC, 2020) has gone furthest, with 14 descendants of its own.
  • 1 other device also cites its predicate K121815.

How does its category compare?

All KWQ devices

KWQ Appliance, Fixation, Spinal Intervertebral Body: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.

FDA decisions per year · KWQ

7in 2025

2007: 272008: 322009: 232010: 232011: 222012: 262013: 222014: 172015: 252016: 152017: 202018: 222019: 262020: 262021: 172022: 182023: 162024: 172025: 72026 (partial year): 10
2007high 32 (2008) · low 7 (2025)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KWQ

64in 2025

2007: 101 days median2008: 70 days median2009: 90 days median2010: 104 days median2011: 95 days median2012: 90 days median2013: 88 days median2014: 124 days median2015: 102 days median2016: 121 days median2017: 67 days median2018: 95 days median2019: 81 days median2020: 55 days median2021: 59 days median2022: 85 days median2023: 59 days median2024: 64 days median2025: 64 days median2026 (partial year): 76 days median
2007high 124 (2014) · low 55 (2020)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · KWQ

1in 2018

2007: 22008: 332009: 352010: 22011: 52012: 72013: 62015: 22016: 92017: 82018: 1
2007high 35 (2009) · low 0 (2014)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · KWQ

248in 2025

2007: 2882008: 3482009: 3552010: 6912011: 4152012: 5442013: 7962014: 5462015: 5622016: 5022017: 4922018: 3412019: 2982020: 4002021: 5912022: 3922023: 3202024: 4192025: 248
2007high 796 (2013) · low 248 (2025)2025

MAUDE reports naming product code KWQ, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007271012288
2008327033348
2009239035355
2010231042691
201122955415
201226907544
201322886796
2014171240546
2015251022562
2016151219502
201720678492
201822951341
201926810298
202026550400
202117590591
202218850392
202316590320
202417640419
20257640248
202610760—

What is it indicated for?

The NuVasive Decade Lateral 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-LS) 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.

Also cleared against K121815

1 other device cites the same predicate.

  • K131723Coroent Single Tab SystemNuvasive, Inc. · 2013

More from Nuvasive, Inc.

117 FDA decisions under this applicant name. See the company

  • P200022/S016Simplify® Cervical Artificial DiscNuvasive, Inc. · 2025
  • P200022/S017Simplify® Cervical Artificial DiscNuvasive, Inc. · 2025
  • P200022/S012Simplify DiscNuvasive, Inc. · 2025
  • P200022/S015Simplify Cervical Artificial DiscNuvasive, Inc. · 2025
  • P200022/S014Simplify Cervical Artificial DiscNuvasive, Inc. · 2024

Recent decisions in KWQ

The KWQ category page

  • K262149corra® cervical plating systemCarlsmed, Inc. · 2026
  • K261309Palisades™ Buttress Plate SystemBethesda Medical Devices, LLC · 2026
  • K252776ARIES Anterior Cervical Plate SystemsZheJiang Decans Medical Devices Co., Ltd. · 2026
  • K261112CastleLoc-P Anterior Cervical Plate SystemL&K BIOMED Co., Ltd. · 2026
  • K260570corra™ cervical plating systemCarlsmed, Inc. · 2026

https://510kreport.com/device/K130868 · printed Nov 6, 2026

Cite this page

510(k) Report. “K130868: Nuvasive Decade Lateral 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/K130868

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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