510(k) Report

510(k) · Cleared

Cleared

Nuvasive Lateral Plate System

K091071510(k) SpecialCleared May 8, 200924-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 May 8, 2009 as substantially equivalent to K070273 (Nuvasive, Inc., 2007) and 3 other predicates after a 24-day review. Its family tree reaches back 1 generation to 2006. 74 later devices descend from it.

Decided
May 8, 2009
Review
24 days
Class
Class II
Product code
KWQ
Recalls
None
Predicates
4

Its longest line of descent runs back 1 generation to K061789 (2006). 4 ancestors in all. 74 later devices descend from it, 7 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2008: 1 other ancestor2007: 2 other ancestors2014: 3 descendants cleared2012: 1 descendant cleared2022: 9 descendants cleared2020: 6 descendants cleared2017: 2 descendants cleared2018: 3 descendants cleared2019: 5 descendants cleared2024: 10 descendants cleared2016: 3 descendants cleared2015: 1 descendant cleared2023: 13 descendants cleared2026: 8 descendants cleared2021: 5 descendants cleared2025: 5 descendants clearedK061789 · Lateral Plate System · Nuvasive, Inc. · 200620052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 3 other ancestors 1 generation forward: 7 descendants2 generations forward: 18 descendants3 generations forward: 25 descendants4 generations forward: 17 descendants5 generations forward: 6 descendants6 generations forward: 1 descendant K061789 · Lateral Plate System · Nuvasive, Inc. · 20060+5
  1. Root · 1 generation backK061789 Lateral Plate SystemNuvasive, Inc. · 2006
  2. This deviceK091071 Nuvasive Lateral Plate SystemNuvasive, Inc. · 2009
  3. Descendant · cites it directly · 46 of its ownK142699 LITe Plate SystemStryker Corporation · 2014
  4. Descendant · cites it directly · 41 of its ownK120092 Plymouth Thoracolumbar Plate SystemGlobus Medical, Inc. · 2012
  5. Descendant · 2 generations on · 24 of its ownK150449 LITe Plate SystemStryker Corp. · 2015
  6. Descendant · cites it directly · 17 of its ownK133194 Diamond Rattlesnake SystemEminent Spine · 2014
  7. Descendant · 2 generations on · 15 of its ownK190016 Lateral Plate SystemCorelink, LLC · 2019

Showing 5 of 74 descendants. See all descendants

Descendants cleared per year

2012: 12014: 32015: 12016: 32017: 22018: 32019: 52020: 62021: 52022: 92023: 132024: 102025: 52026: 8
2012high 13 (2023) · low 0 (2013)2026

Most influential descendants

Showing 5 of 74 · See all
  • K142699LITe Plate SystemStryker Corporation · 2014 · cites it directly46descendants
  • K120092Plymouth Thoracolumbar Plate SystemGlobus Medical, Inc. · 2012 · cites it directly41descendants
  • K150449LITe Plate SystemStryker Corp. · 2015 · 2 generations on24descendants
  • K133194Diamond Rattlesnake SystemEminent Spine · 2014 · cites it directly17descendants
  • K190016Lateral Plate SystemCorelink, LLC · 2019 · 2 generations on15descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K061789Lateral Plate SystemNuvasive, Inc.2006—
0 (this device)K091071Nuvasive Lateral Plate SystemNuvasive, Inc.2009—
+1K142699LITe Plate SystemStryker Corporation2014—
+1K120092Plymouth Thoracolumbar Plate SystemGlobus Medical, Inc.2012—
+2K150449LITe Plate SystemStryker Corp.2015—
+1K133194Diamond Rattlesnake SystemEminent Spine2014—
+2K190016Lateral Plate SystemCorelink, LLC2019—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200720
200810

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201210
201430
201510
201630
201720
201830
201950
202060
202150
202290
2023130
2024100
202550
202680
FIG. 1 — Lineage of K091071, 2006–2026Source: 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? (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.

TypeNumberDeviceApplicantDecidedRecalls
*K070273Modification to Nuvasive Lateral Plate System
Summary page 1
…System, Nu Vasive Lateral Plate System, and Ni. Vasive Anterior Lumbar Plate System 5 10(k) Number: K070273, K061789, K082070, and K072339 Date of Concurrence: April 3, 2008, August 10, 2006, September 24, 2008,…
Nuvasive, Inc.2007—
*K061789Lateral Plate System
Summary page 1
…System, Nu Vasive Lateral Plate System, and Ni. Vasive Anterior Lumbar Plate System 5 10(k) Number: K070273, K061789, K082070, and K072339 Date of Concurrence: April 3, 2008, August 10, 2006, September 24, 2008,…
Nuvasive, Inc.2006—
*K082070Nuvasive Lateral Plate System
Summary page 1
…em, Nu Vasive Lateral Plate System, and Ni. Vasive Anterior Lumbar Plate System 5 10(k) Number: K070273, K061789, K082070, and K072339 Date of Concurrence: April 3, 2008, August 10, 2006, September 24, 2008,…
Nuvasive, Inc.2008—
*K072339Nuvasive Anterior Lumbar Plate System
Summary page 1
…Lateral Plate System, and Ni. Vasive Anterior Lumbar Plate System 5 10(k) Number: K070273, K061789, K082070, and K072339 Date of Concurrence: April 3, 2008, August 10, 2006, September 24, 2008, and O…
Nuvasive, Inc.2007—

Also cleared against K070273: 2 other devices →

What descends from it? (74)

See all 74

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

NumberDeviceApplicantDecidedDescendants
K142699LITe Plate SystemStryker Corporation201446
K120092Plymouth Thoracolumbar Plate SystemGlobus Medical, Inc.201241
K133194Diamond Rattlesnake SystemEminent Spine201417
K140260Skyhawk Lateral Plate SystemOrthofix, Inc.201414
K1721312 Hole Lateral Plating SystemLife Spine, Inc.201710
K200846Balteum™ Lumbar Plate SystemHuvexel Co., Ltd.20204
K213820BALTEUM - ONE™ Lumbar Plate SystemHuvexel Co., Ltd.20223

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?

  • None of the 4 ancestors has a recall.
  • Of its descendants, K142699 (Stryker Corporation, 2014) has gone furthest, with 46 descendants of its own.
  • 2 other devices also cite its predicate K070273.

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. 2009, 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 Lateral Plate System is indicated for use as an adjunct to fusion via a lateral or anterolateral surgical approach above the bifurcation of the great vessels in the treatment of thoracic and thoracolumbar (TI-L5) 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…

Read the full statement (104 words)

The NuVasive Lateral Plate System is indicated for use as an adjunct to fusion via a lateral or anterolateral surgical approach above the bifurcation of the great vessels in the treatment of thoracic and thoracolumbar (TI-L5) 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 K070273

2 other devices cite the same predicate.

  • K120724Pioneer Lateral Plate SystemPioneer Surgical Technology, Inc. · 2012
  • K103750Nuvasive Traverse Plate SystemNuvasive, Inc. · 2011

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/K091071 · printed Nov 6, 2026

Cite this page

510(k) Report. “K091071: Nuvasive 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/K091071

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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