510(k) Report

510(k) · Cleared

Cleared

Nuvasive Long Lateral Spinal System

K111410510(k) SpecialCleared Jun 20, 201132-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 Jun 20, 2011 as substantially equivalent to K091502 (Nuvasive, Inc., 2009) and 3 other predicates after a 32-day review. Its family tree reaches back 3 generations to 1993. 1 later device descends from it.

Decided
Jun 20, 2011
Review
32 days
Class
Class II
Product code
KWQ
Recalls
None
Predicates
4

Its longest line of descent runs back 3 generations to K922543 (1993). 8 ancestors in all. 1 later device descends from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2009: 1 other ancestor1999: 1 other ancestor1997: 1 other ancestor2006: 1 other ancestor2000: 1 other ancestor2013: 1 descendant clearedK922543 · Z-Plate Anterior Fixation System · Sofamor Danek Mfg., Inc. · 1993K990959 · K-Centrum Anterior Spinal Fixation System · Spineology, Inc. · 1999K011556 · Macs Hma Anterior Spinal Stabilization System · Aesculap, Inc. · 20011990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 3 other ancestors2 generations back: 2 other ancestors 1 generation forward: 1 descendant K011556 · Macs Hma Anterior Spinal Stabilization System · Aesculap, Inc. · 2001K990959 · K-Centrum Anterior Spinal Fixation System · Spineology, Inc. · 1999K922543 · Z-Plate Anterior Fixation System · Sofamor Danek Mfg., Inc. · 19930
  1. Root · 3 generations backK922543 Z-Plate Anterior Fixation SystemSofamor Danek Mfg., Inc. · 1993
  2. 2 generations backK990959 K-Centrum Anterior Spinal Fixation SystemSpineology, Inc. · 1999
  3. 1 generation backK011556 Macs Hma Anterior Spinal Stabilization SystemAesculap, Inc. · 2001
  4. This deviceK111410 Nuvasive Long Lateral Spinal SystemNuvasive, Inc. · 2011
  5. Descendant · cites it directly · 0 of its ownK122081 Nuvasive Long Lateral Spinal SystemNuvasive, Inc. · 2013

Most influential descendants

Showing 1 of 1 · See all
  • K122081Nuvasive Long Lateral Spinal SystemNuvasive, Inc. · 2013 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K922543Z-Plate Anterior Fixation SystemSofamor Danek Mfg., Inc.1993—
−2K990959K-Centrum Anterior Spinal Fixation SystemSpineology, Inc.1999—
−1K011556Macs Hma Anterior Spinal Stabilization SystemAesculap, Inc.2001—
0 (this device)K111410Nuvasive Long Lateral Spinal SystemNuvasive, Inc.2011—
+1K122081Nuvasive Long Lateral Spinal SystemNuvasive, Inc.2013—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199710
199910
200010
200610
200910

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201310
FIG. 1 — Lineage of K111410, 1993–2013Source: 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
*K091502Nuvasive Spherx II System
Summary page 1
…Product Code: KWQ C. Predicate Devices The subject Long Lateral Spinal System is substantially equivalent to the following devices: " K09 1502 - NuVasive, Inc. SpheRx Spinal System " K01 1556 - Aesculap MACS TL HMA Anterior Spinal Stabilization System * K965 145…
Nuvasive, Inc.2009—
*K011556Macs Hma Anterior Spinal Stabilization System
Summary page 1
…vices The subject Long Lateral Spinal System is substantially equivalent to the following devices: " K09 1502 - NuVasive, Inc. SpheRx Spinal System " K01 1556 - Aesculap MACS TL HMA Anterior Spinal Stabilization System * K965 145 - DePuy, Inc. Moss Miami Ti " K993030 - DePuy, I…
Aesculap, Inc.2001—
*K965145Depuy Motech Moss Miami Spinal System
Summary page 1
…t to the following devices: " K09 1502 - NuVasive, Inc. SpheRx Spinal System " K01 1556 - Aesculap MACS TL HMA Anterior Spinal Stabilization System * K965 145 - DePuy, Inc. Moss Miami Ti " K993030 - DePuy, Inc. ISOLA D. Device Description The NuVasive Long Lateral Spinal Sys…
Depuy, Inc.1997—
*K993030Modification to Isola Spinal System
Summary page 1
…1502 - NuVasive, Inc. SpheRx Spinal System " K01 1556 - Aesculap MACS TL HMA Anterior Spinal Stabilization System * K965 145 - DePuy, Inc. Moss Miami Ti " K993030 - DePuy, Inc. ISOLA D. Device Description The NuVasive Long Lateral Spinal System consists of a variety of screws, rods,…
Depuyacromed1999—

Also cleared against K091502: 4 other devices →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K122081Nuvasive Long Lateral Spinal SystemNuvasive, Inc.20130

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 6.6 years on median.
  • None of the 8 ancestors has a recall.
  • Of its descendants, K122081 (Nuvasive, Inc., 2013) has gone furthest, with 0 descendants of its own.
  • 4 other devices also cite its predicate K091502.

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. 2011, 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?

When used as an anterolateral non-pedicle screw system in the thoracic and lumbar spine, the NuVasive Long Lateral Spinal System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the spine: (1) degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), (2) spinal stenosis, (3) spondylolisthesis, (4) spinal deformities, (5) fracture, (6) pseudloarthosis, (7) tumor resection, and/or (8) failed previous fusion.

Indications for use as stated in the FDA summary.

Also cleared against K091502

4 other devices cite the same predicate.

  • K143684NuVasive Reline SystemNu Vasive, Incorporated · 2015
  • K132014GSB Global Spinal Balance SystemNuvasive, Inc. · 2013
  • K102514Nuvasive Spherx II -Mas Deformity Spinal SystemNuvasive, Inc. · 2010
  • K092287Nuvasive Spherx II - Pedicle Screw SystemNuvasive, Inc. · 2009

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/K111410 · printed Nov 4, 2026

Cite this page

510(k) Report. “K111410: Nuvasive Long Lateral Spinal System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K111410

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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