510(k) Report

510(k) · Cleared

Cleared

NuVasive ALIF Buttress Plate System

K143065510(k) TraditionalCleared Jan 21, 201589-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

Nu Vasive, Incorporated · KWQ Appliance, Fixation, Spinal Intervertebral Body

Cleared on Jan 21, 2015 as substantially equivalent to K021039 (Depuyacromed, 2002) and 5 other predicates after an 89-day review. Its family tree reaches back 5 generations to 1993. 1 later device descends from it.

Decided
Jan 21, 2015
Review
89 days
Class
Class II
Product code
KWQ
Recalls
None
Predicates
6

Its longest line of descent runs back 5 generations to K922543 (1993). 18 ancestors in all. 1 later device descends from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2009: 1 other ancestor2008: 1 other ancestor2007: 1 other ancestor2004: 1 other ancestor2002: 1 other ancestor2001: 2 other ancestors1997: 2 other ancestors1995: 1 other ancestor1993: 2 other ancestors2000: 1 other ancestor2026: 1 descendant 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. · 2011K121837 · Nuvasive Brigade Anterior Plate System · Nuvasive, Inc. · 20121990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 5 other ancestors2 generations back: 2 other ancestors3 generations back: 3 other ancestors4 generations back: 1 other ancestor5 generations back: 2 other ancestors 1 generation forward: 1 descendant K121837 · Nuvasive Brigade Anterior Plate System · Nuvasive, Inc. · 2012K111866 · 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. · 1993−50
  1. Root · 5 generations backK922543 Z-Plate Anterior Fixation SystemSofamor Danek Mfg., Inc. · 1993
  2. 4 generations backK013665 Pyramid Anterior Plate Fixation SystemMedtronic Sofamor Danek, Inc. · 2002
  3. 3 generations backK052546 Aegis Anterior Lumbar Plate SystemDepuy Spine, Inc. · 2006
  4. 2 generations backK111866 Nuvasive Anterior Lumbar Plate SystemNuvasive, Inc. · 2011
  5. 1 generation backK121837 Nuvasive Brigade Anterior Plate SystemNuvasive, Inc. · 2012
  6. This deviceK143065 NuVasive ALIF Buttress Plate SystemNu Vasive, Incorporated · 2015
  7. Descendant · cites it directly · 0 of its ownK261309 Palisades™ Buttress Plate SystemBethesda Medical Devices, LLC · 2026

Most influential descendants

Showing 1 of 1 · See all
  • K261309Palisades™ Buttress Plate SystemBethesda Medical Devices, LLC · 2026 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−5K922543Z-Plate Anterior Fixation SystemSofamor Danek Mfg., Inc.1993—
−4K013665Pyramid Anterior Plate Fixation SystemMedtronic Sofamor Danek, Inc.2002—
−3K052546Aegis Anterior Lumbar Plate SystemDepuy Spine, Inc.2006—
−2K111866Nuvasive Anterior Lumbar Plate SystemNuvasive, Inc.2011—
−1K121837Nuvasive Brigade Anterior Plate SystemNuvasive, Inc.2012—
0 (this device)K143065NuVasive ALIF Buttress Plate SystemNu Vasive, Incorporated2015—
+1K261309Palisades™ Buttress Plate SystemBethesda Medical Devices, LLC2026—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199320
199510
199720
200010
200120
200210
200410
200710
200810
200910

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202610
FIG. 1 — Lineage of K143065, 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? (6)

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
*K021039Bowti Anterior Buttress Staple System
Summary page 4
…Predicate Devices The subject ALIF Buttress Plate System is substantially equivalent to the following predicate devices: Primary Predicates • K021039, Depuy AcroMed BowTi Anterior Buttress Staple System Additional Predicates • K121837, NuVasive Brigade® Anterior…
Depuyacromed2002—
*K121837Nuvasive Brigade Anterior Plate System
Summary page 4
…llowing predicate devices: Primary Predicates • K021039, Depuy AcroMed BowTi Anterior Buttress Staple System Additional Predicates • K121837, NuVasive Brigade® Anterior Plate System • K072339, NuVasive Anterior Lumbar Plate System • K072943, X-spin…
Nuvasive, Inc.2012—
*K072339Nuvasive Anterior Lumbar Plate System
Summary page 4
…• K021039, Depuy AcroMed BowTi Anterior Buttress Staple System Additional Predicates • K121837, NuVasive Brigade® Anterior Plate System • K072339, NuVasive Anterior Lumbar Plate System • K072943, X-spine Systems Butrex™ Buttress Plating System • K040130…
Nuvasive, Inc.2007—
*K072943Butrex Buttress Plating System
Summary page 4
…System Additional Predicates • K121837, NuVasive Brigade® Anterior Plate System • K072339, NuVasive Anterior Lumbar Plate System • K072943, X-spine Systems Butrex™ Buttress Plating System • K040130, SeaSpine Anterior Lumbar Buttress System • K090…
X-Spine Systems, Inc.2008—
*K040130Anterior Lumbar Buttress System
Summary page 4
…ade® Anterior Plate System • K072339, NuVasive Anterior Lumbar Plate System • K072943, X-spine Systems Butrex™ Buttress Plating System • K040130, SeaSpine Anterior Lumbar Buttress System • K090415, Eminent Spine Fang Plate System D. Device Description The…
Seaspine2004—
*K090415Eminent Spine Buttress (Fang) Plate System
Summary page 4
…ior Lumbar Plate System • K072943, X-spine Systems Butrex™ Buttress Plating System • K040130, SeaSpine Anterior Lumbar Buttress System • K090415, Eminent Spine Fang Plate System D. Device Description The NuVasive ALIF Buttress Plate System is an anterior non-load be…
Eminent Spine20091

Also cleared against K021039: 7 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
K261309Palisades™ Buttress Plate SystemBethesda Medical Devices, LLC20260

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 22 years and passes through 5 companies; a new generation was cleared every 4.0 years on median.
  • 1 of the 18 ancestors has a recall of any class.
  • Of its descendants, K261309 (Bethesda Medical Devices, LLC, 2026) has gone furthest, with 0 descendants of its own.
  • 7 other devices also cite its predicate K021039.

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. 2015, 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 ALIF Buttress Plate System is an anterior non-load bearing plate system that may be used in the thoracic, lumbar and sacral spine (T1-S1). The NuVasive ALIF Buttress Plate System, in conjuction with traditional rigid fixation, is intended for use in spinal fusion procedures as a means to maintain the relative position of weak bony tissue such as allografts and autografts. This device is not intended for load bearing applications.

Indications for use as stated in the FDA summary.

Also cleared against K021039

7 other devices cite the same predicate.

  • K192281AEGIS Anterior Lumbar Plate System, ALC Dynamized Fixation System, Anterior ISOLA Spine System, BOWTI…Medos International SARL · 2019
  • K133911Genesys Spine Anterior Buttress Plate SystemGenesys Spine · 2014
  • K073349Reliance Buttress Washer SystemReliance Medical Systems, LLC · 2008
  • K061385Osstaple, Ossplate, OssforceBiomedical Enterprises, Inc. · 2007
  • K062181C-Jaws Cervical Compressive Mini FrameMedicrea Technologies · 2007
  • K041105Macropore Hydrosorb Spine SystemMacropore Biosurgery, Inc. · 2004

More from Nu Vasive, Incorporated

112 FDA decisions under this applicant name. See the company

  • K231735NuVasive CoRoent Small Interbody System; NuVasive CoRoent Small Contoured Interbody System; NuVasive CoRoent…Nu Vasive, Incorporated · 2023
  • K230894NuVasive Modulus ALIF SystemNu Vasive, Incorporated · 2023
  • K230989Rod Registration FrameNu Vasive, Incorporated · 2023
  • K223181NuVasive Reline SystemNu Vasive, Incorporated · 2023
  • K221751NuVasive Cohere ALIF System Intervertebral Body Fusion DeviceNu Vasive, Incorporated · 2022

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/K143065 · printed Nov 6, 2026

Cite this page

510(k) Report. “K143065: NuVasive ALIF Buttress 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/K143065

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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