510(k) Report

510(k) · Cleared

Cleared

Assure Anterior Cervical Plate System

K040721510(k) TraditionalCleared Jun 17, 200490-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

Globus Medical, Inc. · KWQ Appliance, Fixation, Spinal Intervertebral Body

Cleared on Jun 17, 2004 as substantially equivalent to K926453 (Synthes (Usa), 1993) and 3 other predicates after a 90-day review. Its family tree reaches back 1 generation to 1993. 178 later devices descend from it.

Decided
Jun 17, 2004
Review
90 days
Class
Class II
Product code
KWQ
Recalls
None
Predicates
4

Its longest line of descent runs back 1 generation to K926453 (1993). 4 ancestors in all. 178 later devices descend from it, 7 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2003: 2 other ancestors1997: 1 other ancestor2014: 1 descendant cleared2019: 7 descendants cleared2008: 1 descendant cleared2018: 3 descendants cleared2009: 1 descendant cleared2007: 1 descendant cleared2012: 1 descendant cleared2015: 2 descendants cleared2010: 1 descendant cleared2020: 9 descendants cleared2017: 5 descendants cleared2022: 20 descendants cleared2024: 34 descendants cleared2025: 34 descendants cleared2016: 1 descendant cleared2021: 13 descendants cleared2023: 23 descendants cleared2026: 21 descendants clearedK926453 · Synthes (U.S.a.) Anterior Cervical Vertebrae Plate · Synthes (Usa) · 19931990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 3 other ancestors 1 generation forward: 7 descendants2 generations forward: 10 descendants3 generations forward: 15 descendants4 generations forward: 27 descendants5 generations forward: 26 descendants6 generations forward: 41 descendants7 generations forward: 34 descendants8 generations forward: 12 descendants9 generations forward: 5 descendants10 generations forward: 1 descendant K926453 · Synthes (U.S.a.) Anterior Cervical Vertebrae Plate · Synthes (Usa) · 19930+5+10
  1. Root · 1 generation backK926453 Synthes (U.S.a.) Anterior Cervical Vertebrae PlateSynthes (Usa) · 1993
  2. This deviceK040721 Assure Anterior Cervical Plate SystemGlobus Medical, Inc. · 2004
  3. Descendant · cites it directly · 177 of its ownK070775 Modification to: Providence Anterior Cervical Plate SystemGlobus Medical, Inc. · 2007
  4. Descendant · cites it directly · 171 of its ownK081391 Vip Anterior Cervical Plate SystemGlobus Medical, Inc. · 2008
  5. Descendant · 2 generations on · 155 of its ownK142218 Coalition AGX Plate and Coalition AGX SpacerGlobus Medical, Inc. · 2015
  6. Descendant · 3 generations on · 149 of its ownK152022 SUSTAIN® R Spacers, PATRIOT® Spacers, CALIBER® Spacers, RISE®…Globus Medical, Inc. · 2017
  7. Descendant · 4 generations on · 97 of its ownK181357 PATRIOT® Lumbar Spacers, SUSTAIN® SpacersGlobus Medical, Inc. · 2018

Showing 5 of 178 descendants. See all descendants

Descendants cleared per year

2007: 12008: 12009: 12010: 12012: 12014: 12015: 22016: 12017: 52018: 32019: 72020: 92021: 132022: 202023: 232024: 342025: 342026: 21
2007high 34 (2024) · low 0 (2011)2026

Most influential descendants

Showing 5 of 178 · See all
  • K070775Modification to: Providence Anterior Cervical Plate SystemGlobus Medical, Inc. · 2007 · cites it directly177descendants
  • K081391Vip Anterior Cervical Plate SystemGlobus Medical, Inc. · 2008 · cites it directly171descendants
  • K142218Coalition AGX Plate and Coalition AGX SpacerGlobus Medical, Inc. · 2015 · 2 generations on155descendants
  • K152022SUSTAIN® R Spacers, PATRIOT® Spacers, CALIBER® Spacers, RISE® Spacers, COALITION®…Globus Medical, Inc. · 2017 · 3 generations on149descendants
  • K181357PATRIOT® Lumbar Spacers, SUSTAIN® SpacersGlobus Medical, Inc. · 2018 · 4 generations on97descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K926453Synthes (U.S.a.) Anterior Cervical Vertebrae PlateSynthes (Usa)1993—
0 (this device)K040721Assure Anterior Cervical Plate SystemGlobus Medical, Inc.2004—
+1K070775Modification to: Providence Anterior Cervical Plate SystemGlobus Medical, Inc.2007—
+1K081391Vip Anterior Cervical Plate SystemGlobus Medical, Inc.2008—
+2K142218Coalition AGX Plate and Coalition AGX SpacerGlobus Medical, Inc.2015—
+3K152022SUSTAIN® R Spacers, PATRIOT® Spacers, CALIBER® Spacers, RISE® Spacers…Globus Medical, Inc.2017—
+4K181357PATRIOT® Lumbar Spacers, SUSTAIN® SpacersGlobus Medical, Inc.2018—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199710
200320

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200710
200810
200910
201010
201210
201410
201520
201610
201750
201830
201970
202090
2021130
2022200
2023230
2024340
2025340
2026210
FIG. 1 — Lineage of K040721, 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? (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
*K926453Synthes (U.S.a.) Anterior Cervical Vertebrae Plate
Summary page 1
…tion is Class 11as per 21 CFR §888.3060 Spinal Intervertebral Body Fixation Orthosis. The product code is KWQ. The panel code is 87. PREDICATE DEVICES: Synthes CSLP: K926453, SE date October 12, 1993; K030866, April 18, 2003. Depuy PEAK: K971130, SE date November 3, 1997. Howmedica Osteonics (Stryker…
Synthes (Usa)1993—
*K030866Synthes Anterior CSLP System
Summary page 1
…3060 Spinal Intervertebral Body Fixation Orthosis. The product code is KWQ. The panel code is 87. PREDICATE DEVICES: Synthes CSLP: K926453, SE date October 12, 1993; K030866, April 18, 2003. Depuy PEAK: K971130, SE date November 3, 1997. Howmedica Osteonics (Stryker) Reflex: K031702, SE date August 8…
Synthes (Usa)2003—
*K971730Depuy Motech Peak Polyaxial Anterior Cervical Plate System
Our reading of the summary gave K971130, FDA’s number for Defend Fluid Resistant Pleated Mask (Carl Parker Associates, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Depuy PEAK”.
Depuy, Inc.1997—
*K031702Reflex Anterior Cervical Plate System
Summary page 1
…VICES: Synthes CSLP: K926453, SE date October 12, 1993; K030866, April 18, 2003. Depuy PEAK: K971130, SE date November 3, 1997. Howmedica Osteonics (Stryker) Reflex: K031702, SE date August 8, 2003. The product code for these devices is KWQ. DEVICE DESCRIPTION: The ASSURE Tm Anterior Cervical Plate…
Howmedica Osteonics2003—

Also cleared against K926453: 14 other devices →

What descends from it? (178)

See all 178

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

NumberDeviceApplicantDecidedDescendants
K070775Modification to: Providence Anterior Cervical Plate SystemGlobus Medical, Inc.2007177
K081391Vip Anterior Cervical Plate SystemGlobus Medical, Inc.2008171
K092146Xtend Anterior Cervical Plate SystemGlobus Medical, Inc.200911
K121049Unify Dynamic Anterior Cervical Plate SystemGlobus Medical, Inc.201210
K133567Unify (R) Dynamic Anterior Cervical Plate SystemGlobus Medical, Inc.20145
K181846ASSURE Anterior Cervical Plate System, PROVIDENCE Anterior Cervical Plate System, VIP…Globus Medical, Inc.20184
K192314RESONATE Anterior Cervical Plate SystemGlobus Medical, Inc.20193

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, K070775 (Globus Medical, Inc., 2007) has gone furthest, with 177 descendants of its own.
  • 14 other devices also cite its predicate K926453.

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.

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 ASSURETM Anterior Cervical Plate System is intended for anterior screw fixation to the cervical spine C2-C7 for the following indications: degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumors, deformity (defined as kyphosis, lordosis, or scoliosis), pseudarthrosis, failed previous fusion, spondylolisthesis, and spinal stenosis.

Indications for use as stated in the FDA summary.

Also cleared against K926453

14 other devices cite the same predicate.

  • K191786Cyclops™ Anterior Cervical Plate SystemDegen Medical, Inc. · 2019
  • K1824894CIS® Pinehurst Anterior Cervical Plate systemSolco Biomedical Co., Ltd. · 2019
  • K160604Cure™ Anterior Cervical Plate (ACP) SystemMeditech Spine, LLC · 2016
  • K153042TRYPTIK2C-plate Anterior Cervical Plate SystemSpineart · 20167 recalls
  • K113170Cervical PlateEisertech, LLC · 2012
  • K101848Sapphire Anterior Cervical Plate SystemSpinal Elements, Inc. · 2010

More from Globus Medical, Inc.

184 FDA decisions under this applicant name. See the company

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  • K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5 Stabilization System…Globus Medical, Inc. · 2026
  • K253401SCRIPT™ Implant SystemGlobus Medical, Inc. · 2026

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/K040721 · printed Nov 6, 2026

Cite this page

510(k) Report. “K040721: Assure Anterior Cervical 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/K040721

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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