510(k) Report

510(k) · Cleared

Cleared

Vip Anterior Cervical Plate System

K081391510(k) SpecialCleared Jul 3, 200845-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 Jul 3, 2008 as substantially equivalent to K040721 (Globus Medical, Inc., 2004) and 1 other predicate after a 45-day review. Its family tree reaches back 3 generations to 1993. 171 later devices descend from it.

Decided
Jul 3, 2008
Review
45 days
Class
Class II
Product code
KWQ
Recalls
None
Predicates
2

Its longest line of descent runs back 3 generations to K926453 (1993). 6 ancestors in all. 171 later devices descend from it, 5 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2003: 2 other ancestors1997: 1 other ancestor2017: 5 descendants cleared2018: 3 descendants cleared2022: 20 descendants cleared2015: 1 descendant cleared2009: 1 descendant cleared2019: 6 descendants cleared2012: 1 descendant cleared2025: 34 descendants cleared2016: 1 descendant cleared2024: 33 descendants cleared2014: 1 descendant cleared2020: 8 descendants cleared2021: 13 descendants cleared2023: 23 descendants cleared2026: 21 descendants clearedK926453 · Synthes (U.S.a.) Anterior Cervical Vertebrae Plate · Synthes (Usa) · 1993K040721 · Assure Anterior Cervical Plate System · Globus Medical, Inc. · 2004K070775 · Modification to: Providence Anterior Cervical Plate System · Globus Medical, Inc. · 20071990200020102020
Other ancestors, by generationDescendants, by generation 2 generations back: 3 other ancestors 1 generation forward: 5 descendants2 generations forward: 14 descendants3 generations forward: 31 descendants4 generations forward: 28 descendants5 generations forward: 41 descendants6 generations forward: 34 descendants7 generations forward: 12 descendants8 generations forward: 5 descendants9 generations forward: 1 descendant K070775 · Modification to: Providence Anterior Cervical Plate System · Globus Medical, Inc. · 2007K040721 · Assure Anterior Cervical Plate System · Globus Medical, Inc. · 2004K926453 · Synthes (U.S.a.) Anterior Cervical Vertebrae Plate · Synthes (Usa) · 19930+5
  1. Root · 3 generations backK926453 Synthes (U.S.a.) Anterior Cervical Vertebrae PlateSynthes (Usa) · 1993
  2. 2 generations backK040721 Assure Anterior Cervical Plate SystemGlobus Medical, Inc. · 2004
  3. 1 generation backK070775 Modification to: Providence Anterior Cervical Plate SystemGlobus Medical, Inc. · 2007
  4. This deviceK081391 Vip Anterior Cervical Plate SystemGlobus Medical, Inc. · 2008
  5. Descendant · cites it directly · 155 of its ownK142218 Coalition AGX Plate and Coalition AGX SpacerGlobus Medical, Inc. · 2015
  6. Descendant · 2 generations on · 149 of its ownK152022 SUSTAIN® R Spacers, PATRIOT® Spacers, CALIBER® Spacers, RISE®…Globus Medical, Inc. · 2017
  7. Descendant · 3 generations on · 97 of its ownK181357 PATRIOT® Lumbar Spacers, SUSTAIN® SpacersGlobus Medical, Inc. · 2018
  8. Descendant · 4 generations on · 84 of its ownK191391 HEDRON Lumbar SpacersGlobus Medical, Inc. · 2019
  9. Descendant · 2 generations on · 83 of its ownK173115 COALITION® and COALITION® TPS, COALITION MIS® and COALITION MIS®…Globus Medical, Inc. · 2017

Showing 5 of 171 descendants. See all descendants

Descendants cleared per year

2009: 12012: 12014: 12015: 12016: 12017: 52018: 32019: 62020: 82021: 132022: 202023: 232024: 332025: 342026: 21
2009high 34 (2025) · low 0 (2010)2026

Most influential descendants

Showing 5 of 171 · See all
  • K142218Coalition AGX Plate and Coalition AGX SpacerGlobus Medical, Inc. · 2015 · cites it directly155descendants
  • K152022SUSTAIN® R Spacers, PATRIOT® Spacers, CALIBER® Spacers, RISE® Spacers, COALITION®…Globus Medical, Inc. · 2017 · 2 generations on149descendants
  • K181357PATRIOT® Lumbar Spacers, SUSTAIN® SpacersGlobus Medical, Inc. · 2018 · 3 generations on97descendants
  • K191391HEDRON Lumbar SpacersGlobus Medical, Inc. · 2019 · 4 generations on84descendants
  • K173115COALITION® and COALITION® TPS, COALITION MIS® and COALITION MIS® TPS, COALITION AGX® and…Globus Medical, Inc. · 2017 · 2 generations on83descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K926453Synthes (U.S.a.) Anterior Cervical Vertebrae PlateSynthes (Usa)1993—
−2K040721Assure Anterior Cervical Plate SystemGlobus Medical, Inc.2004—
−1K070775Modification to: Providence Anterior Cervical Plate SystemGlobus Medical, Inc.2007—
0 (this device)K081391Vip Anterior Cervical Plate SystemGlobus Medical, Inc.2008—
+1K142218Coalition AGX Plate and Coalition AGX SpacerGlobus Medical, Inc.2015—
+2K152022SUSTAIN® R Spacers, PATRIOT® Spacers, CALIBER® Spacers, RISE® Spacers…Globus Medical, Inc.2017—
+3K181357PATRIOT® Lumbar Spacers, SUSTAIN® SpacersGlobus Medical, Inc.2018—
+4K191391HEDRON Lumbar SpacersGlobus Medical, Inc.2019—
+2K173115COALITION® and COALITION® TPS, COALITION MIS® and COALITION MIS® TPS…Globus Medical, Inc.2017—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199710
200320

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200910
201210
201410
201510
201610
201750
201830
201960
202080
2021130
2022200
2023230
2024330
2025340
2026210
FIG. 1 — Lineage of K081391, 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
*K040721Assure Anterior Cervical Plate System
Summary page 1
…Product Code KWQ. Regulatory Class II and Ill, Panel Code 87. Predicate(s): Globus Medical ASSURE ®Anterior Cervical Plate System K040721, SE date June 14, 2004, and PROVIDENCE T M Anterior Cervical Plate System K070775, SE date April 19, 2007 Devic…
Globus Medical, Inc.2004—
*K070775Modification to: Providence Anterior Cervical Plate System
Summary page 1
…Globus Medical ASSURE ®Anterior Cervical Plate System K040721, SE date June 14, 2004, and PROVIDENCE T M Anterior Cervical Plate System K070775, SE date April 19, 2007 Device Description: The VIPTM Anterior Cervical Plate System consists of plates of vanous lengths to be…
Globus Medical, Inc.2007—

Also cleared against K040721: 6 other devices →

What descends from it? (171)

See all 171

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

NumberDeviceApplicantDecidedDescendants
K142218Coalition AGX Plate and Coalition AGX SpacerGlobus Medical, Inc.2015155
K092146Xtend Anterior Cervical Plate SystemGlobus Medical, Inc.200911
K181846ASSURE Anterior Cervical Plate System, PROVIDENCE Anterior Cervical Plate System, VIP…Globus Medical, Inc.20184
K173099Fortis and Hana Anterior Cervical Plate SystemHuvexel Co., Ltd.20174
K220334MONET Anterior Cervical Plate SystemCtl Medical Corporation20220

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 15 years and passes through 2 companies; a new generation was cleared every 2.8 years on median.
  • None of the 6 ancestors has a recall.
  • Of its descendants, K142218 (Globus Medical, Inc., 2015) has gone furthest, with 155 descendants of its own.
  • 6 other devices also cite its predicate K040721.

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. 2008, 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 VIPTM 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 K040721

6 other devices cite the same predicate.

  • K192314RESONATE Anterior Cervical Plate SystemGlobus Medical, Inc. · 2019
  • K181846ASSURE Anterior Cervical Plate System, PROVIDENCE Anterior Cervical Plate System, VIP Anterior Cervical…Globus Medical, Inc. · 2018
  • K133567Unify (R) Dynamic Anterior Cervical Plate SystemGlobus Medical, Inc. · 2014
  • K121049Unify Dynamic Anterior Cervical Plate SystemGlobus Medical, Inc. · 2012
  • K092146Xtend Anterior Cervical Plate SystemGlobus Medical, Inc. · 2009
  • K070775Modification to: Providence Anterior Cervical Plate SystemGlobus Medical, Inc. · 2007

More from Globus Medical, Inc.

184 FDA decisions under this applicant name. See the company

  • K262779ANTHEM™ Fracture SystemGlobus Medical, Inc. · 2026
  • K254043TRIVANCE™ Hip StemGlobus Medical, Inc. · 2026
  • K262251ACTIFY™ Total Knee System, ACTIFY™ 3D Total Knee System (ACTIFY MC Tibial Insert)Globus Medical, Inc. · 2026
  • 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/K081391 · printed Nov 4, 2026

Cite this page

510(k) Report. “K081391: Vip Anterior Cervical Plate System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K081391

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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