510(k) Report

510(k) · Cleared

Cleared

Xtend Anterior Cervical Plate System

K092146510(k) TraditionalCleared Nov 16, 2009124-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 Nov 16, 2009 as substantially equivalent to K081391 (Globus Medical, Inc., 2008) and 2 other predicates after a 124-day review. Its family tree reaches back 4 generations to 1993. 11 later devices descend from it.

Decided
Nov 16, 2009
Review
124 days
Class
Class II
Product code
KWQ
Recalls
None
Predicates
3

Its longest line of descent runs back 4 generations to K926453 (1993). 7 ancestors in all. 11 later devices descend from it, 4 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2003: 2 other ancestors1997: 1 other ancestor2019: 2 descendants cleared2018: 1 descendant cleared2012: 1 descendant cleared2014: 1 descendant cleared2024: 3 descendants cleared2021: 1 descendant cleared2025: 2 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. · 2007K081391 · Vip Anterior Cervical Plate System · Globus Medical, Inc. · 20081990200020102020
Other ancestors, by generationDescendants, by generation 2 generations back: 3 other ancestors 1 generation forward: 4 descendants2 generations forward: 5 descendants3 generations forward: 2 descendants K081391 · Vip Anterior Cervical Plate System · Globus Medical, Inc. · 2008K070775 · 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
  1. Root · 4 generations backK926453 Synthes (U.S.a.) Anterior Cervical Vertebrae PlateSynthes (Usa) · 1993
  2. 3 generations backK040721 Assure Anterior Cervical Plate SystemGlobus Medical, Inc. · 2004
  3. 2 generations backK070775 Modification to: Providence Anterior Cervical Plate SystemGlobus Medical, Inc. · 2007
  4. 1 generation backK081391 Vip Anterior Cervical Plate SystemGlobus Medical, Inc. · 2008
  5. This deviceK092146 Xtend Anterior Cervical Plate SystemGlobus Medical, Inc. · 2009
  6. Descendant · cites it directly · 10 of its ownK121049 Unify Dynamic Anterior Cervical Plate SystemGlobus Medical, Inc. · 2012
  7. Descendant · 2 generations on · 5 of its ownK133567 Unify (R) Dynamic Anterior Cervical Plate SystemGlobus Medical, Inc. · 2014
  8. Descendant · cites it directly · 4 of its ownK181846 ASSURE Anterior Cervical Plate System, PROVIDENCE Anterior Cervical…Globus Medical, Inc. · 2018
  9. Descendant · cites it directly · 3 of its ownK192314 RESONATE Anterior Cervical Plate SystemGlobus Medical, Inc. · 2019
  10. Descendant · 2 generations on · 2 of its ownK231251 FlexWing Anterior Cervical Plate SystemJeil Medical Corporation · 2024

Showing 5 of 11 descendants. See all descendants

Descendants cleared per year

2012: 12014: 12018: 12019: 22021: 12024: 32025: 2
2012high 3 (2024) · low 0 (2013)2026

Most influential descendants

Showing 5 of 11 · See all
  • K121049Unify Dynamic Anterior Cervical Plate SystemGlobus Medical, Inc. · 2012 · cites it directly10descendants
  • K133567Unify (R) Dynamic Anterior Cervical Plate SystemGlobus Medical, Inc. · 2014 · 2 generations on5descendants
  • K181846ASSURE Anterior Cervical Plate System, PROVIDENCE Anterior Cervical Plate System, VIP…Globus Medical, Inc. · 2018 · cites it directly4descendants
  • K192314RESONATE Anterior Cervical Plate SystemGlobus Medical, Inc. · 2019 · cites it directly3descendants
  • K231251FlexWing Anterior Cervical Plate SystemJeil Medical Corporation · 2024 · 2 generations on2descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K926453Synthes (U.S.a.) Anterior Cervical Vertebrae PlateSynthes (Usa)1993—
−3K040721Assure Anterior Cervical Plate SystemGlobus Medical, Inc.2004—
−2K070775Modification to: Providence Anterior Cervical Plate SystemGlobus Medical, Inc.2007—
−1K081391Vip Anterior Cervical Plate SystemGlobus Medical, Inc.2008—
0 (this device)K092146Xtend Anterior Cervical Plate SystemGlobus Medical, Inc.2009—
+1K121049Unify Dynamic Anterior Cervical Plate SystemGlobus Medical, Inc.2012—
+2K133567Unify (R) Dynamic Anterior Cervical Plate SystemGlobus Medical, Inc.2014—
+1K181846ASSURE Anterior Cervical Plate System, PROVIDENCE Anterior Cervical Plate…Globus Medical, Inc.2018—
+1K192314RESONATE Anterior Cervical Plate SystemGlobus Medical, Inc.2019—
+2K231251FlexWing Anterior Cervical Plate SystemJeil Medical Corporation2024—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199710
200320

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201210
201410
201810
201920
202110
202430
202520
FIG. 1 — Lineage of K092146, 1993–2025Source: 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? (3)

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
*K081391Vip Anterior Cervical Plate System
Summary page 1
…§888.3060 Spinal Intervertebral Body Fixation Orthosis Product Code KWQ. Regulatory Class 11,Panel Code 87. Predicate(s): VIP® K081391 (SE date July 3, 2008) ASSURE® K040721 (SE date June 17, 2004) PROVIDENCE® K070775 (SE date Apr…
Globus Medical, Inc.2008—
*K040721Assure Anterior Cervical Plate System
Summary page 1
…hosis Product Code KWQ. Regulatory Class 11,Panel Code 87. Predicate(s): VIP® K081391 (SE date July 3, 2008) ASSURE® K040721 (SE date June 17, 2004) PROVIDENCE® K070775 (SE date April 19, 2007) Device Description: The XTENDTm Anterior C…
Globus Medical, Inc.2004—
*K070775Modification to: Providence Anterior Cervical Plate System
Summary page 1
…atory Class 11,Panel Code 87. Predicate(s): VIP® K081391 (SE date July 3, 2008) ASSURE® K040721 (SE date June 17, 2004) PROVIDENCE® K070775 (SE date April 19, 2007) Device Description: The XTENDTm Anterior Cervical Plate System consists of standard plates, Extender pl…
Globus Medical, Inc.2007—

Also cleared against K081391: 4 other devices →

What descends from it? (11)

See all 11

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

NumberDeviceApplicantDecidedDescendants
K121049Unify Dynamic Anterior Cervical Plate SystemGlobus Medical, Inc.201210
K181846ASSURE Anterior Cervical Plate System, PROVIDENCE Anterior Cervical Plate System, VIP…Globus Medical, Inc.20184
K192314RESONATE Anterior Cervical Plate SystemGlobus Medical, Inc.20193
K191584FORTICO Anterior Cervical Fixation SystemCamber Spine Technologies, LLC20192

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 16 years and passes through 2 companies; a new generation was cleared every 2.8 years on median.
  • None of the 7 ancestors has a recall.
  • Of its descendants, K121049 (Globus Medical, Inc., 2012) has gone furthest, with 10 descendants of its own.
  • 4 other devices also cite its predicate K081391.

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 XTENDTM 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 K081391

4 other devices cite the same predicate.

  • K220334MONET Anterior Cervical Plate SystemCtl Medical Corporation · 2022
  • K181846ASSURE Anterior Cervical Plate System, PROVIDENCE Anterior Cervical Plate System, VIP Anterior Cervical…Globus Medical, Inc. · 2018
  • K173099Fortis and Hana Anterior Cervical Plate SystemHuvexel Co., Ltd. · 2017
  • K142218Coalition AGX Plate and Coalition AGX SpacerGlobus Medical, Inc. · 2015

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/K092146 · printed Nov 6, 2026

Cite this page

510(k) Report. “K092146: Xtend 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/K092146

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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