510(k) Report

510(k) · Cleared

Cleared

Ebi Vuelock Anterior Cervical Plate System

K010003510(k) SpecialCleared Jan 31, 200129-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

Ebi, L.P. · KWQ Appliance, Fixation, Spinal Intervertebral Body

Cleared on Jan 31, 2001 after a 29-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 130 later devices descend from it.

Decided
Jan 31, 2001
Review
29 days
Class
Class II
Product code
KWQ
Recalls
None
Predicates
0

130 later devices descend from it, 5 citing it directly.

Descendants, by year cleared 2013: 2 descendants cleared2007: 2 descendants cleared2004: 1 descendant cleared2005: 2 descendants cleared2012: 1 descendant cleared2008: 3 descendants cleared2006: 1 descendant cleared2016: 3 descendants cleared2022: 10 descendants cleared2021: 6 descendants cleared2009: 1 descendant cleared2017: 3 descendants cleared2019: 6 descendants cleared2018: 5 descendants cleared2014: 1 descendant cleared2023: 16 descendants cleared2025: 26 descendants cleared2024: 19 descendants cleared2020: 4 descendants cleared2026: 18 descendants cleared200020052010201520202025
  1. This deviceK010003 Ebi Vuelock Anterior Cervical Plate SystemEbi, L.P. · 2001
  2. Descendant · cites it directly · 97 of its ownK131025 Archon Anterior Cervical Plate SystemNuvasive, Inc. · 2013
  3. Descendant · 2 generations on · 94 of its ownK161442 NuVasive® CoRoent® Small Interlock™ SystemNu Vasive, Incorporated · 2016
  4. Descendant · 3 generations on · 83 of its ownK173115 COALITION® and COALITION® TPS, COALITION MIS® and COALITION MIS®…Globus Medical, Inc. · 2017
  5. Descendant · 4 generations on · 37 of its ownK180909 REVEL SpacersGlobus Medical, Inc. · 2018
  6. Descendant · 4 generations on · 36 of its ownK191243 HEDRON Cervical SpacersGlobus Medical, Inc. · 2019

Showing 5 of 130 descendants. See all descendants

Descendants cleared per year

2004: 12005: 22006: 12007: 22008: 32009: 12012: 12013: 22014: 12016: 32017: 32018: 52019: 62020: 42021: 62022: 102023: 162024: 192025: 262026: 18
2004high 26 (2025) · low 0 (2010)2026

Most influential descendants

Showing 5 of 130 · See all
  • K131025Archon Anterior Cervical Plate SystemNuvasive, Inc. · 2013 · cites it directly97descendants
  • K161442NuVasive® CoRoent® Small Interlock™ SystemNu Vasive, Incorporated · 2016 · 2 generations on94descendants
  • K173115COALITION® and COALITION® TPS, COALITION MIS® and COALITION MIS® TPS, COALITION AGX® and…Globus Medical, Inc. · 2017 · 3 generations on83descendants
  • K180909REVEL SpacersGlobus Medical, Inc. · 2018 · 4 generations on37descendants
  • K191243HEDRON Cervical SpacersGlobus Medical, Inc. · 2019 · 4 generations on36descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K010003Ebi Vuelock Anterior Cervical Plate SystemEbi, L.P.2001—
+1K131025Archon Anterior Cervical Plate SystemNuvasive, Inc.2013—
+2K161442NuVasive® CoRoent® Small Interlock™ SystemNu Vasive, Incorporated2016—
+3K173115COALITION® and COALITION® TPS, COALITION MIS® and COALITION MIS® TPS…Globus Medical, Inc.2017—
+4K180909REVEL SpacersGlobus Medical, Inc.2018—
+4K191243HEDRON Cervical SpacersGlobus Medical, Inc.2019—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200410
200520
200610
200720
200830
200910
201210
201320
201410
201630
201730
201850
201960
202040
202160
2022100
2023160
2024190
2025260
2026180
FIG. 1 — Lineage of K010003, 2001–2026Source: 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), 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
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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (130)

See all 130

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

NumberDeviceApplicantDecidedDescendants
K131025Archon Anterior Cervical Plate SystemNuvasive, Inc.201397
K050588Verteview Anterior Cervical Plate SystemInnovative Spinal Design, LLC200516
K051815Modification to Vertebron SCP Cervical Plate SystemVertebron, Inc.200510
K071990Valeo Cervical Plate SystemAmedica Corp.20071
K033951Radix Cervical PlatePisharodi Surgicals, Inc.20041

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?

  • Of its descendants, K131025 (Nuvasive, Inc., 2013) has gone furthest, with 97 descendants of its own.

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—

More from Ebi, L.P.

101 FDA decisions under this applicant name. See the company

  • K100438Polaris Spinal System, Polaris/Synergy Structure Anterior Fixation SystemEbi, L.P. · 2010
  • K100220Polaris Spinal SystemEbi, L.P. · 2010
  • K093880Peanut Growth Control Plating SystemEbi, L.P. · 20101 recall
  • K092574Esl Spinal SystemEbi, L.P. · 2010
  • K093057Biomet Vision Footring SystemEbi, L.P. · 2009

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/K010003 · printed Nov 5, 2026

Cite this page

510(k) Report. “K010003: Ebi Vuelock Anterior Cervical Plate System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K010003

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026