510(k) Report

510(k) · Cleared

Cleared

Ebi Anterior Cervical Plate System

K060379510(k) TraditionalCleared Mar 6, 200620-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 Mar 6, 2006 after a 20-day review. The FDA summary names its predicate without a number. 207 later devices descend from it.

Decided
Mar 6, 2006
Review
20 days
Class
Class II
Product code
KWQ
Recalls
None
Predicates
0

207 later devices descend from it, 4 citing it directly.

Descendants, by year cleared 2015: 9 descendants cleared2008: 2 descendants cleared2007: 1 descendant cleared2010: 1 descendant cleared2021: 12 descendants cleared2016: 8 descendants cleared2025: 29 descendants cleared2019: 12 descendants cleared2013: 4 descendants cleared2014: 6 descendants cleared2024: 27 descendants cleared2017: 5 descendants cleared2020: 18 descendants cleared2023: 26 descendants cleared2018: 3 descendants cleared2022: 17 descendants cleared2026: 27 descendants cleared20052010201520202025
  1. This deviceK060379 Ebi Anterior Cervical Plate SystemEbi, L.P. · 2006
  2. Descendant · cites it directly · 193 of its ownK080646 C-Tek Maxan Anterior Cervical Plate SystemBiomet Spine · 2008 · Recalled
  3. Descendant · 2 generations on · 132 of its ownK133475 Struxxure Anterior Cervical Plate and ScrewsNexxt Spine, LLC · 2013
  4. Descendant · 3 generations on · 106 of its ownK141376 Inertia Pedicle Screw System, Honour Spacer System, Facet Fixx…Nexxt Spine, LLC · 2014
  5. Descendant · 4 generations on · 100 of its ownK181435 ATEC Cervical Spacer SystemAlphatec Spine, Inc. · 2018
  6. Descendant · 5 generations on · 99 of its ownK183705 IdentiTi Porous Ti Interbody SystemAlphatec Spine, Inc. · 2019

Showing 5 of 207 descendants. See all descendants

Descendants cleared per year

2007: 12008: 22010: 12013: 42014: 62015: 92016: 82017: 52018: 32019: 122020: 182021: 122022: 172023: 262024: 272025: 292026: 27
2007high 29 (2025) · low 0 (2009)2026

Most influential descendants

Showing 5 of 207 · See all
  • K080646C-Tek Maxan Anterior Cervical Plate SystemBiomet Spine · 2008 · cites it directly193descendants
  • K133475Struxxure Anterior Cervical Plate and ScrewsNexxt Spine, LLC · 2013 · 2 generations on132descendants
  • K141376Inertia Pedicle Screw System, Honour Spacer System, Facet Fixx, Struxxure Anterior…Nexxt Spine, LLC · 2014 · 3 generations on106descendants
  • K181435ATEC Cervical Spacer SystemAlphatec Spine, Inc. · 2018 · 4 generations on100descendants
  • K183705IdentiTi Porous Ti Interbody SystemAlphatec Spine, Inc. · 2019 · 5 generations on99descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K060379Ebi Anterior Cervical Plate SystemEbi, L.P.2006—
+1K080646C-Tek Maxan Anterior Cervical Plate SystemBiomet Spine20082
+2K133475Struxxure Anterior Cervical Plate and ScrewsNexxt Spine, LLC2013—
+3K141376Inertia Pedicle Screw System, Honour Spacer System, Facet Fixx, Struxxure…Nexxt Spine, LLC2014—
+4K181435ATEC Cervical Spacer SystemAlphatec Spine, Inc.2018—
+5K183705IdentiTi Porous Ti Interbody SystemAlphatec Spine, Inc.2019—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200710
200820
201010
201340
201460
201590
201680
201750
201830
2019120
2020180
2021120
2022170
2023260
2024270
2025290
2026270
FIG. 1 — Lineage of K060379, 2006–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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
*—EBI VueLock Anterior Cervical Plate System
Named without a submission number
—
*—EBI SpineLink Anterior Cervical Plate System
Named without a submission number
—
*—Interpore Cross International C-Tek Anterior Cervical Plate System
Named without a submission number
—
*—Synthes Spine Anterior Cervical Vertebrae Plate System (Anterior CSLP)
Named without a submission number
—

What descends from it? (207)

See all 207

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

NumberDeviceApplicantDecidedDescendants
K080646C-Tek Maxan Anterior Cervical Plate SystemBiomet Spine2008193
K092474Pyrenees Cervical Plate System, Semi-Constrained ScrewsK2m, Inc.20108
K150983Pyrenees Cervical Plate SystemK2m20157
K071325Biomet Variable Locking Plate SystemBiomet Trauma20070

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, K080646 (Biomet Spine, 2008) has gone furthest, with 193 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—

What is it indicated for?

The EBI Anterior Cervical Plate System is intended for anterior interbody screw fixation of the cervical spine. The System is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusions in patients with degenerative disc disease (as defined by neck pain of discogenic origin confirmed by patient history and radiographic studies), trauma including fractures, tumors, deformity (defined as kyphosis, lordosis or scoliosis), pseudarthroses and/or failed previous fusions.

Indications for use as stated in the FDA summary.

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/K060379 · printed Nov 5, 2026

Cite this page

510(k) Report. “K060379: Ebi 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/K060379

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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