510(k) Report

510(k) · Cleared

Cleared

Eagle Anterior Cervial Plate System

K040197510(k) SpecialCleared Apr 2, 200464-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

Depuyacromed · KWQ Appliance, Fixation, Spinal Intervertebral Body

Cleared on Apr 2, 2004 as substantially equivalent to K971730 (Depuy, Inc., 1997) after a 64-day review. Its family tree reaches back 1 generation to 1997. 215 later devices descend from it.

Decided
Apr 2, 2004
Review
64 days
Class
Class II
Product code
KWQ
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K971730 (1997). 215 later devices descend from it, 5 citing it directly.

Descendants, by year cleared 2007: 2 descendants cleared2016: 10 descendants cleared2008: 4 descendants cleared2010: 1 descendant cleared2017: 5 descendants cleared2021: 12 descendants cleared2025: 29 descendants cleared2019: 13 descendants cleared2013: 6 descendants cleared2015: 5 descendants cleared2014: 6 descendants cleared2011: 1 descendant cleared2018: 4 descendants cleared2012: 2 descendants cleared2024: 27 descendants cleared2023: 26 descendants cleared2020: 18 descendants cleared2022: 17 descendants cleared2026: 27 descendants clearedK971730 · Depuy Motech Peak Polyaxial Anterior Cervical Plate System · Depuy, Inc. · 19971995200020052010201520202025
Descendants, by generation 1 generation forward: 5 descendants2 generations forward: 24 descendants3 generations forward: 29 descendants4 generations forward: 29 descendants5 generations forward: 20 descendants6 generations forward: 33 descendants7 generations forward: 33 descendants8 generations forward: 23 descendants9 generations forward: 14 descendants10 generations forward: 4 descendants11 generations forward: 1 descendant K971730 · Depuy Motech Peak Polyaxial Anterior Cervical Plate System · Depuy, Inc. · 19970+5+10
  1. Root · 1 generation backK971730 Depuy Motech Peak Polyaxial Anterior Cervical Plate SystemDepuy, Inc. · 1997
  2. This deviceK040197 Eagle Anterior Cervial Plate SystemDepuyacromed · 2004
  3. Descendant · cites it directly · 204 of its ownK070994 Eagle + Anterior Cervical Plate SystemDepuy Spine, Inc. · 2007
  4. Descendant · 2 generations on · 195 of its ownK072546 Swift Plus Anterior Cervical Plate SystemDepuy Spine, Inc. · 2007
  5. Descendant · cites it directly · 193 of its ownK080646 C-Tek Maxan Anterior Cervical Plate SystemBiomet Spine · 2008 · Recalled
  6. Descendant · 2 generations on · 132 of its ownK133475 Struxxure Anterior Cervical Plate and ScrewsNexxt Spine, LLC · 2013
  7. Descendant · 3 generations on · 106 of its ownK141376 Inertia Pedicle Screw System, Honour Spacer System, Facet Fixx…Nexxt Spine, LLC · 2014

Showing 5 of 215 descendants. See all descendants

Descendants cleared per year

2007: 22008: 42010: 12011: 12012: 22013: 62014: 62015: 52016: 102017: 52018: 42019: 132020: 182021: 122022: 172023: 262024: 272025: 292026: 27
2007high 29 (2025) · low 0 (2009)2026

Most influential descendants

Showing 5 of 215 · See all
  • K070994Eagle + Anterior Cervical Plate SystemDepuy Spine, Inc. · 2007 · cites it directly204descendants
  • K072546Swift Plus Anterior Cervical Plate SystemDepuy Spine, Inc. · 2007 · 2 generations on195descendants
  • 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
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K971730Depuy Motech Peak Polyaxial Anterior Cervical Plate SystemDepuy, Inc.1997—
0 (this device)K040197Eagle Anterior Cervial Plate SystemDepuyacromed2004—
+1K070994Eagle + Anterior Cervical Plate SystemDepuy Spine, Inc.2007—
+2K072546Swift Plus Anterior Cervical Plate SystemDepuy Spine, Inc.2007—
+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—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200720
200840
201010
201110
201220
201360
201460
201550
2016100
201750
201840
2019130
2020180
2021120
2022170
2023260
2024270
2025290
2026270
FIG. 1 — Lineage of K040197, 1997–2026Source: 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? (1)

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
*K971730Depuy Motech Peak Polyaxial Anterior Cervical Plate System
Summary page 1
…rthosis PROPRIETARY NAME: Eagle Anterior Cervical Plate System PREDICATE DEVICES: Peak Polyaxial Anterior Cervical Plate System (K971730) DEVICE DESCRIPTION: The Eagle Anterior Cervical Plate System consists of an assortment of plates…
Depuy, Inc.1997—

Also cleared against K971730: 8 other devices →

What descends from it? (215)

See all 215

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

NumberDeviceApplicantDecidedDescendants
K070994Eagle + Anterior Cervical Plate SystemDepuy Spine, Inc.2007204
K080646C-Tek Maxan Anterior Cervical Plate SystemBiomet Spine2008193
K082273Uniplate Anterior Cervical Plate SystemDepuy Spine, Inc.200850
K100070Uniplate Anterior Cervical Plate SystemDepuy Spine, Inc.201047
K153526Pyrenees Cervical Plate SystemK2m20166

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?

  • Its one ancestor has no recall.
  • Of its descendants, K070994 (Depuy Spine, Inc., 2007) has gone furthest, with 204 descendants of its own.
  • 8 other devices also cite its predicate K971730.

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 Eagle Anterior Cervical Plate System is intended for anterior cervical intervertebral body fixation. These systems are indicated for patients in which stability is desired following anterior cervical fusion for the indications listed below. The intended levels for treatment range from C2 to T1.

Indications include symptomatic cervical spondylosis, trauma, fracture, post-traumatic kyphosis or lordosis, tumor, degenerative disc disease (defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies), re-operation for failed fusion, or instability following surgery for the above indications.

Indications for use as stated in the FDA summary.

Also cleared against K971730

8 other devices cite the same predicate.

  • K150983Pyrenees Cervical Plate SystemK2m · 2015
  • K103505Altum Anterior Cervical PlateSpinecraft, LLC · 20111 recall
  • K092474Pyrenees Cervical Plate System, Semi-Constrained ScrewsK2m, Inc. · 2010
  • K063544Modification to Pyrenees Cervical Plate SystemK2m, Inc. · 2007
  • K043066Pioneer Anterior Cervical Plate SystemPioneer Surgical Technology · 2005
  • K040721Assure Anterior Cervical Plate SystemGlobus Medical, Inc. · 2004

More from Depuyacromed

48 FDA decisions under this applicant name. See the company

  • K031635Depuy Acromed VBR SystemDepuyacromed · 2003
  • K030833Depuy Acromed VBR SystemDepuyacromed · 2003
  • K030383Modification to Moss Miami Spinal System Polyaxial ScrewsDepuyacromed · 2003
  • K030249Surgical Titanium Mesh SystemDepuyacromed · 2003
  • K030103Summit Oct Spinal System Minipolyaxial ScrewsDepuyacromed · 2003

Recent decisions in KWQ

The KWQ category page

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  • K252776ARIES Anterior Cervical Plate SystemsZheJiang Decans Medical Devices Co., Ltd. · 2026
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https://510kreport.com/device/K040197 · printed Nov 6, 2026

Cite this page

510(k) Report. “K040197: Eagle Anterior Cervial 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/K040197

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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