510(k) Report

510(k) · Cleared

Cleared

Eagle Plus Micro Anterior Cervical Plate System

K080191510(k) SpecialCleared Apr 2, 200868-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

Depuy Spine, Inc. · KWQ Appliance, Fixation, Spinal Intervertebral Body

Cleared on Apr 2, 2008 as substantially equivalent to K070994 (Depuy Spine, Inc., 2007) and 1 other predicate after a 68-day review. Its family tree reaches back 3 generations to 1997. 8 later devices descend from it.

Decided
Apr 2, 2008
Review
68 days
Class
Class II
Product code
KWQ
Recalls
None
Predicates
2

Its longest line of descent runs back 3 generations to K971730 (1997). 4 ancestors in all, the oldest K914362 (1992). 8 later devices descend from it, 2 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1992: 1 other ancestor2016: 2 descendants cleared2017: 1 descendant cleared2024: 1 descendant cleared2018: 1 descendant cleared2026: 1 descendant cleared2022: 1 descendant cleared2023: 1 descendant clearedK971730 · Depuy Motech Peak Polyaxial Anterior Cervical Plate System · Depuy, Inc. · 1997K040197 · Eagle Anterior Cervial Plate System · Depuyacromed · 2004K070994 · Eagle + Anterior Cervical Plate System · Depuy Spine, Inc. · 20071990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor 1 generation forward: 2 descendants2 generations forward: 2 descendants3 generations forward: 2 descendants4 generations forward: 1 descendant5 generations forward: 1 descendant K070994 · Eagle + Anterior Cervical Plate System · Depuy Spine, Inc. · 2007K040197 · Eagle Anterior Cervial Plate System · Depuyacromed · 2004K971730 · Depuy Motech Peak Polyaxial Anterior Cervical Plate System · Depuy, Inc. · 19970+5
  1. Root · 3 generations backK971730 Depuy Motech Peak Polyaxial Anterior Cervical Plate SystemDepuy, Inc. · 1997
  2. 2 generations backK040197 Eagle Anterior Cervial Plate SystemDepuyacromed · 2004
  3. 1 generation backK070994 Eagle + Anterior Cervical Plate SystemDepuy Spine, Inc. · 2007
  4. This deviceK080191 Eagle Plus Micro Anterior Cervical Plate SystemDepuy Spine, Inc. · 2008
  5. Descendant · cites it directly · 6 of its ownK153526 Pyrenees Cervical Plate SystemK2m · 2016
  6. Descendant · 2 generations on · 5 of its ownK162664 Pyrenees Cervical Plate SystemK2m, Inc. · 2016
  7. Descendant · 3 generations on · 4 of its ownK182473 PYRENEES Cervical Plate System, BLUE RIDGE Cervical Plate System…K2m, Inc. · 2018
  8. Descendant · 2 generations on · 1 of its ownK242361 OZARK Cervical Plate System; PYRENEES® Cervical Plate System…Stryker Spine · 2024
  9. Descendant · 4 generations on · 1 of its ownK221728 Aviator® Anterior Cervical Plating (ACP) System, LITe® Plate System…Stryker Corporation · 2022

Showing 5 of 8 descendants. See all descendants

Descendants cleared per year

2016: 22017: 12018: 12022: 12023: 12024: 12026: 1
2016high 2 (2016) · low 0 (2019)2026

Most influential descendants

Showing 5 of 8 · See all
  • K153526Pyrenees Cervical Plate SystemK2m · 2016 · cites it directly6descendants
  • K162664Pyrenees Cervical Plate SystemK2m, Inc. · 2016 · 2 generations on5descendants
  • K182473PYRENEES Cervical Plate System, BLUE RIDGE Cervical Plate System, OZARK Cervical Plate…K2m, Inc. · 2018 · 3 generations on4descendants
  • K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine · 2024 · 2 generations on1descendant
  • K221728Aviator® Anterior Cervical Plating (ACP) System, LITe® Plate System, DynaTran™ Anterior…Stryker Corporation · 2022 · 4 generations on1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K971730Depuy Motech Peak Polyaxial Anterior Cervical Plate SystemDepuy, Inc.1997—
−2K040197Eagle Anterior Cervial Plate SystemDepuyacromed2004—
−1K070994Eagle + Anterior Cervical Plate SystemDepuy Spine, Inc.2007—
0 (this device)K080191Eagle Plus Micro Anterior Cervical Plate SystemDepuy Spine, Inc.2008—
+1K153526Pyrenees Cervical Plate SystemK2m2016—
+2K162664Pyrenees Cervical Plate SystemK2m, Inc.2016—
+3K182473PYRENEES Cervical Plate System, BLUE RIDGE Cervical Plate System, OZARK…K2m, Inc.2018—
+2K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal…Stryker Spine2024—
+4K221728Aviator® Anterior Cervical Plating (ACP) System, LITe® Plate System, DynaTran™…Stryker Corporation2022—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199210

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201620
201710
201810
202210
202310
202410
202610
FIG. 1 — Lineage of K080191, 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? (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
*K070994Eagle + Anterior Cervical Plate System
Summary page 1
…CLASSIFICATION NAME: Spinal Intervertebral Body Fixation Orthosis PROPRIETARY NAME: EAGLE Plus Micro Anterior Cervical Plate System PREDICATE DEVICES: K070994 Eagle Plus Anterior Cervical Plate System K914362 Acroplate Anterior Cervical Plate System…
Depuy Spine, Inc.2007—
*K914362Top Cervical Spine Plates & Titanium Bone Screws
Summary page 1
…NAME: EAGLE Plus Micro Anterior Cervical Plate System PREDICATE DEVICES: K070994 Eagle Plus Anterior Cervical Plate System K914362 Acroplate Anterior Cervical Plate System (cleared as the Top Cervical Spine Stabilization…
Acorn Group, Inc.1992—

Also cleared against K070994: 3 other devices →

What descends from it? (8)

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

NumberDeviceApplicantDecidedDescendants
K153526Pyrenees Cervical Plate SystemK2m20166
K171439EAGLE Plus Anterior Cervical Plate System, EAGLE Plus Micro Anterior Cervical Plate…Medos International SARL20170

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 11 years and passes through 3 companies; a new generation was cleared every 3.1 years on median.
  • None of the 4 ancestors has a recall.
  • Of its descendants, K153526 (K2m, 2016) has gone furthest, with 6 descendants of its own.
  • 3 other devices also cite its predicate K070994.

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 EAGLE Plus Micro Anterior Cervical Plate System is intended for anterior cervical intervertebral body fixation. This system is 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), spinal stenosis, 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 K070994

3 other devices cite the same predicate.

  • K171439EAGLE Plus Anterior Cervical Plate System, EAGLE Plus Micro Anterior Cervical Plate System, PULSE Anterior…Medos International SARL · 2017
  • K080646C-Tek Maxan Anterior Cervical Plate SystemBiomet Spine · 20082 recalls
  • K072546Swift Plus Anterior Cervical Plate SystemDepuy Spine, Inc. · 2007

More from Depuy Spine, Inc.

86 FDA decisions under this applicant name. See the company

  • K201831CONFIDENCE Spinal Cement SystemDepuy Spine, Inc. · 2020
  • K142185Expedium Verse Spine SystemDepuy Spine, Inc. · 2014
  • K111136Expedium Spine System, Viper System, Viper 2 SystemDepuy Spine, Inc. · 20121 recall
  • K121020Viper SystemDepuy Spine, Inc. · 2012
  • K110353Mountaineer Oct Spinal SystemDepuy Spine, Inc. · 2011

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/K080191 · printed Nov 6, 2026

Cite this page

510(k) Report. “K080191: Eagle Plus Micro 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/K080191

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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