510(k) Report

510(k) · Cleared

Cleared

Aviator Anterior Cervical Plate (ACP) System

K142237510(k) TraditionalCleared Jan 26, 2015166-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

Stryker Corporation · KWQ Appliance, Fixation, Spinal Intervertebral Body

Cleared on Jan 26, 2015 as substantially equivalent to K083562 (Stryker Corp., 2009) and 4 other predicates after a 166-day review. Its family tree reaches back 3 generations to 2000. 9 later devices descend from it.

Decided
Jan 26, 2015
Review
166 days
Class
Class II
Product code
KWQ
Recalls
None
Predicates
5

Its longest line of descent runs back 3 generations to K000536 (2000). 5 ancestors in all. 9 later devices descend from it, 4 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2004: 1 other ancestor2000: 1 other ancestor2022: 2 descendants cleared2015: 2 descendants cleared2018: 3 descendants cleared2019: 1 descendant cleared2023: 1 descendant clearedK000536 · Synthes Anterior CSLP System · Synthes Spine · 2000 · recalledK062310 · Reflex Hybrid Acp System · Stryker Spine · 2006 · recalledK083562 · Stryker Spine Nulock Anterior Cervical Plating System · Stryker Corp. · 2009200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors 1 generation forward: 4 descendants2 generations forward: 5 descendants K083562 · Stryker Spine Nulock Anterior Cervical Plating System · Stryker Corp. · 2009K062310 · Reflex Hybrid Acp System · Stryker Spine · 2006 · recalledK000536 · Synthes Anterior CSLP System · Synthes Spine · 2000 · recalled0
  1. Root · 3 generations backK000536 Synthes Anterior CSLP SystemSynthes Spine · 2000 · Recalled
  2. 2 generations backK062310 Reflex Hybrid Acp SystemStryker Spine · 2006 · Recalled
  3. 1 generation backK083562 Stryker Spine Nulock Anterior Cervical Plating SystemStryker Corp. · 2009
  4. This deviceK142237 Aviator Anterior Cervical Plate (ACP) SystemStryker Corporation · 2015
  5. Descendant · cites it directly · 4 of its ownK150759 Hyper-C Anterior Cervical Plate SystemDegen Medical · 2015
  6. Descendant · cites it directly · 1 of its ownK221728 Aviator® Anterior Cervical Plating (ACP) System, LITe® Plate System…Stryker Corporation · 2022
  7. Descendant · 2 generations on · 1 of its ownK191786 Cyclops™ Anterior Cervical Plate SystemDegen Medical, Inc. · 2019
  8. Descendant · 2 generations on · 0 of its ownK230424 Omnia Medical Coupler-A™ Anterior Lumbar Plate System; Omnia Medical…Omnia Medical, LLC · 2023
  9. Descendant · 2 generations on · 0 of its ownK213901 Cyclops™ Anterior Cervical Plate SystemDegen Medical · 2022

Showing 5 of 9 descendants. See all descendants

Descendants cleared per year

2015: 22018: 32019: 12022: 22023: 1
2015high 3 (2018) · low 0 (2016)2026

Most influential descendants

Showing 5 of 9 · See all
  • K150759Hyper-C Anterior Cervical Plate SystemDegen Medical · 2015 · cites it directly4descendants
  • K221728Aviator® Anterior Cervical Plating (ACP) System, LITe® Plate System, DynaTran™ Anterior…Stryker Corporation · 2022 · cites it directly1descendant
  • K191786Cyclops™ Anterior Cervical Plate SystemDegen Medical, Inc. · 2019 · 2 generations on1descendant
  • K230424Omnia Medical Coupler-A™ Anterior Lumbar Plate System; Omnia Medical Coupler-L™ Lateral…Omnia Medical, LLC · 2023 · 2 generations on0descendants
  • K213901Cyclops™ Anterior Cervical Plate SystemDegen Medical · 2022 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K000536Synthes Anterior CSLP SystemSynthes Spine20001
−2K062310Reflex Hybrid Acp SystemStryker Spine20062
−1K083562Stryker Spine Nulock Anterior Cervical Plating SystemStryker Corp.2009—
0 (this device)K142237Aviator Anterior Cervical Plate (ACP) SystemStryker Corporation2015—
+1K150759Hyper-C Anterior Cervical Plate SystemDegen Medical2015—
+1K221728Aviator® Anterior Cervical Plating (ACP) System, LITe® Plate System, DynaTran™…Stryker Corporation2022—
+2K191786Cyclops™ Anterior Cervical Plate SystemDegen Medical, Inc.2019—
+2K230424Omnia Medical Coupler-A™ Anterior Lumbar Plate System; Omnia Medical…Omnia Medical, LLC2023—
+2K213901Cyclops™ Anterior Cervical Plate SystemDegen Medical2022—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200010
200410

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201520
201830
201910
202220
202310
FIG. 1 — Lineage of K142237, 2000–2023Source: 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? (5)

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
*K083562Stryker Spine Nulock Anterior Cervical Plating System
Summary page 4
…Classification Spinal Intervertebral Body Fixation Orthosis Name and 21 CFR §888.3060 Number Product Code KWQ Predicate Device  K083562 - Stryker Spine Aviator® Anterior Cervical Plating (ACP) System, (Primary Predicate Device)…
Stryker Corp.2009—
*K062310Reflex Hybrid Acp System
Summary page 4
…KWQ Predicate Device  K083562 - Stryker Spine Aviator® Anterior Cervical Plating (ACP) System, (Primary Predicate Device)  K062310, K040261 – Stryker Spine Reflex® Hybrid ACP System  K000536, K000742 – Synthes Spine Cervical Spine Locking Pl…
Stryker Spine20062
*K040261Reflex Hybrid Anterior Cervical Plate System
Summary page 4
…Predicate Device  K083562 - Stryker Spine Aviator® Anterior Cervical Plating (ACP) System, (Primary Predicate Device)  K062310, K040261 – Stryker Spine Reflex® Hybrid ACP System  K000536, K000742 – Synthes Spine Cervical Spine Locking Plate Syste…
Stryker Spine20044
*K000536Synthes Anterior CSLP System
Summary page 4
…Plating (ACP) System, (Primary Predicate Device)  K062310, K040261 – Stryker Spine Reflex® Hybrid ACP System  K000536, K000742 – Synthes Spine Cervical Spine Locking Plate System Device The purpose of this 510(k) is to summarize the des…
Synthes Spine20001
*K000742Synthes Anterior CSLP System
Summary page 4
…ACP) System, (Primary Predicate Device)  K062310, K040261 – Stryker Spine Reflex® Hybrid ACP System  K000536, K000742 – Synthes Spine Cervical Spine Locking Plate System Device The purpose of this 510(k) is to summarize the design modif…
Synthes Spine2000—

Also cleared against K083562: 2 other devices →

What descends from it? (9)

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

NumberDeviceApplicantDecidedDescendants
K150759Hyper-C Anterior Cervical Plate SystemDegen Medical20154
K221728Aviator® Anterior Cervical Plating (ACP) System, LITe® Plate System, DynaTran™ Anterior…Stryker Corporation20221
K180772Met One Czar Anterior Cervical Plate SystemMet One Technologies20180
K150700ACP 1 Anterior Cervical Plating SystemStryker Corporation20150

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 15 years and passes through 4 companies; a new generation was cleared every 5.8 years on median.
  • 3 of the 5 ancestors have a recall of any class.
  • Of its descendants, K150759 (Degen Medical, 2015) has gone furthest, with 4 descendants of its own.
  • 2 other devices also cite its predicate K083562.

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. 2015, 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 Stryker Spine Aviator® Anterior Cervical Plating (ACP) System is intended for use as an aid in cervical spinal fusion and is intended for unilateral fixation. The Aviator® Anterior Cervical Plating System is intended for anterior intervertebral screw fixation of the cervical spine at levels C2-T1. The system is indicated for temporary stabilization of the anterior spine during the development of cervical spine fusions in patients with the following…

Read the full statement (132 words)

The Stryker Spine Aviator® Anterior Cervical Plating (ACP) System is intended for use as an aid in cervical spinal fusion and is intended for unilateral fixation.

The Aviator® Anterior Cervical Plating System is intended for anterior intervertebral screw fixation of the cervical spine at levels C2-T1. The system is indicated for temporary stabilization of the anterior spine during the development of cervical spine fusions in patients with 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

• Deformities or curvatures (including kyphosis, lordosis, or scoliosis)

• Pseudoarthrosis

• Failed previous fusion

• Decompression of the spinal cord following total or partial cervical vertebrectomy

• Spondylolisthesis

• Spinal Stenosis

Indications for use as stated in the FDA summary.

Also cleared against K083562

2 other devices cite the same predicate.

  • K240484MSFX Mikron Cervical Anterior Plate SystemMikron Makina Sanayi VE Ticaret Ltd. Sti. · 2024
  • K190227Boomerang™ Anterior Cervical Plate SystemChoicespine, LP · 2019

More from Stryker Corporation

87 FDA decisions under this applicant name. See the company

  • K232157Connected OR Hub with Device and Voice Control, SDC4K Information Management System with Device and Voice…Stryker Corporation · 2023
  • K223770Sonopet 1Q 3 7cm 1Q LargeStryker Corporation · 2023
  • K212194Stryker Q Guidance System with Cranial Guidance Software, CranialMask Tracker and Microscope Tracker…Stryker Corporation · 20232 recalls
  • K221728Aviator® Anterior Cervical Plating (ACP) System, LITe® Plate System, DynaTran™ Anterior Cervical Plating…Stryker Corporation · 2022
  • K221074OptaBlate RF Generator, OptaBlate Probes, OptaBlate Microinfuser Infusion DeviceStryker Corporation · 2022

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/K142237 · printed Nov 6, 2026

Cite this page

510(k) Report. “K142237: Aviator Anterior Cervical Plate (ACP) System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K142237

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