510(k) Report

510(k) · Cleared

Cleared

ACP 1 Anterior Cervical Plating System

K150700510(k) TraditionalCleared Jul 15, 2015119-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 Jul 15, 2015 as substantially equivalent to K142237 (Stryker Corporation, 2015) and 2 other predicates after a 119-day review. Its family tree reaches back 6 generations to 1995.

Decided
Jul 15, 2015
Review
119 days
Class
Class II
Product code
KWQ
Recalls
None
Predicates
3

Its longest line of descent runs back 6 generations to K953730 (1995). 16 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 2015: 1 other ancestor2000: 2 other ancestors2009: 1 other ancestor2006: 2 other ancestors2004: 2 other ancestors2007: 1 other ancestor1997: 1 other ancestorK953730 · Codman Anterior Cervical Plate System · Johnson & Johnson Professionals, Inc. · 1995K013877 · Codman Slim-Loc System · Codman & Shurtleff, Inc. · 2001K040655 · Swift Anterior Cervical Plate System · Depuy Spine, Inc. · 2004K072546 · Swift Plus Anterior Cervical Plate System · Depuy Spine, Inc. · 2007K080646 · C-Tek Maxan Anterior Cervical Plate System · Biomet Spine · 2008 · recalledK133518 · Maxan Anterior Cervical Plate System · Biomet Spine (Aka Ebi, LLC) · 2014 · recalled19952000200520102015
Other ancestors, by generation 1 generation back: 2 other ancestors2 generations back: 4 other ancestors3 generations back: 3 other ancestors4 generations back: 1 other ancestor K133518 · Maxan Anterior Cervical Plate System · Biomet Spine (Aka Ebi, LLC) · 2014 · recalledK080646 · C-Tek Maxan Anterior Cervical Plate System · Biomet Spine · 2008 · recalledK072546 · Swift Plus Anterior Cervical Plate System · Depuy Spine, Inc. · 2007K040655 · Swift Anterior Cervical Plate System · Depuy Spine, Inc. · 2004K013877 · Codman Slim-Loc System · Codman & Shurtleff, Inc. · 2001K953730 · Codman Anterior Cervical Plate System · Johnson & Johnson Professionals, Inc. · 1995−50
  1. Root · 6 generations backK953730 Codman Anterior Cervical Plate SystemJohnson & Johnson Professionals, Inc. · 1995
  2. 5 generations backK013877 Codman Slim-Loc SystemCodman & Shurtleff, Inc. · 2001
  3. 4 generations backK040655 Swift Anterior Cervical Plate SystemDepuy Spine, Inc. · 2004
  4. 3 generations backK072546 Swift Plus Anterior Cervical Plate SystemDepuy Spine, Inc. · 2007
  5. 2 generations backK080646 C-Tek Maxan Anterior Cervical Plate SystemBiomet Spine · 2008 · Recalled
  6. 1 generation backK133518 Maxan Anterior Cervical Plate SystemBiomet Spine (Aka Ebi, LLC) · 2014 · Recalled
  7. This deviceK150700 ACP 1 Anterior Cervical Plating SystemStryker Corporation · 2015
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−6K953730Codman Anterior Cervical Plate SystemJohnson & Johnson Professionals, Inc.1995—
−5K013877Codman Slim-Loc SystemCodman & Shurtleff, Inc.2001—
−4K040655Swift Anterior Cervical Plate SystemDepuy Spine, Inc.2004—
−3K072546Swift Plus Anterior Cervical Plate SystemDepuy Spine, Inc.2007—
−2K080646C-Tek Maxan Anterior Cervical Plate SystemBiomet Spine20082
−1K133518Maxan Anterior Cervical Plate SystemBiomet Spine (Aka Ebi, LLC)20141
0 (this device)K150700ACP 1 Anterior Cervical Plating SystemStryker Corporation2015—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199710
200020
200420
200620
200710
200910
201510
FIG. 1 — Lineage of K150700, 1995–2015Source: 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? (3)

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
*K142237Aviator Anterior Cervical Plate (ACP) System
Summary page 4
…l body fixation orthosis Number 21 CFR §888.3060 Product Code KWQ Predicate Devices Primary Predicate: Stryker Spine, Aviator® Anterior Cervical Plating (ACP) System, K142237 Additional Predicates: Synthes Anterior CSLP System, K000742 BioMet MaxAn® Anterior Cervical Plate System, K133518 Device Descr…
Stryker Corporation2015—
*K000742Synthes Anterior CSLP System
Summary page 4
…e KWQ Predicate Devices Primary Predicate: Stryker Spine, Aviator® Anterior Cervical Plating (ACP) System, K142237 Additional Predicates: Synthes Anterior CSLP System, K000742 BioMet MaxAn® Anterior Cervical Plate System, K133518 Device Description The ACP 1™ Anterior Cervical Plating System are one-, t…
Synthes Spine2000—
*K133518Maxan Anterior Cervical Plate System
Summary page 4
…ine, Aviator® Anterior Cervical Plating (ACP) System, K142237 Additional Predicates: Synthes Anterior CSLP System, K000742 BioMet MaxAn® Anterior Cervical Plate System, K133518 Device Description The ACP 1™ Anterior Cervical Plating System are one-, two-, three- and four-level plate configurations rangin…
Biomet Spine (Aka Ebi, LLC)20141

Also cleared against K142237: 3 other devices →

What descends from it?

No later submission names this one as a predicate yet.

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 20 years and passes through 6 companies; a new generation was cleared every 3.3 years on median.
  • 5 of the 16 ancestors have a recall of any class.
  • 3 other devices also cite its predicate K142237.

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 ACP 1™ Anterior Cervical Plating System is intended for use as an aid in cervical spinal fusion and is intended for unilateral fixation. The ACP 1™ 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…

Read the full statement (128 words)

The ACP 1™ Anterior Cervical Plating System is intended for use as an aid in cervical spinal fusion and is intended for

unilateral fixation.

The ACP 1™ 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)

• Pseudarthrosis

• Failed previous fusion

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

• Spondylolisthesis

• Spinal stenosis

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K142237

3 other devices cite the same predicate.

  • K221728Aviator® Anterior Cervical Plating (ACP) System, LITe® Plate System, DynaTran™ Anterior Cervical Plating…Stryker Corporation · 2022
  • K180772Met One Czar Anterior Cervical Plate SystemMet One Technologies · 2018
  • K150759Hyper-C Anterior Cervical Plate SystemDegen Medical · 2015

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/K150700 · printed Nov 6, 2026

Cite this page

510(k) Report. “K150700: ACP 1 Anterior Cervical Plating System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K150700

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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