510(k) Report

510(k) · Cleared

Cleared

Depuy Pulse Anterior Cervical in-Line Plate System

K123167510(k) TraditionalCleared Dec 28, 201280-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

Medos International SARL · KWQ Appliance, Fixation, Spinal Intervertebral Body

Cleared on Dec 28, 2012 as substantially equivalent to K914362 (Acorn Group, Inc., 1992) and 3 other predicates after an 80-day review. Its family tree reaches back 5 generations to 1995.

Decided
Dec 28, 2012
Review
80 days
Class
Class II
Product code
KWQ
Recalls
None
Predicates
4

Its longest line of descent runs back 5 generations to K953730 (1995). 10 ancestors in all, the oldest K914362 (1992). No later device cites it as a predicate yet.

Other ancestors, by year cleared 2004: 2 other ancestors1992: 1 other ancestor2008: 1 other ancestor1997: 1 other ancestorK953730 · Codman Anterior Cervical Plate System · Johnson & Johnson Professionals, Inc. · 1995K013877 · Codman Slim-Loc System · Codman & Shurtleff, Inc. · 2001K052552 · Hybrid Anterior Cervical Plate System · Depuy Spine, Inc. · 2005 · recalledK103491 · Skyline Anterior Cervical Plate System · A Johnson & Johnson Company · 2011K112724 · Depuy Pulse Anterior Cerical Plate System · Medos International SARL · 201119901995200020052010
Other ancestors, by generation 1 generation back: 2 other ancestors2 generations back: 1 other ancestor3 generations back: 1 other ancestor4 generations back: 1 other ancestor K112724 · Depuy Pulse Anterior Cerical Plate System · Medos International SARL · 2011K103491 · Skyline Anterior Cervical Plate System · A Johnson & Johnson Company · 2011K052552 · Hybrid Anterior Cervical Plate System · Depuy Spine, Inc. · 2005 · recalledK013877 · Codman Slim-Loc System · Codman & Shurtleff, Inc. · 2001K953730 · Codman Anterior Cervical Plate System · Johnson & Johnson Professionals, Inc. · 1995−50
  1. Root · 5 generations backK953730 Codman Anterior Cervical Plate SystemJohnson & Johnson Professionals, Inc. · 1995
  2. 4 generations backK013877 Codman Slim-Loc SystemCodman & Shurtleff, Inc. · 2001
  3. 3 generations backK052552 Hybrid Anterior Cervical Plate SystemDepuy Spine, Inc. · 2005 · Recalled
  4. 2 generations backK103491 Skyline Anterior Cervical Plate SystemA Johnson & Johnson Company · 2011
  5. 1 generation backK112724 Depuy Pulse Anterior Cerical Plate SystemMedos International SARL · 2011
  6. This deviceK123167 Depuy Pulse Anterior Cervical in-Line Plate SystemMedos International SARL · 2012
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−5K953730Codman Anterior Cervical Plate SystemJohnson & Johnson Professionals, Inc.1995—
−4K013877Codman Slim-Loc SystemCodman & Shurtleff, Inc.2001—
−3K052552Hybrid Anterior Cervical Plate SystemDepuy Spine, Inc.20057
−2K103491Skyline Anterior Cervical Plate SystemA Johnson & Johnson Company2011—
−1K112724Depuy Pulse Anterior Cerical Plate SystemMedos International SARL2011—
0 (this device)K123167Depuy Pulse Anterior Cervical in-Line Plate SystemMedos International SARL2012—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199210
199710
200420
200810
FIG. 1 — Lineage of K123167, 1995–2012Source: 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
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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
*K914362Top Cervical Spine Plates & Titanium Bone Screws
Summary page 1
…on Name: Spinal Intervertebral Body Fixation Orthosis Regulation Number: 888.3060 Predicate Devices: AcroPlate Anterior Cervical Plate System (DePuy Spine) - K914362 Uniplate Anterior Cervical Plate System (DePuy Spine) - K042544 Skyline Anterior Ce…
Acorn Group, Inc.1992—
*K042544Uniplate Anterior Cervical Plate System
Summary page 1
…Predicate Devices: AcroPlate Anterior Cervical Plate System (DePuy Spine) - K914362 Uniplate Anterior Cervical Plate System (DePuy Spine) - K042544 Skyline Anterior Cervical Plate System (DePuy Spine) - K 103491 PULSE Anterior Cerv…
Depuy Spine, Inc.2004—
*K103491Skyline Anterior Cervical Plate System
Summary page 1
…4362 Uniplate Anterior Cervical Plate System (DePuy Spine) - K042544 Skyline Anterior Cervical Plate System (DePuy Spine) - K 103491 PULSE Anterior Cervical Plate System (DePuy Spine) - K 112724 Device Description: The DePuy PULSE Ant…
A Johnson & Johnson Company2011—
*K112724Depuy Pulse Anterior Cerical Plate System
Summary page 1
…042544 Skyline Anterior Cervical Plate System (DePuy Spine) - K 103491 PULSE Anterior Cervical Plate System (DePuy Spine) - K 112724 Device Description: The DePuy PULSE Anterior Cervical In-Line Plate System is intended for anterior s…
Medos International SARL2011—

Also cleared against K914362: 2 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 17 years and passes through 5 companies; a new generation was cleared every 3.8 years on median.
  • 1 of the 10 ancestors has a recall of any class.
  • 2 other devices also cite its predicate K914362.

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. 2012, 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 DePuy PULSE Anterior Cervical In-Line 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 TI.

Indication includes symptomatic cervical spondylosis, trauma, fracture, post-traimatic 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 K914362

2 other devices cite the same predicate.

  • K080191Eagle Plus Micro Anterior Cervical Plate SystemDepuy Spine, Inc. · 2008
  • K042544Uniplate Anterior Cervical Plate SystemDepuy Spine, Inc. · 2004

More from Medos International SARL

96 FDA decisions under this applicant name. See the company

  • K254157CROSSNAV Navigation Enabled Instruments for Disc Preparation and InterbodyMedos International SARL · 2026
  • K260240SYMPHONY Navigation Ready InstrumentsMedos International SARL · 2026
  • K253249TriALTIS™ Spine SystemMedos International SARL · 2025
  • K243249TriALTIS™ Spine SystemMedos International SARL · 2025
  • K241893CROSSNAV Navigation Enabled Instruments and UNAS Navigation ArraysMedos International SARL · 2024

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/K123167 · printed Nov 6, 2026

Cite this page

510(k) Report. “K123167: Depuy Pulse Anterior Cervical in-Line 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/K123167

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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