510(k) Report

510(k) · Cleared

Cleared

Uniplate Anterior Cervical Plate System

K042544510(k) TraditionalCleared Nov 23, 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

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

Cleared on Nov 23, 2004 as substantially equivalent to K914362 (Acorn Group, Inc., 1992) after a 64-day review. Its family tree reaches back 1 generation to 1992. 107 later devices descend from it.

Decided
Nov 23, 2004
Review
64 days
Class
Class II
Product code
KWQ
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K914362 (1992). 107 later devices descend from it, 26 citing it directly.

Descendants, by year cleared 2016: 6 descendants cleared2013: 7 descendants cleared2010: 3 descendants cleared2007: 1 descendant cleared2020: 7 descendants cleared2015: 8 descendants cleared2008: 2 descendants cleared2014: 2 descendants cleared2019: 8 descendants cleared2018: 4 descendants cleared2012: 4 descendants cleared2017: 6 descendants cleared2024: 9 descendants cleared2011: 2 descendants cleared2023: 8 descendants cleared2021: 7 descendants cleared2025: 12 descendants cleared2022: 3 descendants cleared2026: 8 descendants clearedK914362 · Top Cervical Spine Plates & Titanium Bone Screws · Acorn Group, Inc. · 19921990200020102020
Descendants, by generation 1 generation forward: 26 descendants2 generations forward: 26 descendants3 generations forward: 17 descendants4 generations forward: 17 descendants5 generations forward: 13 descendants6 generations forward: 7 descendants7 generations forward: 1 descendant K914362 · Top Cervical Spine Plates & Titanium Bone Screws · Acorn Group, Inc. · 19920+5
  1. Root · 1 generation backK914362 Top Cervical Spine Plates & Titanium Bone ScrewsAcorn Group, Inc. · 1992
  2. This deviceK042544 Uniplate Anterior Cervical Plate SystemDepuy Spine, Inc. · 2004
  3. Descendant · cites it directly · 50 of its ownK082273 Uniplate Anterior Cervical Plate SystemDepuy Spine, Inc. · 2008
  4. Descendant · cites it directly · 47 of its ownK100070 Uniplate Anterior Cervical Plate SystemDepuy Spine, Inc. · 2010
  5. Descendant · cites it directly · 26 of its ownK071667 Synthes Vectra-One SystemSynthes Spine · 2007 · Recalled
  6. Descendant · cites it directly · 21 of its ownK121514 Anodyne Anterior Cervical Plate SystemCorelink, LLC · 2012
  7. Descendant · cites it directly · 19 of its ownK072703 Pioneer Slimfuse Anterior Cervical Plating SystemPioneer Surgical Technology · 2008

Showing 5 of 107 descendants. See all descendants

Descendants cleared per year

2007: 12008: 22010: 32011: 22012: 42013: 72014: 22015: 82016: 62017: 62018: 42019: 82020: 72021: 72022: 32023: 82024: 92025: 122026: 8
2007high 12 (2025) · low 0 (2009)2026

Most influential descendants

Showing 5 of 107 · See all
  • K082273Uniplate Anterior Cervical Plate SystemDepuy Spine, Inc. · 2008 · cites it directly50descendants
  • K100070Uniplate Anterior Cervical Plate SystemDepuy Spine, Inc. · 2010 · cites it directly47descendants
  • K071667Synthes Vectra-One SystemSynthes Spine · 2007 · cites it directly26descendants
  • K121514Anodyne Anterior Cervical Plate SystemCorelink, LLC · 2012 · cites it directly21descendants
  • K072703Pioneer Slimfuse Anterior Cervical Plating SystemPioneer Surgical Technology · 2008 · cites it directly19descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K914362Top Cervical Spine Plates & Titanium Bone ScrewsAcorn Group, Inc.1992—
0 (this device)K042544Uniplate Anterior Cervical Plate SystemDepuy Spine, Inc.2004—
+1K082273Uniplate Anterior Cervical Plate SystemDepuy Spine, Inc.2008—
+1K100070Uniplate Anterior Cervical Plate SystemDepuy Spine, Inc.2010—
+1K071667Synthes Vectra-One SystemSynthes Spine20073
+1K121514Anodyne Anterior Cervical Plate SystemCorelink, LLC2012—
+1K072703Pioneer Slimfuse Anterior Cervical Plating SystemPioneer Surgical Technology2008—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200710
200820
201030
201120
201240
201370
201420
201580
201660
201760
201840
201980
202070
202170
202230
202380
202490
2025120
202680
FIG. 1 — Lineage of K042544, 1992–2026Source: 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
*K914362Top Cervical Spine Plates & Titanium Bone Screws
Summary page 1
…DePuy Spine Acroplate Anterior Cervical Plate System (cleared as the Top Cervical Spine Stabilization System) K914362 DEVICE DESCRIPTION: Uniplate Anterior Cervical Plate System consists of an assortment of plates…
Acorn Group, Inc.1992—

Also cleared against K914362: 2 other devices →

What descends from it? (107)

See all 107

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

NumberDeviceApplicantDecidedDescendants
K082273Uniplate Anterior Cervical Plate SystemDepuy Spine, Inc.200850
K100070Uniplate Anterior Cervical Plate SystemDepuy Spine, Inc.201047
K071667Synthes Vectra-One SystemSynthes Spine200726
K121514Anodyne Anterior Cervical Plate SystemCorelink, LLC201221
K072703Pioneer Slimfuse Anterior Cervical Plating SystemPioneer Surgical Technology200819
K130030Zavation Cervical Plate SystemZavation, LLC201315
K151553Anterior Cervical Plate SystemOsteomed Implantes, Ltda201611
K150983Pyrenees Cervical Plate SystemK2m20157
K162664Pyrenees Cervical Plate SystemK2m, Inc.20165
K160702ZION Anterior Cervical Fixation SystemAstura Medical20163

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, K082273 (Depuy Spine, Inc., 2008) has gone furthest, with 50 descendants of its own.
  • 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.

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 Uniplate 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.

Indication includes 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 K914362

2 other devices cite the same predicate.

  • K123167Depuy Pulse Anterior Cervical in-Line Plate SystemMedos International SARL · 2012
  • K080191Eagle Plus Micro Anterior Cervical Plate SystemDepuy Spine, Inc. · 2008

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/K042544 · printed Nov 5, 2026

Cite this page

510(k) Report. “K042544: Uniplate Anterior Cervical Plate System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K042544

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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