510(k) Report

510(k) · Cleared

Cleared

Top Cervical Spine Plates & Titanium Bone Screws

K914362510(k) TraditionalCleared Apr 29, 1992211-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

Acorn Group, Inc. · KWQ Appliance, Fixation, Spinal Intervertebral Body

Cleared on Apr 29, 1992 after a 211-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 110 later devices descend from it.

Decided
Apr 29, 1992
Review
211 days
Class
Class II
Product code
KWQ
Recalls
None
Predicates
0

110 later devices descend from it, 3 citing it directly.

Descendants, by year cleared 2004: 1 descendant cleared2008: 3 descendants cleared2012: 4 descendants cleared2016: 7 descendants cleared2013: 7 descendants cleared2010: 3 descendants cleared2007: 1 descendant cleared2020: 7 descendants cleared2015: 8 descendants cleared2014: 2 descendants cleared2019: 8 descendants cleared2018: 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 cleared1990200020102020
  1. This deviceK914362 Top Cervical Spine Plates & Titanium Bone ScrewsAcorn Group, Inc. · 1992
  2. Descendant · cites it directly · 107 of its ownK042544 Uniplate Anterior Cervical Plate SystemDepuy Spine, Inc. · 2004
  3. Descendant · 2 generations on · 50 of its ownK082273 Uniplate Anterior Cervical Plate SystemDepuy Spine, Inc. · 2008
  4. Descendant · 2 generations on · 47 of its ownK100070 Uniplate Anterior Cervical Plate SystemDepuy Spine, Inc. · 2010
  5. Descendant · 2 generations on · 26 of its ownK071667 Synthes Vectra-One SystemSynthes Spine · 2007 · Recalled
  6. Descendant · 2 generations on · 21 of its ownK121514 Anodyne Anterior Cervical Plate SystemCorelink, LLC · 2012

Showing 5 of 110 descendants. See all descendants

Descendants cleared per year

2004: 12007: 12008: 32010: 32011: 22012: 42013: 72014: 22015: 82016: 72017: 62018: 42019: 82020: 72021: 72022: 32023: 82024: 92025: 122026: 8
2004high 12 (2025) · low 0 (2005)2026

Most influential descendants

Showing 5 of 110 · See all
  • K042544Uniplate Anterior Cervical Plate SystemDepuy Spine, Inc. · 2004 · cites it directly107descendants
  • K082273Uniplate Anterior Cervical Plate SystemDepuy Spine, Inc. · 2008 · 2 generations on50descendants
  • K100070Uniplate Anterior Cervical Plate SystemDepuy Spine, Inc. · 2010 · 2 generations on47descendants
  • K071667Synthes Vectra-One SystemSynthes Spine · 2007 · 2 generations on26descendants
  • K121514Anodyne Anterior Cervical Plate SystemCorelink, LLC · 2012 · 2 generations on21descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K914362Top Cervical Spine Plates & Titanium Bone ScrewsAcorn Group, Inc.1992—
+1K042544Uniplate Anterior Cervical Plate SystemDepuy Spine, Inc.2004—
+2K082273Uniplate Anterior Cervical Plate SystemDepuy Spine, Inc.2008—
+2K100070Uniplate Anterior Cervical Plate SystemDepuy Spine, Inc.2010—
+2K071667Synthes Vectra-One SystemSynthes Spine20073
+2K121514Anodyne Anterior Cervical Plate SystemCorelink, LLC2012—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200410
200710
200830
201030
201120
201240
201370
201420
201580
201670
201760
201840
201980
202070
202170
202230
202380
202490
2025120
202680
FIG. 1 — Lineage of K914362, 1992–2026Source: 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), 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?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (110)

See all 110

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

NumberDeviceApplicantDecidedDescendants
K042544Uniplate Anterior Cervical Plate SystemDepuy Spine, Inc.2004107
K080191Eagle Plus Micro Anterior Cervical Plate SystemDepuy Spine, Inc.20088
K123167Depuy Pulse Anterior Cervical in-Line Plate SystemMedos International SARL20120

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?

  • Of its descendants, K042544 (Depuy Spine, Inc., 2004) has gone furthest, with 107 descendants of its own.

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—

More from Acorn Group, Inc.

4 FDA decisions under this applicant name. See the company

  • K912905LaryngoscopeAcorn Group, Inc. · 1991
  • K904126VisiraserAcorn Group, Inc. · 1990
  • K900430Irrigation and Suction ApparatusAcorn Group, Inc. · 1990

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/K914362 · printed Nov 6, 2026

Cite this page

510(k) Report. “K914362: Top Cervical Spine Plates & Titanium Bone Screws.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K914362

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
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026