510(k) Report

510(k) · Cleared

Cleared

Codman Anterior Cervical Plate System

K953730510(k) TraditionalCleared Nov 9, 199591-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

Johnson & Johnson Professionals, Inc. · KWQ Appliance, Fixation, Spinal Intervertebral Body

Cleared on Nov 9, 1995 after a 91-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 258 later devices descend from it.

Decided
Nov 9, 1995
Review
91 days
Class
Class II
Product code
KWQ
Recalls
None
Predicates
0

258 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2001: 1 descendant cleared2016: 9 descendants cleared2005: 3 descendants cleared2019: 14 descendants cleared2011: 6 descendants cleared2004: 1 descendant cleared2012: 5 descendants cleared2010: 3 descendants cleared2017: 6 descendants cleared2008: 4 descendants cleared2007: 1 descendant cleared2013: 9 descendants cleared2020: 20 descendants cleared2015: 8 descendants cleared2018: 6 descendants cleared2022: 21 descendants cleared2024: 29 descendants cleared2009: 1 descendant cleared2021: 13 descendants cleared2025: 33 descendants cleared2014: 8 descendants cleared2026: 29 descendants cleared2023: 28 descendants cleared1995200020052010201520202025
  1. This deviceK953730 Codman Anterior Cervical Plate SystemJohnson & Johnson Professionals, Inc. · 1995
  2. Descendant · cites it directly · 257 of its ownK013877 Codman Slim-Loc SystemCodman & Shurtleff, Inc. · 2001
  3. Descendant · 2 generations on · 217 of its ownK040655 Swift Anterior Cervical Plate SystemDepuy Spine, Inc. · 2004
  4. Descendant · 3 generations on · 195 of its ownK072546 Swift Plus Anterior Cervical Plate SystemDepuy Spine, Inc. · 2007
  5. Descendant · 3 generations on · 193 of its ownK080646 C-Tek Maxan Anterior Cervical Plate SystemBiomet Spine · 2008 · Recalled
  6. Descendant · 4 generations on · 132 of its ownK133475 Struxxure Anterior Cervical Plate and ScrewsNexxt Spine, LLC · 2013

Showing 5 of 258 descendants. See all descendants

Descendants cleared per year

2001: 12004: 12005: 32007: 12008: 42009: 12010: 32011: 62012: 52013: 92014: 82015: 82016: 92017: 62018: 62019: 142020: 202021: 132022: 212023: 282024: 292025: 332026: 29
2001high 33 (2025) · low 0 (2002)2026

Most influential descendants

Showing 5 of 258 · See all
  • K013877Codman Slim-Loc SystemCodman & Shurtleff, Inc. · 2001 · cites it directly257descendants
  • K040655Swift Anterior Cervical Plate SystemDepuy Spine, Inc. · 2004 · 2 generations on217descendants
  • K072546Swift Plus Anterior Cervical Plate SystemDepuy Spine, Inc. · 2007 · 3 generations on195descendants
  • K080646C-Tek Maxan Anterior Cervical Plate SystemBiomet Spine · 2008 · 3 generations on193descendants
  • K133475Struxxure Anterior Cervical Plate and ScrewsNexxt Spine, LLC · 2013 · 4 generations on132descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K953730Codman Anterior Cervical Plate SystemJohnson & Johnson Professionals, Inc.1995—
+1K013877Codman Slim-Loc SystemCodman & Shurtleff, Inc.2001—
+2K040655Swift Anterior Cervical Plate SystemDepuy Spine, Inc.2004—
+3K072546Swift Plus Anterior Cervical Plate SystemDepuy Spine, Inc.2007—
+3K080646C-Tek Maxan Anterior Cervical Plate SystemBiomet Spine20082
+4K133475Struxxure Anterior Cervical Plate and ScrewsNexxt Spine, LLC2013—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200110
200410
200530
200710
200840
200910
201030
201160
201250
201390
201480
201580
201690
201760
201860
2019140
2020200
2021130
2022210
2023280
2024290
2025330
2026290
FIG. 1 — Lineage of K953730, 1995–2026Source: 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), 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?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (258)

See all 258

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K013877Codman Slim-Loc SystemCodman & Shurtleff, Inc.2001257

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, K013877 (Codman & Shurtleff, Inc., 2001) has gone furthest, with 257 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—
Cite this page

510(k) Report. “K953730: Codman Anterior Cervical 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/K953730

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026