510(k) Report

510(k) · Cleared

Cleared

Anterior Cervial Plating System

K943523510(k) TraditionalCleared Dec 19, 1994151-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

Smith & Nephew Richards, Inc. · KWQ Appliance, Fixation, Spinal Intervertebral Body

Cleared on Dec 19, 1994 after a 151-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 16 later devices descend from it.

Decided
Dec 19, 1994
Review
151 days
Class
Class II
Product code
KWQ
Recalls
None
Predicates
0

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

Descendants, by year cleared 2013: 1 descendant cleared2017: 1 descendant cleared2020: 3 descendants cleared2023: 3 descendants cleared2018: 2 descendants cleared2015: 2 descendants cleared2024: 2 descendants cleared2022: 1 descendant cleared2026: 1 descendant cleared1990200020102020
  1. This deviceK943523 Anterior Cervial Plating SystemSmith & Nephew Richards, Inc. · 1994
  2. Descendant · cites it directly · 15 of its ownK130030 Zavation Cervical Plate SystemZavation, LLC · 2013
  3. Descendant · 2 generations on · 5 of its ownK172104 Ozark (tm) Cervical Plate SystemK2m, Inc. · 2017
  4. Descendant · 3 generations on · 4 of its ownK182473 PYRENEES Cervical Plate System, BLUE RIDGE Cervical Plate System…K2m, Inc. · 2018
  5. Descendant · 2 generations on · 3 of its ownK150666 uNion Cervical Plate SystemUlrich Medical USA · 2015 · Recalled
  6. Descendant · 3 generations on · 1 of its ownK242361 OZARK Cervical Plate System; PYRENEES® Cervical Plate System…Stryker Spine · 2024

Showing 5 of 16 descendants. See all descendants

Descendants cleared per year

2013: 12015: 22017: 12018: 22020: 32022: 12023: 32024: 22026: 1
2013high 3 (2020) · low 0 (2014)2026

Most influential descendants

Showing 5 of 16 · See all
  • K130030Zavation Cervical Plate SystemZavation, LLC · 2013 · cites it directly15descendants
  • K172104Ozark (tm) Cervical Plate SystemK2m, Inc. · 2017 · 2 generations on5descendants
  • K182473PYRENEES Cervical Plate System, BLUE RIDGE Cervical Plate System, OZARK Cervical Plate…K2m, Inc. · 2018 · 3 generations on4descendants
  • K150666uNion Cervical Plate SystemUlrich Medical USA · 2015 · 2 generations on3descendants
  • K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine · 2024 · 3 generations on1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K943523Anterior Cervial Plating SystemSmith & Nephew Richards, Inc.1994—
+1K130030Zavation Cervical Plate SystemZavation, LLC2013—
+2K172104Ozark (tm) Cervical Plate SystemK2m, Inc.2017—
+3K182473PYRENEES Cervical Plate System, BLUE RIDGE Cervical Plate System, OZARK…K2m, Inc.2018—
+2K150666uNion Cervical Plate SystemUlrich Medical USA20151
+3K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal…Stryker Spine2024—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201310
201520
201710
201820
202030
202210
202330
202420
202610
FIG. 1 — Lineage of K943523, 1994–2026Source: 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? (16)

See all 16

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

NumberDeviceApplicantDecidedDescendants
K130030Zavation Cervical Plate SystemZavation, LLC201315

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, K130030 (Zavation, LLC, 2013) has gone furthest, with 15 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 Smith & Nephew Richards, Inc.

93 FDA decisions under this applicant name. See the company

  • P810020/S005OsteopalSmith & Nephew Richards, Inc. · 1998
  • P810020/S004Palacos E-Flow (Osteopal) Bone CementSmith & Nephew Richards, Inc. · 1998
  • K965224Empower Anterior Direct ScrewsSmith & Nephew Richards, Inc. · 1997
  • K963509Global Taper Tapered Hip System, GT SpectronSmith & Nephew Richards, Inc. · 1997
  • K960444Finn Rod to Rod ConnectorSmith & Nephew Richards, Inc. · 1997

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/K943523 · printed Nov 4, 2026

Cite this page

510(k) Report. “K943523: Anterior Cervial Plating System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K943523

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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