510(k) Report

510(k) · Cleared

Cleared

Synthes (U.S.a.) Anterior Spinal Plate

K925351510(k) TraditionalCleared Nov 5, 1993379-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

Synthes (Usa) · KWQ Appliance, Fixation, Spinal Intervertebral Body

Cleared on Nov 5, 1993 after a 379-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 56 later devices descend from it.

Decided
Nov 5, 1993
Review
379 days
Class
Class II
Product code
KWQ
Recalls
None
Predicates
0

56 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 1997: 1 descendant cleared1998: 1 descendant cleared2008: 7 descendants cleared2001: 2 descendants cleared2004: 3 descendants cleared2017: 6 descendants cleared2000: 1 descendant cleared2012: 2 descendants cleared2007: 1 descendant cleared2015: 2 descendants cleared2021: 2 descendants cleared2009: 1 descendant cleared2005: 1 descendant cleared2013: 2 descendants cleared2026: 3 descendants cleared2006: 1 descendant cleared2019: 3 descendants cleared2018: 1 descendant cleared2023: 6 descendants cleared2020: 2 descendants cleared2022: 1 descendant cleared2025: 3 descendants cleared2024: 4 descendants cleared1990200020102020
  1. This deviceK925351 Synthes (U.S.a.) Anterior Spinal PlateSynthes (Usa) · 1993
  2. Descendant · cites it directly · 54 of its ownK970048 Synthes (Usa)Titanium Locking Plate System (Tilps)Synthes (Usa) · 1997
  3. Descendant · 2 generations on · 43 of its ownK010466 Tether AcfsTheken Surgical,Llc · 2001
  4. Descendant · 3 generations on · 21 of its ownK121514 Anodyne Anterior Cervical Plate SystemCorelink, LLC · 2012
  5. Descendant · 4 generations on · 18 of its ownK163104 Terrace™ Anterior Cervical Plate SystemCorelink, LLC · 2017
  6. Descendant · 5 generations on · 15 of its ownK190016 Lateral Plate SystemCorelink, LLC · 2019

Showing 5 of 56 descendants. See all descendants

Descendants cleared per year

1997: 11998: 12000: 12001: 22004: 32005: 12006: 12007: 12008: 72009: 12012: 22013: 22015: 22017: 62018: 12019: 32020: 22021: 22022: 12023: 62024: 42025: 32026: 3
1997high 7 (2008) · low 0 (1999)2026

Most influential descendants

Showing 5 of 56 · See all
  • K970048Synthes (Usa)Titanium Locking Plate System (Tilps)Synthes (Usa) · 1997 · cites it directly54descendants
  • K010466Tether AcfsTheken Surgical,Llc · 2001 · 2 generations on43descendants
  • K121514Anodyne Anterior Cervical Plate SystemCorelink, LLC · 2012 · 3 generations on21descendants
  • K163104Terrace™ Anterior Cervical Plate SystemCorelink, LLC · 2017 · 4 generations on18descendants
  • K190016Lateral Plate SystemCorelink, LLC · 2019 · 5 generations on15descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K925351Synthes (U.S.a.) Anterior Spinal PlateSynthes (Usa)1993—
+1K970048Synthes (Usa)Titanium Locking Plate System (Tilps)Synthes (Usa)1997—
+2K010466Tether AcfsTheken Surgical,Llc2001—
+3K121514Anodyne Anterior Cervical Plate SystemCorelink, LLC2012—
+4K163104Terrace™ Anterior Cervical Plate SystemCorelink, LLC2017—
+5K190016Lateral Plate SystemCorelink, LLC2019—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199710
199810
200010
200120
200430
200510
200610
200710
200870
200910
201220
201320
201520
201760
201810
201930
202020
202120
202210
202360
202440
202530
202630
FIG. 1 — Lineage of K925351, 1993–2026Source: 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? (56)

See all 56

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

NumberDeviceApplicantDecidedDescendants
K970048Synthes (Usa)Titanium Locking Plate System (Tilps)Synthes (Usa)199754
K974525Synthes Spine Anterior Thoracolumbar Rod Clamp (Atrc) SystemSynthes Spine19980

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, K970048 (Synthes (Usa), 1997) has gone furthest, with 54 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—

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406 FDA decisions under this applicant name. See the company

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Recent decisions in KWQ

The KWQ category page

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  • 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/K925351 · printed Nov 6, 2026

Cite this page

510(k) Report. “K925351: Synthes (U.S.a.) Anterior Spinal Plate.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K925351

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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