510(k) Report

510(k) · Cleared

Cleared

Synthes Cervical Vertabrae Plates

K792352510(k) TraditionalCleared Dec 6, 197917-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 Synthes · KWQ Appliance, Fixation, Spinal Intervertebral Body

Cleared on Dec 6, 1979 after a 17-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 of the 718 devices in its family, counting itself, has a Class I recall. 717 later devices descend from it.

Decided
Dec 6, 1979
Review
17 days
Class
Class II
Product code
KWQ
Recalls
None
Predicates
0

717 later devices descend from it, 7 citing it directly. 1 of the 718 devices in this family, counting this one, has a Class I recall.

Descendants, by year cleared 2016: 25 descendants cleared2007: 2 descendants cleared1998: 1 descendant cleared2014: 14 descendants cleared2004: 2 descendants cleared2019: 49 descendants cleared2005: 1 descendant cleared2010: 8 descendants cleared2015: 20 descendants cleared2012: 6 descendants cleared2013: 11 descendants cleared2021: 65 descendants cleared, 1 with a Class I recall12018: 37 descendants cleared2023: 81 descendants cleared2006: 1 descendant cleared2020: 67 descendants cleared2017: 43 descendants cleared2008: 1 descendant cleared2024: 75 descendants cleared2011: 10 descendants cleared2022: 65 descendants cleared2025: 68 descendants cleared2026: 65 descendants cleared19801990200020102020
  1. This deviceK792352 Synthes Cervical Vertabrae PlatesDePuy Synthes · 1979
  2. Descendant · cites it directly · 694 of its ownK042499 Orion Anterior Cervical Plating SystemMedtronic Sofamor Danek · 2004
  3. Descendant · 2 generations on · 677 of its ownK042922 Venture Anterior Cervical Plating SystemMedtronic Sofamor Danek, Inc. · 2004
  4. Descendant · 3 generations on · 669 of its ownK061274 Venture Anterior Cervical Plate SystemMedtronic Sofamor Danek · 2006
  5. Descendant · 4 generations on · 637 of its ownK073285 Peek Prevail Cervical Interbody DeviceMedtronic Sofamor Danek USA, Inc. · 2008
  6. Descendant · 5 generations on · 397 of its ownK094042 Peek Prevail Cervical Interbody DeviceMedtronic Sofamor Danek · 2010

Showing 5 of 717 descendants. See all descendants

Descendants cleared per year

1998: 12004: 22005: 12006: 12007: 22008: 12010: 82011: 102012: 62013: 112014: 142015: 202016: 252017: 432018: 372019: 492020: 672021: 652022: 652023: 812024: 752025: 682026: 65
1998high 81 (2023) · low 0 (1999)2026

Class I recalls in this family

  • K211616 ExcelsiusHub9 generations on · 2021

Most influential descendants

Showing 5 of 717 · See all
  • K042499Orion Anterior Cervical Plating SystemMedtronic Sofamor Danek · 2004 · cites it directly694descendants
  • K042922Venture Anterior Cervical Plating SystemMedtronic Sofamor Danek, Inc. · 2004 · 2 generations on677descendants
  • K061274Venture Anterior Cervical Plate SystemMedtronic Sofamor Danek · 2006 · 3 generations on669descendants
  • K073285Peek Prevail Cervical Interbody DeviceMedtronic Sofamor Danek USA, Inc. · 2008 · 4 generations on637descendants
  • K094042Peek Prevail Cervical Interbody DeviceMedtronic Sofamor Danek · 2010 · 5 generations on397descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K792352Synthes Cervical Vertabrae PlatesDePuy Synthes1979—
+1K042499Orion Anterior Cervical Plating SystemMedtronic Sofamor Danek2004—
+2K042922Venture Anterior Cervical Plating SystemMedtronic Sofamor Danek, Inc.2004—
+3K061274Venture Anterior Cervical Plate SystemMedtronic Sofamor Danek2006—
+4K073285Peek Prevail Cervical Interbody DeviceMedtronic Sofamor Danek USA, Inc.2008—
+5K094042Peek Prevail Cervical Interbody DeviceMedtronic Sofamor Danek2010—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199810
200420
200510
200610
200720
200810
201080
2011100
201260
2013110
2014140
2015200
2016250
2017430
2018370
2019490
2020670
2021651
2022650
2023810
2024750
2025680
2026650
FIG. 1 — Lineage of K792352, 1979–2026Source: 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.

1 device in this family has a Class I recall. 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 has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (717)

See all 717

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

NumberDeviceApplicantDecidedDescendants
K042499Orion Anterior Cervical Plating SystemMedtronic Sofamor Danek2004694
K071667Synthes Vectra-One SystemSynthes Spine200726
K1824894CIS® Pinehurst Anterior Cervical Plate systemSolco Biomedical Co., Ltd.20191
K153042TRYPTIK2C-plate Anterior Cervical Plate SystemSpineart20161
K133906C-Jaws Cervical Compressive StapleMedicrea International20141
K051039Basis Spinal SystemMedtronic Sofamor Danek USA, Inc.20050
K981008Simal Cervical Stabilization SystemTop Surgical Products GmbH19980

Has anything in its family been recalled? (1 Class I)

No FDA recall names this device.

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

  • K211616ExcelsiusHubGlobus Medical, Inc. · 2021 · 9 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall

What does this lineage say?

  • Of its descendants, K042499 (Medtronic Sofamor Danek, 2004) has gone furthest, with 694 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 DePuy Synthes

19 FDA decisions under this applicant name. See the company

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  • K233256Robotic Integration InstrumentsDePuy Synthes · 2024
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  • K233254TELIGEN System Navigation Ready InstrumentsDePuy Synthes · 2024
  • K233665DePuy Synthes VOLT Mini Fragment Plating System, DePuy Synthes VOLT Small Fragment Plating SystemDePuy Synthes · 2024

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/K792352 · printed Nov 4, 2026

Cite this page

510(k) Report. “K792352: Synthes Cervical Vertabrae Plates.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K792352

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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