510(k) Report

510(k) · Cleared

Cleared

Synthes (U.S.a.) Anterior Cervical Vertebrae Plate

K926453510(k) TraditionalCleared Oct 12, 1993292-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 Oct 12, 1993 after a 292-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 of the 760 devices in its family, counting itself, has a Class I recall. 759 later devices descend from it.

Decided
Oct 12, 1993
Review
292 days
Class
Class II
Product code
KWQ
Recalls
None
Predicates
0

759 later devices descend from it, 15 citing it directly. 1 of the 760 devices in this family, counting this one, has a Class I recall.

Descendants, by year cleared 2016: 23 descendants cleared2007: 5 descendants cleared1999: 1 descendant cleared2010: 7 descendants cleared2004: 7 descendants cleared1997: 2 descendants cleared2019: 41 descendants cleared2009: 6 descendants cleared2012: 24 descendants cleared2014: 18 descendants cleared2008: 9 descendants cleared2018: 35 descendants cleared2015: 31 descendants cleared2013: 16 descendants cleared2020: 52 descendants cleared2021: 51 descendants cleared, 1 with a Class I recall12023: 88 descendants cleared2022: 62 descendants cleared2001: 2 descendants cleared2017: 41 descendants cleared2000: 2 descendants cleared2011: 7 descendants cleared2005: 7 descendants cleared2002: 5 descendants cleared2003: 4 descendants cleared2024: 81 descendants cleared2006: 1 descendant cleared2026: 63 descendants cleared2025: 68 descendants cleared1990200020102020
  1. This deviceK926453 Synthes (U.S.a.) Anterior Cervical Vertebrae PlateSynthes (Usa) · 1993
  2. Descendant · cites it directly · 531 of its ownK971883 Synthes Spine Small Stature Anterior Cervical Vertebrae Plate SystemSynthes (Usa) · 1997 · Recalled
  3. Descendant · 2 generations on · 348 of its ownK103287 Synthes 6.0 Cocr and CPT TI-3 RodsSynthes Spine · 2011
  4. Descendant · cites it directly · 313 of its ownK990005 Spinal Concepts, Inc. (Sci) Anterior Cervical Plate SystemSpinal Concepts, Inc. · 1999 · Recalled
  5. Descendant · 2 generations on · 289 of its ownK000486 Abc Cervical Plating SystemAesculap, Inc. · 2000
  6. Descendant · 3 generations on · 260 of its ownK113395 Revere 4.5 Stabilization SystemGlobus Medical, Inc. · 2012

Showing 5 of 759 descendants. See all descendants

Descendants cleared per year

1997: 21999: 12000: 22001: 22002: 52003: 42004: 72005: 72006: 12007: 52008: 92009: 62010: 72011: 72012: 242013: 162014: 182015: 312016: 232017: 412018: 352019: 412020: 522021: 512022: 622023: 882024: 812025: 682026: 63
1997high 88 (2023) · low 0 (1998)2026

Class I recalls in this family

  • K211616 ExcelsiusHub6 generations on · 2021

Most influential descendants

Showing 5 of 759 · See all
  • K971883Synthes Spine Small Stature Anterior Cervical Vertebrae Plate SystemSynthes (Usa) · 1997 · cites it directly531descendants
  • K103287Synthes 6.0 Cocr and CPT TI-3 RodsSynthes Spine · 2011 · 2 generations on348descendants
  • K990005Spinal Concepts, Inc. (Sci) Anterior Cervical Plate SystemSpinal Concepts, Inc. · 1999 · cites it directly313descendants
  • K000486Abc Cervical Plating SystemAesculap, Inc. · 2000 · 2 generations on289descendants
  • K113395Revere 4.5 Stabilization SystemGlobus Medical, Inc. · 2012 · 3 generations on260descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K926453Synthes (U.S.a.) Anterior Cervical Vertebrae PlateSynthes (Usa)1993—
+1K971883Synthes Spine Small Stature Anterior Cervical Vertebrae Plate SystemSynthes (Usa)19971
+2K103287Synthes 6.0 Cocr and CPT TI-3 RodsSynthes Spine2011—
+1K990005Spinal Concepts, Inc. (Sci) Anterior Cervical Plate SystemSpinal Concepts, Inc.19991
+2K000486Abc Cervical Plating SystemAesculap, Inc.2000—
+3K113395Revere 4.5 Stabilization SystemGlobus Medical, Inc.2012—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199720
199910
200020
200120
200250
200340
200470
200570
200610
200750
200890
200960
201070
201170
2012240
2013160
2014180
2015310
2016230
2017410
2018350
2019410
2020520
2021511
2022620
2023880
2024810
2025680
2026630
FIG. 1 — Lineage of K926453, 1993–2026Source: 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.

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? (759)

See all 759

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

NumberDeviceApplicantDecidedDescendants
K971883Synthes Spine Small Stature Anterior Cervical Vertebrae Plate SystemSynthes (Usa)1997531
K990005Spinal Concepts, Inc. (Sci) Anterior Cervical Plate SystemSpinal Concepts, Inc.1999313
K040721Assure Anterior Cervical Plate SystemGlobus Medical, Inc.2004178
K970048Synthes (Usa)Titanium Locking Plate System (Tilps)Synthes (Usa)199754
K071667Synthes Vectra-One SystemSynthes Spine200726
K083338Cardiff Anterior Cervical Plate SystemSeaspine, Inc.200916
K072650Ist Anterior Cervical Plate SystemInnovative Spinal Technologies, Inc.20078
K160604Cure™ Anterior Cervical Plate (ACP) SystemMeditech Spine, LLC20163
K101848Sapphire Anterior Cervical Plate SystemSpinal Elements, Inc.20102
K191786Cyclops™ Anterior Cervical Plate SystemDegen Medical, Inc.20191

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 · 6 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall

What does this lineage say?

  • Of its descendants, K971883 (Synthes (Usa), 1997) has gone furthest, with 531 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 Synthes (Usa)

406 FDA decisions under this applicant name. See the company

  • K131984Synthes Synsonic Ulna NailSynthes (Usa) · 2014
  • K111667Synthes Suprapatellar Insertion InstrumentsSynthes (Usa) · 20111 recall
  • K111540Synthes 3.5MM LCP Clavicle Plate SystemSynthes (Usa) · 2011
  • K110789Synthes Sternal Zipfix SystemSynthes (Usa) · 20113 recalls
  • K103002Synthes Multiloc Proximal Humeral Nailing SystemSynthes (Usa) · 20112 recalls

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/K926453 · printed Nov 6, 2026

Cite this page

510(k) Report. “K926453: Synthes (U.S.a.) Anterior Cervical Vertebrae Plate.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K926453

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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