510(k) Report

510(k) · Cleared

Cleared

Aesculap Abc Cervical Plating System

K974706510(k) TraditionalCleared Mar 13, 199887-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

Aesculap, Inc. · KWQ Appliance, Fixation, Spinal Intervertebral Body

Cleared on Mar 13, 1998 after an 87-day review. The FDA summary names no predicate by number. 299 later devices descend from it.

Decided
Mar 13, 1998
Review
87 days
Class
Class II
Product code
KWQ
Recalls
None
Predicates
0

299 later devices descend from it, 9 citing it directly.

Descendants, by year cleared 2010: 4 descendants cleared2017: 9 descendants cleared2019: 17 descendants cleared2012: 5 descendants cleared2000: 1 descendant cleared2005: 5 descendants cleared2014: 7 descendants cleared2004: 3 descendants cleared2002: 3 descendants cleared2003: 2 descendants cleared2007: 1 descendant cleared2013: 6 descendants cleared2008: 5 descendants cleared2006: 1 descendant cleared2015: 2 descendants cleared2022: 28 descendants cleared2020: 24 descendants cleared2016: 4 descendants cleared2009: 2 descendants cleared2018: 7 descendants cleared2021: 17 descendants cleared2023: 33 descendants cleared2024: 36 descendants cleared2025: 40 descendants cleared2011: 1 descendant cleared2026: 36 descendants cleared1995200020052010201520202025
  1. This deviceK974706 Aesculap Abc Cervical Plating SystemAesculap, Inc. · 1998
  2. Descendant · cites it directly · 289 of its ownK000486 Abc Cervical Plating SystemAesculap, Inc. · 2000
  3. Descendant · 2 generations on · 145 of its ownK050813 Abc 2 ScrewAesculap, Inc. · 2005
  4. Descendant · 3 generations on · 132 of its ownK133475 Struxxure Anterior Cervical Plate and ScrewsNexxt Spine, LLC · 2013
  5. Descendant · 4 generations on · 106 of its ownK141376 Inertia Pedicle Screw System, Honour Spacer System, Facet Fixx…Nexxt Spine, LLC · 2014
  6. Descendant · 2 generations on · 101 of its ownK122910 Archon Anterior Cervical Plate Syste,Nu Vasive, Incorporated · 2012

Showing 5 of 299 descendants. See all descendants

Descendants cleared per year

2000: 12002: 32003: 22004: 32005: 52006: 12007: 12008: 52009: 22010: 42011: 12012: 52013: 62014: 72015: 22016: 42017: 92018: 72019: 172020: 242021: 172022: 282023: 332024: 362025: 402026: 36
2000high 40 (2025) · low 0 (2001)2026

Most influential descendants

Showing 5 of 299 · See all
  • K000486Abc Cervical Plating SystemAesculap, Inc. · 2000 · cites it directly289descendants
  • K050813Abc 2 ScrewAesculap, Inc. · 2005 · 2 generations on145descendants
  • K133475Struxxure Anterior Cervical Plate and ScrewsNexxt Spine, LLC · 2013 · 3 generations on132descendants
  • K141376Inertia Pedicle Screw System, Honour Spacer System, Facet Fixx, Struxxure Anterior…Nexxt Spine, LLC · 2014 · 4 generations on106descendants
  • K122910Archon Anterior Cervical Plate Syste,Nu Vasive, Incorporated · 2012 · 2 generations on101descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K974706Aesculap Abc Cervical Plating SystemAesculap, Inc.1998—
+1K000486Abc Cervical Plating SystemAesculap, Inc.2000—
+2K050813Abc 2 ScrewAesculap, Inc.2005—
+3K133475Struxxure Anterior Cervical Plate and ScrewsNexxt Spine, LLC2013—
+4K141376Inertia Pedicle Screw System, Honour Spacer System, Facet Fixx, Struxxure…Nexxt Spine, LLC2014—
+2K122910Archon Anterior Cervical Plate Syste,Nu Vasive, Incorporated2012—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200010
200230
200320
200430
200550
200610
200710
200850
200920
201040
201110
201250
201360
201470
201520
201640
201790
201870
2019170
2020240
2021170
2022280
2023330
2024360
2025400
2026360
FIG. 1 — Lineage of K974706, 1998–2026Source: 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), the FDA summary (predicates and indications), 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
Get a 510(k) Report

What was it cleared against?

The FDA summary names no predicate by number.

What descends from it? (299)

See all 299

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

NumberDeviceApplicantDecidedDescendants
K000486Abc Cervical Plating SystemAesculap, Inc.2000289
K040017Abc Caudal and Cranial Extension Plate (E-Plate)Aesculap, Inc.200413
K100243Quintex Cervical Plating SystemAesculap Implant Systems, LLC201010
K051815Modification to Vertebron SCP Cervical Plate SystemVertebron, Inc.200510
K173099Fortis and Hana Anterior Cervical Plate SystemHuvexel Co., Ltd.20174
K190666CYGNUS™ Anterior Cervical Plate SystemMiRus, LLC20192
K112809Blue Mountain Cervical PlateQualgenix, LLC20122
K140361Meta-C Cervical PlateMedacta International20140
K090861Mambo, Model CS 18XX-XXUlrich GmbH & Co. KG20100

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, K000486 (Aesculap, Inc., 2000) has gone furthest, with 289 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—

What is it indicated for?

The ABC Cervical Plating System is intended for the treatment of cervical spine instability resulting from degenerative disc disease (defined as discongenic pain with generation of the disc confirmed by history and radiographic studies), trauma (including fractures), post-traumatic kyphosis or lordosis, tumors, and re-operation for failed previous fusions through anterior cervical intervertebral body screw fixation. Levels of screw fixation for this indication are from C, to T,.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

More from Aesculap, Inc.

208 FDA decisions under this applicant name. See the company

  • K260044Ventricular Catheters, Thomale CatheterAesculap, Inc. · 2026
  • K242762Aesculap Aicon® Series Container SystemAesculap, Inc. · 2025
  • K242003XABO Ventricular Catheter, XABO Peritoneal Catheter, XABO Catheter SetAesculap, Inc. · 2024
  • K223596SQ.line KERRISONAesculap, Inc. · 2023
  • K214041Aesculap AICON ContainerAesculap, Inc. · 2022

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/K974706 · printed Nov 6, 2026

Cite this page

510(k) Report. “K974706: Aesculap Abc Cervical Plating System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K974706

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026