510(k) Report

510(k) · Cleared

Cleared

Abc Cervical Plating System

K000486510(k) TraditionalCleared Apr 14, 200060-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 Apr 14, 2000 as substantially equivalent to K974706 (Aesculap, Inc., 1998) and 5 other predicates after a 60-day review. Its family tree reaches back 2 generations to 1992. 289 later devices descend from it.

Decided
Apr 14, 2000
Review
60 days
Class
Class II
Product code
KWQ
Recalls
None
Predicates
6

Its longest line of descent runs back 2 generations to K922087 (1992). 10 ancestors in all. 289 later devices descend from it, 9 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1999: 3 other ancestors1998: 3 other ancestors1995: 1 other ancestor1993: 1 other ancestor2010: 4 descendants cleared2005: 5 descendants cleared2002: 3 descendants cleared2012: 5 descendants cleared2003: 2 descendants cleared2004: 3 descendants cleared2014: 6 descendants cleared2020: 24 descendants cleared2013: 6 descendants cleared2016: 4 descendants cleared2022: 25 descendants cleared2007: 1 descendant cleared2008: 5 descendants cleared2009: 2 descendants cleared2015: 2 descendants cleared2019: 16 descendants cleared2021: 17 descendants cleared2017: 8 descendants cleared2011: 1 descendant cleared2018: 7 descendants cleared2024: 35 descendants cleared2023: 32 descendants cleared2025: 39 descendants cleared2006: 1 descendant cleared2026: 36 descendants clearedK922087 · Anterior Cervical Plate System · Sofamor Danek Mfg., Inc. · 1992K990005 · Spinal Concepts, Inc. (Sci) Anterior Cervical Plate System · Spinal Concepts, Inc. · 1999 · recalled1990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 5 other ancestors2 generations back: 3 other ancestors 1 generation forward: 9 descendants2 generations forward: 24 descendants3 generations forward: 39 descendants4 generations forward: 35 descendants5 generations forward: 33 descendants6 generations forward: 54 descendants7 generations forward: 49 descendants8 generations forward: 28 descendants9 generations forward: 12 descendants10 generations forward: 5 descendants11 generations forward: 1 descendant K990005 · Spinal Concepts, Inc. (Sci) Anterior Cervical Plate System · Spinal Concepts, Inc. · 1999 · recalledK922087 · Anterior Cervical Plate System · Sofamor Danek Mfg., Inc. · 19920+5+10
  1. Root · 2 generations backK922087 Anterior Cervical Plate SystemSofamor Danek Mfg., Inc. · 1992
  2. 1 generation backK990005 Spinal Concepts, Inc. (Sci) Anterior Cervical Plate SystemSpinal Concepts, Inc. · 1999 · Recalled
  3. This deviceK000486 Abc Cervical Plating SystemAesculap, Inc. · 2000
  4. Descendant · cites it directly · 145 of its ownK050813 Abc 2 ScrewAesculap, Inc. · 2005
  5. Descendant · 2 generations on · 132 of its ownK133475 Struxxure Anterior Cervical Plate and ScrewsNexxt Spine, LLC · 2013
  6. Descendant · 3 generations on · 106 of its ownK141376 Inertia Pedicle Screw System, Honour Spacer System, Facet Fixx…Nexxt Spine, LLC · 2014
  7. Descendant · cites it directly · 101 of its ownK122910 Archon Anterior Cervical Plate Syste,Nu Vasive, Incorporated · 2012
  8. Descendant · 4 generations on · 100 of its ownK181435 ATEC Cervical Spacer SystemAlphatec Spine, Inc. · 2018

Showing 5 of 289 descendants. See all descendants

Descendants cleared per year

2002: 32003: 22004: 32005: 52006: 12007: 12008: 52009: 22010: 42011: 12012: 52013: 62014: 62015: 22016: 42017: 82018: 72019: 162020: 242021: 172022: 252023: 322024: 352025: 392026: 36
2002high 39 (2025) · low 1 (2006)2026

Most influential descendants

Showing 5 of 289 · See all
  • K050813Abc 2 ScrewAesculap, Inc. · 2005 · cites it directly145descendants
  • K133475Struxxure Anterior Cervical Plate and ScrewsNexxt Spine, LLC · 2013 · 2 generations on132descendants
  • K141376Inertia Pedicle Screw System, Honour Spacer System, Facet Fixx, Struxxure Anterior…Nexxt Spine, LLC · 2014 · 3 generations on106descendants
  • K122910Archon Anterior Cervical Plate Syste,Nu Vasive, Incorporated · 2012 · cites it directly101descendants
  • K181435ATEC Cervical Spacer SystemAlphatec Spine, Inc. · 2018 · 4 generations on100descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K922087Anterior Cervical Plate SystemSofamor Danek Mfg., Inc.1992—
−1K990005Spinal Concepts, Inc. (Sci) Anterior Cervical Plate SystemSpinal Concepts, Inc.19991
0 (this device)K000486Abc Cervical Plating SystemAesculap, Inc.2000—
+1K050813Abc 2 ScrewAesculap, Inc.2005—
+2K133475Struxxure Anterior Cervical Plate and ScrewsNexxt Spine, LLC2013—
+3K141376Inertia Pedicle Screw System, Honour Spacer System, Facet Fixx, Struxxure…Nexxt Spine, LLC2014—
+1K122910Archon Anterior Cervical Plate Syste,Nu Vasive, Incorporated2012—
+4K181435ATEC Cervical Spacer SystemAlphatec Spine, Inc.2018—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199310
199510
199830
199930

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200230
200320
200430
200550
200610
200710
200850
200920
201040
201110
201250
201360
201460
201520
201640
201780
201870
2019160
2020240
2021170
2022250
2023320
2024350
2025390
2026360
FIG. 1 — Lineage of K000486, 1992–2026Source: 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? (6)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*K974706Aesculap Abc Cervical Plating System
Summary page 2
…VALENCE The new and modified components described in this premarket notification are substantially equivalent to those in Aesculap's current ABC Cervical Plating System (K974706) with regard to intended use, fundamental scientific technology, design, and material. In addition, the following predicate anter…
Aesculap, Inc.1998—
*K990005Spinal Concepts, Inc. (Sci) Anterior Cervical Plate System
Summary page 2
…ervical plating systems recently received FDA clearance for similar device modifications and system expansions: AcuFikTmAnterior Cervical Plate System (K990005) ATLANTISTmAnterior Cervical Plate System (K993855) BlackstoneT" Anterior Cervical Plate Sys…
Spinal Concepts, Inc.19991
*K993855Atlantis Anterior Cervical Plate System
Summary page 2
…evice modifications and system expansions: AcuFikTmAnterior Cervical Plate System (K990005) ATLANTISTmAnterior Cervical Plate System (K993855) BlackstoneT" Anterior Cervical Plate System (K974885) Osteonics ACCP System (K982798, K992…
Danek Medical, Inc.1999—
*K974885Blackstone Medical Inc. Anterior Cervical Plate System
Summary page 2
…rior Cervical Plate System (K990005) ATLANTISTmAnterior Cervical Plate System (K993855) BlackstoneT" Anterior Cervical Plate System (K974885) Osteonics ACCP System (K982798, K992344) These competitor systems are substantially equivalent to the nr)dif…
Blackstone Medical, Inc.1998—
*K982798Osteonics Anterior Cervical Compression Plating System
Summary page 2
…ATLANTISTmAnterior Cervical Plate System (K993855) BlackstoneT" Anterior Cervical Plate System (K974885) Osteonics ACCP System (K982798, K992344) These competitor systems are substantially equivalent to the nr)dified ABC Cervical Plating System with regard to inte…
Osteonics Corp.1999—
*K992344Osteonics Accp System Line Extension
Summary page 2
…TISTmAnterior Cervical Plate System (K993855) BlackstoneT" Anterior Cervical Plate System (K974885) Osteonics ACCP System (K982798, K992344) These competitor systems are substantially equivalent to the nr)dified ABC Cervical Plating System with regard to intended use,…
Howmedica Osteonics Corp.1999—

Also cleared against K974706: 8 other devices →

What descends from it? (289)

See all 289

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

NumberDeviceApplicantDecidedDescendants
K050813Abc 2 ScrewAesculap, Inc.2005145
K122910Archon Anterior Cervical Plate Syste,Nu Vasive, Incorporated2012101
K012184Blackstone Iii Anterior Cervical Plating SystemBlackstone Medical, Inc.200285
K030595Blackstone Fusion Anterior Cervical Plating SystemBlackstone Medical, Inc.200366
K043066Pioneer Anterior Cervical Plate SystemPioneer Surgical Technology200527
K040017Abc Caudal and Cranial Extension Plate (E-Plate)Aesculap, Inc.200413
K100243Quintex Cervical Plating SystemAesculap Implant Systems, LLC201010
K112809Blue Mountain Cervical PlateQualgenix, LLC20122
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?

  • The line of descent spans 8 years and passes through 3 companies; a new generation was cleared every 6.3 years on median.
  • 1 of the 10 ancestors has a recall of any class.
  • Of its descendants, K050813 (Aesculap, Inc., 2005) has gone furthest, with 145 descendants of its own.
  • 8 other devices also cite its predicate K974706.

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 discogenic pain with degeneration 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. Levels of anterior cervical intervertebral body screw fixation for this indication are from C2-T1.

WARNING: This device is not approved for screw attachment to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.

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

Also cleared against K974706

8 other devices cite the same predicate.

  • K190666CYGNUS™ Anterior Cervical Plate SystemMiRus, LLC · 2019
  • K173099Fortis and Hana Anterior Cervical Plate SystemHuvexel Co., Ltd. · 2017
  • K140361Meta-C Cervical PlateMedacta International · 2014
  • K112809Blue Mountain Cervical PlateQualgenix, LLC · 2012
  • K100243Quintex Cervical Plating SystemAesculap Implant Systems, LLC · 20101 recall
  • K090861Mambo, Model CS 18XX-XXUlrich GmbH & Co. KG · 2010

More from Aesculap, Inc.

208 FDA decisions under this applicant name. See the company

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  • 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/K000486 · printed Nov 6, 2026

Cite this page

510(k) Report. “K000486: 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/K000486

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026