510(k) Report

510(k) · Cleared

Cleared

Anodyne Anterior Cervical Plate System

K121514510(k) TraditionalCleared Dec 14, 2012206-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

Corelink, LLC · KWQ Appliance, Fixation, Spinal Intervertebral Body

Cleared on Dec 14, 2012 as substantially equivalent to K993855 (Danek Medical, Inc., 1999) and 7 other predicates after a 206-day review. Its family tree reaches back 4 generations to 1997. 21 later devices descend from it.

Decided
Dec 14, 2012
Review
206 days
Class
Class II
Product code
KWQ
Recalls
None
Predicates
8

Its longest line of descent runs back 4 generations to K971730 (1997). 18 ancestors in all, the oldest K914362 (1992). 21 later devices descend from it, 2 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2004: 2 other ancestors2001: 1 other ancestor2000: 1 other ancestor1999: 1 other ancestor1998: 2 other ancestors1997: 3 other ancestors1992: 1 other ancestor1995: 1 other ancestor1993: 2 other ancestors2017: 1 descendant cleared2013: 1 descendant cleared2023: 5 descendants cleared2019: 1 descendant cleared2020: 2 descendants cleared2021: 1 descendant cleared2022: 1 descendant cleared2025: 3 descendants cleared2024: 4 descendants cleared2026: 2 descendants clearedK971730 · Depuy Motech Peak Polyaxial Anterior Cervical Plate System · Depuy, Inc. · 1997K040197 · Eagle Anterior Cervial Plate System · Depuyacromed · 2004K082273 · Uniplate Anterior Cervical Plate System · Depuy Spine, Inc. · 2008K100070 · Uniplate Anterior Cervical Plate System · Depuy Spine, Inc. · 20101990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 6 other ancestors2 generations back: 5 other ancestors3 generations back: 3 other ancestors 1 generation forward: 2 descendants2 generations forward: 4 descendants3 generations forward: 3 descendants4 generations forward: 8 descendants5 generations forward: 3 descendants6 generations forward: 1 descendant K100070 · Uniplate Anterior Cervical Plate System · Depuy Spine, Inc. · 2010K082273 · Uniplate Anterior Cervical Plate System · Depuy Spine, Inc. · 2008K040197 · Eagle Anterior Cervial Plate System · Depuyacromed · 2004K971730 · Depuy Motech Peak Polyaxial Anterior Cervical Plate System · Depuy, Inc. · 19970+5
  1. Root · 4 generations backK971730 Depuy Motech Peak Polyaxial Anterior Cervical Plate SystemDepuy, Inc. · 1997
  2. 3 generations backK040197 Eagle Anterior Cervial Plate SystemDepuyacromed · 2004
  3. 2 generations backK082273 Uniplate Anterior Cervical Plate SystemDepuy Spine, Inc. · 2008
  4. 1 generation backK100070 Uniplate Anterior Cervical Plate SystemDepuy Spine, Inc. · 2010
  5. This deviceK121514 Anodyne Anterior Cervical Plate SystemCorelink, LLC · 2012
  6. Descendant · cites it directly · 18 of its ownK163104 Terrace™ Anterior Cervical Plate SystemCorelink, LLC · 2017
  7. Descendant · 2 generations on · 15 of its ownK190016 Lateral Plate SystemCorelink, LLC · 2019
  8. Descendant · 3 generations on · 9 of its ownK203065 Lumbar Spine Truss System Plating Solution (LSTS-PS)4Web, Inc. · 2021
  9. Descendant · 3 generations on · 3 of its ownK231743 F3D Lateral Lumbar Interbody System, CL5 Lateral Lumbar Interbody…Corelink, LLC · 2023
  10. Descendant · 4 generations on · 3 of its ownK223362 Cervical Spine Truss System - Stand Alone (CSTS-SA) Interbody Fusion…4Web Medical, Inc. · 2023

Showing 5 of 21 descendants. See all descendants

Descendants cleared per year

2013: 12017: 12019: 12020: 22021: 12022: 12023: 52024: 42025: 32026: 2
2013high 5 (2023) · low 0 (2014)2026

Most influential descendants

Showing 5 of 21 · See all
  • K163104Terrace™ Anterior Cervical Plate SystemCorelink, LLC · 2017 · cites it directly18descendants
  • K190016Lateral Plate SystemCorelink, LLC · 2019 · 2 generations on15descendants
  • K203065Lumbar Spine Truss System Plating Solution (LSTS-PS)4Web, Inc. · 2021 · 3 generations on9descendants
  • K231743F3D Lateral Lumbar Interbody System, CL5 Lateral Lumbar Interbody System, and Oro…Corelink, LLC · 2023 · 3 generations on3descendants
  • K223362Cervical Spine Truss System - Stand Alone (CSTS-SA) Interbody Fusion Device4Web Medical, Inc. · 2023 · 4 generations on3descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K971730Depuy Motech Peak Polyaxial Anterior Cervical Plate SystemDepuy, Inc.1997—
−3K040197Eagle Anterior Cervial Plate SystemDepuyacromed2004—
−2K082273Uniplate Anterior Cervical Plate SystemDepuy Spine, Inc.2008—
−1K100070Uniplate Anterior Cervical Plate SystemDepuy Spine, Inc.2010—
0 (this device)K121514Anodyne Anterior Cervical Plate SystemCorelink, LLC2012—
+1K163104Terrace™ Anterior Cervical Plate SystemCorelink, LLC2017—
+2K190016Lateral Plate SystemCorelink, LLC2019—
+3K203065Lumbar Spine Truss System Plating Solution (LSTS-PS)4Web, Inc.2021—
+3K231743F3D Lateral Lumbar Interbody System, CL5 Lateral Lumbar Interbody System, and…Corelink, LLC2023—
+4K223362Cervical Spine Truss System - Stand Alone (CSTS-SA) Interbody Fusion Device4Web Medical, Inc.2023—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199210
199320
199510
199730
199820
199910
200010
200110
200420

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201310
201710
201910
202020
202110
202210
202350
202440
202530
202620
FIG. 1 — Lineage of K121514, 1997–2026Source: 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? (8)

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
*K993855Atlantis Anterior Cervical Plate System
Summary page 2
…tially equivalent to previously cleared devices and has the same indications for use, design, function, and materials used, These devices include the Medtronic Atlantis (K993855), Medtronic Orion (K042235), Synthes Anterior CSLP System (K000742), Theken Tether (K010466), Depuy DOC (K982443), and DePuy Unip…
Danek Medical, Inc.1999—
*K042235Orion Anterior Cervical Plating System
Summary page 2
…usly cleared devices and has the same indications for use, design, function, and materials used, These devices include the Medtronic Atlantis (K993855), Medtronic Orion (K042235), Synthes Anterior CSLP System (K000742), Theken Tether (K010466), Depuy DOC (K982443), and DePuy Uniplate Anterior Cervical Plat…
Medtronic Sofamor Danek2004—
*K000742Synthes Anterior CSLP System
Summary page 2
…dications for use, design, function, and materials used, These devices include the Medtronic Atlantis (K993855), Medtronic Orion (K042235), Synthes Anterior CSLP System (K000742), Theken Tether (K010466), Depuy DOC (K982443), and DePuy Uniplate Anterior Cervical Plate (K 100070, K082273, and K042544). Per…
Synthes Spine2000—
*K010466Tether Acfs
Summary page 2
…, function, and materials used, These devices include the Medtronic Atlantis (K993855), Medtronic Orion (K042235), Synthes Anterior CSLP System (K000742), Theken Tether (K010466), Depuy DOC (K982443), and DePuy Uniplate Anterior Cervical Plate (K 100070, K082273, and K042544). Performance Standards: Test…
Theken Surgical,Llc2001—
*K982443Doc Ventral Cervical Stabilization System
Summary page 2
…ials used, These devices include the Medtronic Atlantis (K993855), Medtronic Orion (K042235), Synthes Anterior CSLP System (K000742), Theken Tether (K010466), Depuy DOC (K982443), and DePuy Uniplate Anterior Cervical Plate (K 100070, K082273, and K042544). Performance Standards: Testing performed on this…
Depuy Motech Acromed1998—
*K100070Uniplate Anterior Cervical Plate System
Summary page 2
…s (K993855), Medtronic Orion (K042235), Synthes Anterior CSLP System (K000742), Theken Tether (K010466), Depuy DOC (K982443), and DePuy Uniplate Anterior Cervical Plate (K 100070, K082273, and K042544). Performance Standards: Testing performed on this device indicates that the ANODYNE® Anterior Cervical P…
Depuy Spine, Inc.2010—
*K082273Uniplate Anterior Cervical Plate System
Summary page 2
…), Medtronic Orion (K042235), Synthes Anterior CSLP System (K000742), Theken Tether (K010466), Depuy DOC (K982443), and DePuy Uniplate Anterior Cervical Plate (K 100070, K082273, and K042544). Performance Standards: Testing performed on this device indicates that the ANODYNE® Anterior Cervical Plate Syst…
Depuy Spine, Inc.2008—
*K042544Uniplate Anterior Cervical Plate System
Summary page 2
…Orion (K042235), Synthes Anterior CSLP System (K000742), Theken Tether (K010466), Depuy DOC (K982443), and DePuy Uniplate Anterior Cervical Plate (K 100070, K082273, and K042544). Performance Standards: Testing performed on this device indicates that the ANODYNE® Anterior Cervical Plate System is substan…
Depuy Spine, Inc.2004—

Also cleared against K993855: 4 other devices →

What descends from it? (21)

See all 21

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

NumberDeviceApplicantDecidedDescendants
K163104Terrace™ Anterior Cervical Plate SystemCorelink, LLC201718
K132994Anodyne Anterior Cervical Plate SystemCorelink, LLC20131

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 15 years and passes through 4 companies; a new generation was cleared every 4.4 years on median.
  • None of the 18 ancestors has a recall.
  • Of its descendants, K163104 (Corelink, LLC, 2017) has gone furthest, with 18 descendants of its own.
  • 4 other devices also cite its predicate K993855.

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. 2012, this device’s year, is highlighted.

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 CoreLink ANODYNES Anterior Cervical Plate System is intended for anterior fixation of the cervical spine. Indications for use include the temporary stabilization of the anterior spine during the evolution of cervical fusions in patients with degenerative disc disease (ODD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), trauma (including fractures), tumors, deformity (defined as kyphosis, lordosis, or scoliosis), pseudarthrosis, and/or failed previous fusions. The intended levels for treatment range from C2 - T I.

Indications for use as stated in the FDA summary.

Also cleared against K993855

4 other devices cite the same predicate.

  • K112809Blue Mountain Cervical PlateQualgenix, LLC · 2012
  • K050804Modification to: Spectrumtm Cervical Spinal SystemAesculap, Inc. · 2005
  • K040401Lanx Anterior Cervial Plate SystemLanx, LLC · 2004
  • K000486Abc Cervical Plating SystemAesculap, Inc. · 2000

More from Corelink, LLC

35 FDA decisions under this applicant name. See the company

  • K231743F3D Lateral Lumbar Interbody System, CL5 Lateral Lumbar Interbody System, and Oro Lateral Plate SystemCorelink, LLC · 2023
  • K231494CoreLink Robotic Navigation InstrumentsCorelink, LLC · 2023
  • K232116CoreLink Navigation InstrumentsCorelink, LLC · 2023
  • K230329F3D Interbody SystemCorelink, LLC · 2023
  • K230880CoreLink Navigation InstrumentsCorelink, LLC · 2023

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/K121514 · printed Nov 6, 2026

Cite this page

510(k) Report. “K121514: Anodyne Anterior Cervical Plate System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121514

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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