510(k) Report

510(k) · Cleared

Cleared

Anodyne Anterior Cervical Plate System

K132994510(k) TraditionalCleared Dec 5, 201372-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 5, 2013 as substantially equivalent to K121514 (Corelink, LLC, 2012) and 4 other predicates after a 72-day review. Its family tree reaches back 5 generations to 1997. 1 later device descends from it.

Decided
Dec 5, 2013
Review
72 days
Class
Class II
Product code
KWQ
Recalls
None
Predicates
5

Its longest line of descent runs back 5 generations to K971730 (1997). 20 ancestors in all, the oldest K914362 (1992). 1 later device descends from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2004: 2 other ancestors2000: 2 other ancestors2001: 1 other ancestor1999: 1 other ancestor1998: 2 other ancestors1992: 1 other ancestor1997: 3 other ancestors1995: 1 other ancestor1993: 2 other ancestors2023: 1 descendant 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. · 2010K121514 · Anodyne Anterior Cervical Plate System · Corelink, LLC · 20121990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors2 generations back: 6 other ancestors3 generations back: 4 other ancestors4 generations back: 3 other ancestors 1 generation forward: 1 descendant K121514 · Anodyne Anterior Cervical Plate System · Corelink, LLC · 2012K100070 · 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. · 1997−50
  1. Root · 5 generations backK971730 Depuy Motech Peak Polyaxial Anterior Cervical Plate SystemDepuy, Inc. · 1997
  2. 4 generations backK040197 Eagle Anterior Cervial Plate SystemDepuyacromed · 2004
  3. 3 generations backK082273 Uniplate Anterior Cervical Plate SystemDepuy Spine, Inc. · 2008
  4. 2 generations backK100070 Uniplate Anterior Cervical Plate SystemDepuy Spine, Inc. · 2010
  5. 1 generation backK121514 Anodyne Anterior Cervical Plate SystemCorelink, LLC · 2012
  6. This deviceK132994 Anodyne Anterior Cervical Plate SystemCorelink, LLC · 2013
  7. Descendant · cites it directly · 0 of its ownK231145 Axis Anterior Cervical Plate SystemSouthern Medical (Pty), Ltd. · 2023

Most influential descendants

Showing 1 of 1 · See all
  • K231145Axis Anterior Cervical Plate SystemSouthern Medical (Pty), Ltd. · 2023 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−5K971730Depuy Motech Peak Polyaxial Anterior Cervical Plate SystemDepuy, Inc.1997—
−4K040197Eagle Anterior Cervial Plate SystemDepuyacromed2004—
−3K082273Uniplate Anterior Cervical Plate SystemDepuy Spine, Inc.2008—
−2K100070Uniplate Anterior Cervical Plate SystemDepuy Spine, Inc.2010—
−1K121514Anodyne Anterior Cervical Plate SystemCorelink, LLC2012—
0 (this device)K132994Anodyne Anterior Cervical Plate SystemCorelink, LLC2013—
+1K231145Axis Anterior Cervical Plate SystemSouthern Medical (Pty), Ltd.2023—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199210
199320
199510
199730
199820
199910
200020
200110
200420

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202310
FIG. 1 — Lineage of K132994, 1997–2023Source: 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? (5)

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
*K121514Anodyne Anterior Cervical Plate System
Summary page 1
…CIFR section: 21 CFR section 888.3060 Device panel: Orthopedic Anodyne Tm Anterior Cervical Plate System (K121514) Legally Marketed UNIPLATE Anterior Cervical Plate System (K(042544/ K082273K1 00070) Predicate Devic…
Corelink, LLC2012—
*K042544Uniplate Anterior Cervical Plate System
Summary page 1
…Orthopedic Anodyne Tm Anterior Cervical Plate System (K121514) Legally Marketed UNIPLATE Anterior Cervical Plate System (K(042544/ K082273K1 00070) Predicate Device: CSLP Anterior Cervical Plate (Synthes - K000536) Submitter…
Depuy Spine, Inc.2004—
*K082273Uniplate Anterior Cervical Plate System
Summary page 1
…dic Anodyne Tm Anterior Cervical Plate System (K121514) Legally Marketed UNIPLATE Anterior Cervical Plate System (K(042544/ K082273K1 00070) Predicate Device: CSLP Anterior Cervical Plate (Synthes - K000536) Submitter: CoreL-i…
Depuy Spine, Inc.2008—
*K100070Uniplate Anterior Cervical Plate System
Summary page 1
…Anodyne Tm Anterior Cervical Plate System (K121514) Legally Marketed UNIPLATE Anterior Cervical Plate System (K(042544/ K082273K1 00070) Predicate Device: CSLP Anterior Cervical Plate (Synthes - K000536) Submitter: CoreL-ink, LLC…
Depuy Spine, Inc.2010—
*K000536Synthes Anterior CSLP System
Summary page 1
…Legally Marketed UNIPLATE Anterior Cervical Plate System (K(042544/ K082273K1 00070) Predicate Device: CSLP Anterior Cervical Plate (Synthes - K000536) Submitter: CoreL-ink, LLC 7606 Forsyth Blvd…
Synthes Spine20001

Also cleared against K121514: 1 other device →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K231145Axis Anterior Cervical Plate SystemSouthern Medical (Pty), Ltd.20230

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 16 years and passes through 4 companies; a new generation was cleared every 2.9 years on median.
  • 1 of the 20 ancestors has a recall of any class.
  • Of its descendants, K231145 (Southern Medical (Pty), Ltd., 2023) has gone furthest, with 0 descendants of its own.
  • 1 other device also cites its predicate K121514.

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. 2013, 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 CoreL-ink ANODYNETm 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 (DDD 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 - TI.

Indications for use as stated in the FDA summary.

Also cleared against K121514

1 other device cites the same predicate.

  • K163104Terrace™ Anterior Cervical Plate SystemCorelink, LLC · 2017

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/K132994 · printed Nov 6, 2026

Cite this page

510(k) Report. “K132994: 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/K132994

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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