510(k) Report

510(k) · Cleared

Recalled · Class II · 2015

C-Tek Maxan Anterior Cervical Plate System

K080646510(k) TraditionalCleared May 2, 200857-day reviewClass II21 CFR 888.3060Recalls 2

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Biomet Spine · KWQ Appliance, Fixation, Spinal Intervertebral Body

Cleared on May 2, 2008 as substantially equivalent to K060379 (Ebi, L.P., 2006) and 4 other predicates after a 57-day review. Its family tree reaches back 4 generations to 1995. 193 later devices descend from it. It has been recalled 2 times.

Decided
May 2, 2008
Review
57 days
Class
Class II
Product code
KWQ
Recalls
2
Predicates
5

Its longest line of descent runs back 4 generations to K953730 (1995). 8 ancestors in all. 193 later devices descend from it, 11 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2007: 1 other ancestor2006: 1 other ancestor2004: 1 other ancestor1997: 1 other ancestor2021: 12 descendants cleared2016: 7 descendants cleared2025: 29 descendants cleared2019: 12 descendants cleared2008: 1 descendant cleared2013: 4 descendants cleared2015: 5 descendants cleared2014: 6 descendants cleared2024: 26 descendants cleared2017: 4 descendants cleared2020: 18 descendants cleared2023: 25 descendants cleared2018: 2 descendants cleared2022: 16 descendants cleared2026: 26 descendants clearedK953730 · Codman Anterior Cervical Plate System · Johnson & Johnson Professionals, Inc. · 1995K013877 · Codman Slim-Loc System · Codman & Shurtleff, Inc. · 2001K040655 · Swift Anterior Cervical Plate System · Depuy Spine, Inc. · 2004K072546 · Swift Plus Anterior Cervical Plate System · Depuy Spine, Inc. · 20071995200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 3 other ancestors2 generations back: 1 other ancestor 1 generation forward: 11 descendants2 generations forward: 25 descendants3 generations forward: 28 descendants4 generations forward: 21 descendants5 generations forward: 33 descendants6 generations forward: 33 descendants7 generations forward: 23 descendants8 generations forward: 14 descendants9 generations forward: 4 descendants10 generations forward: 1 descendant K072546 · Swift Plus Anterior Cervical Plate System · Depuy Spine, Inc. · 2007K040655 · Swift Anterior Cervical Plate System · Depuy Spine, Inc. · 2004K013877 · Codman Slim-Loc System · Codman & Shurtleff, Inc. · 2001K953730 · Codman Anterior Cervical Plate System · Johnson & Johnson Professionals, Inc. · 19950+5+10
  1. Root · 4 generations backK953730 Codman Anterior Cervical Plate SystemJohnson & Johnson Professionals, Inc. · 1995
  2. 3 generations backK013877 Codman Slim-Loc SystemCodman & Shurtleff, Inc. · 2001
  3. 2 generations backK040655 Swift Anterior Cervical Plate SystemDepuy Spine, Inc. · 2004
  4. 1 generation backK072546 Swift Plus Anterior Cervical Plate SystemDepuy Spine, Inc. · 2007
  5. This deviceK080646 C-Tek Maxan Anterior Cervical Plate SystemBiomet Spine · 2008
  6. Descendant · cites it directly · 132 of its ownK133475 Struxxure Anterior Cervical Plate and ScrewsNexxt Spine, LLC · 2013
  7. Descendant · 2 generations on · 106 of its ownK141376 Inertia Pedicle Screw System, Honour Spacer System, Facet Fixx…Nexxt Spine, LLC · 2014
  8. Descendant · 3 generations on · 100 of its ownK181435 ATEC Cervical Spacer SystemAlphatec Spine, Inc. · 2018
  9. Descendant · 4 generations on · 99 of its ownK183705 IdentiTi Porous Ti Interbody SystemAlphatec Spine, Inc. · 2019
  10. Descendant · 5 generations on · 78 of its ownK191311 ATEC Lateral Interbody SystemAlphatec Spine, Inc. · 2019

Showing 5 of 193 descendants. See all descendants

Descendants cleared per year

2008: 12013: 42014: 62015: 52016: 72017: 42018: 22019: 122020: 182021: 122022: 162023: 252024: 262025: 292026: 26
2008high 29 (2025) · low 0 (2009)2026

Most influential descendants

Showing 5 of 193 · See all
  • K133475Struxxure Anterior Cervical Plate and ScrewsNexxt Spine, LLC · 2013 · cites it directly132descendants
  • K141376Inertia Pedicle Screw System, Honour Spacer System, Facet Fixx, Struxxure Anterior…Nexxt Spine, LLC · 2014 · 2 generations on106descendants
  • K181435ATEC Cervical Spacer SystemAlphatec Spine, Inc. · 2018 · 3 generations on100descendants
  • K183705IdentiTi Porous Ti Interbody SystemAlphatec Spine, Inc. · 2019 · 4 generations on99descendants
  • K191311ATEC Lateral Interbody SystemAlphatec Spine, Inc. · 2019 · 5 generations on78descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K953730Codman Anterior Cervical Plate SystemJohnson & Johnson Professionals, Inc.1995—
−3K013877Codman Slim-Loc SystemCodman & Shurtleff, Inc.2001—
−2K040655Swift Anterior Cervical Plate SystemDepuy Spine, Inc.2004—
−1K072546Swift Plus Anterior Cervical Plate SystemDepuy Spine, Inc.2007—
0 (this device)K080646C-Tek Maxan Anterior Cervical Plate SystemBiomet Spine2008—
+1K133475Struxxure Anterior Cervical Plate and ScrewsNexxt Spine, LLC2013—
+2K141376Inertia Pedicle Screw System, Honour Spacer System, Facet Fixx, Struxxure…Nexxt Spine, LLC2014—
+3K181435ATEC Cervical Spacer SystemAlphatec Spine, Inc.2018—
+4K183705IdentiTi Porous Ti Interbody SystemAlphatec Spine, Inc.2019—
+5K191311ATEC Lateral Interbody SystemAlphatec Spine, Inc.2019—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199710
200410
200610
200710

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200810
201340
201460
201550
201670
201740
201820
2019120
2020180
2021120
2022160
2023250
2024260
2025290
2026260
FIG. 1 — Lineage of K080646, 1995–2026Source: 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? (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
*K060379Ebi Anterior Cervical Plate System
Summary page 1
…lass II, 21 CFR §888.3060, KWQ Predicate Device(s): EBI Anterior Cervical Plate System (Cyprus Anterior Cervical Plating System), K060379 EAGLE+ Anterior Cervical Plate system, K070994, K040 197 Swift Plus A…
Ebi, L.P.2006—
*K070994Eagle + Anterior Cervical Plate System
Summary page 1
…rvical Plate System (Cyprus Anterior Cervical Plating System), K060379 EAGLE+ Anterior Cervical Plate system, K070994, K040 197 Swift Plus Anterior Cervical Plate System, K072546, K040655 Device Description:…
Depuy Spine, Inc.2007—
*K040197Eagle Anterior Cervial Plate System
Summary page 1
…ate System (Cyprus Anterior Cervical Plating System), K060379 EAGLE+ Anterior Cervical Plate system, K070994, K040 197 Swift Plus Anterior Cervical Plate System, K072546, K040655 Device Description: The C-Te…
Depuyacromed2004—
*K072546Swift Plus Anterior Cervical Plate System
Summary page 1
…, K060379 EAGLE+ Anterior Cervical Plate system, K070994, K040 197 Swift Plus Anterior Cervical Plate System, K072546, K040655 Device Description: The C-Tek® MaxAnTM Anterior Cervical Plate System consists of…
Depuy Spine, Inc.2007—
*K040655Swift Anterior Cervical Plate System
Summary page 1
…EAGLE+ Anterior Cervical Plate system, K070994, K040 197 Swift Plus Anterior Cervical Plate System, K072546, K040655 Device Description: The C-Tek® MaxAnTM Anterior Cervical Plate System consists of titani…
Depuy Spine, Inc.2004—

Also cleared against K060379: 3 other devices →

What descends from it? (193)

See all 193

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

NumberDeviceApplicantDecidedDescendants
K133475Struxxure Anterior Cervical Plate and ScrewsNexxt Spine, LLC2013132
K081038Atlantis Anterior Cervical Plate SystemMedtronic Sofamor Danek200835
K133518Maxan Anterior Cervical Plate SystemBiomet Spine (Aka Ebi, LLC)201425
K151553Anterior Cervical Plate SystemOsteomed Implantes, Ltda201611
K160702ZION Anterior Cervical Fixation SystemAstura Medical20163
K150666uNion Cervical Plate SystemUlrich Medical USA20153
K191786Cyclops™ Anterior Cervical Plate SystemDegen Medical, Inc.20191
K250446Frida™ Anterior Cervical Plate SystemSpineup, Inc.20250
K213456Xenco Medical Multilevel CerviKitXenco Medical, LLC20210
K192494NexGen Anterior Cervical Plate SystemPrecision Spine20190

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Sep 29, 2015Class IIZ-0203-2016Labeling mix-upsThe packaging of 4.5 mm diameter MaxAn screws identifies/labels the screws as 4.0 mm diameter screws.
Aug 5, 2015Class IIZ-2744-2015Labeling mix-upsSome of P/N 14-521614B Lot 375440 was mislabeled as P/N 14-521614 Lot 375440.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 13 years and passes through 4 companies; a new generation was cleared every 3.3 years on median.
  • None of the 8 ancestors has a recall.
  • Of its descendants, K133475 (Nexxt Spine, LLC, 2013) has gone furthest, with 132 descendants of its own.
  • 3 other devices also cite its predicate K060379.

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. 2008, 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 C-Tek® MaxAnTM Anterior Cervical Plate System is intended for anterior interbody fixation of the cervical spine. Indications for use include the temporary stabilization of the anterior spine during the development of cervical fusions in patients with degenerative disc disease (as defined by neck pain of discogenic origin confirmed by patient history and radiographic studies), trauma including fractures, tumors, deformity (defined as 'kyphosis, lordosis, or scoliosis), pseudarthroses, and/or failed previous fusions. The intended levels for treatment range from C2 - T1.

Indications for use as stated in the FDA summary.

Also cleared against K060379

3 other devices cite the same predicate.

  • K150983Pyrenees Cervical Plate SystemK2m · 2015
  • K092474Pyrenees Cervical Plate System, Semi-Constrained ScrewsK2m, Inc. · 2010
  • K071325Biomet Variable Locking Plate SystemBiomet Trauma · 2007

More from Biomet Spine

19 FDA decisions under this applicant name. See the company

  • K152622Alta ACDF SystemBiomet Spine · 2016
  • K151974Polaris Spinal SystemBiomet Spine · 2015
  • K151064Solitaire-C Cervical Spacer System, C-Thru Anterior Spinal System, Breckenridge Small Intervertebral Body…Biomet Spine · 2015
  • K151224Lineum OCT Spine SystemBiomet Spine · 20151 recall
  • K141791Biomet Fusion SystemBiomet Spine · 2014

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/K080646 · printed Nov 3, 2026

Cite this page

510(k) Report. “K080646: C-Tek Maxan Anterior Cervical Plate System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K080646

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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