510(k) Report

510(k) · Cleared

Cleared

Maxima Anterior Cervical Plate System

K061002510(k) TraditionalCleared Nov 15, 2006218-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

U&I Corp. · KWQ Appliance, Fixation, Spinal Intervertebral Body

Cleared on Nov 15, 2006 as substantially equivalent to K994239 (Medtronic Sofamor Danek, Inc., 2000) and 1 other predicate after a 218-day review. Its family tree reaches back 1 generation to 2000. 44 later devices descend from it.

Decided
Nov 15, 2006
Review
218 days
Class
Class II
Product code
KWQ
Recalls
None
Predicates
2

Its longest line of descent runs back 1 generation to K994239 (2000). 2 ancestors in all. 44 later devices descend from it, 6 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2003: 1 other ancestor2014: 1 descendant cleared2010: 1 descendant cleared2012: 3 descendants cleared2013: 3 descendants cleared2016: 2 descendants cleared2023: 8 descendants cleared2015: 2 descendants cleared2017: 1 descendant cleared2022: 5 descendants cleared2019: 4 descendants cleared2018: 2 descendants cleared2024: 3 descendants cleared2026: 3 descendants cleared2025: 3 descendants cleared2021: 3 descendants clearedK994239 · Zephir Anterior Cervical Plate System · Medtronic Sofamor Danek, Inc. · 2000200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor 1 generation forward: 6 descendants2 generations forward: 11 descendants3 generations forward: 14 descendants4 generations forward: 4 descendants5 generations forward: 6 descendants6 generations forward: 3 descendants K994239 · Zephir Anterior Cervical Plate System · Medtronic Sofamor Danek, Inc. · 20000+5
  1. Root · 1 generation backK994239 Zephir Anterior Cervical Plate SystemMedtronic Sofamor Danek, Inc. · 2000
  2. This deviceK061002 Maxima Anterior Cervical Plate SystemU&I Corp. · 2006
  3. Descendant · cites it directly · 19 of its ownK113509 Lexus Anterior Cervical Plate SystemL&K BIOMED Co., Ltd. · 2012
  4. Descendant · 2 generations on · 15 of its ownK143271 CastleLoc-P Anterior Cervical Plate SystemL&K BIOMED Co., Ltd. · 2015
  5. Descendant · 3 generations on · 13 of its ownK190425 CastleLoc-P Anterior Cervical Plate SystemL&K BIOMED Co., Ltd. · 2019
  6. Descendant · 4 generations on · 10 of its ownK210035 ZESPIN SI Joint Fusion System, MegaCerfix Posterior Cervical…Aegis Spine · 2021
  7. Descendant · cites it directly · 7 of its ownK131200 Aspiron Acp SystemU&I Corporation · 2013

Showing 5 of 44 descendants. See all descendants

Descendants cleared per year

2010: 12012: 32013: 32014: 12015: 22016: 22017: 12018: 22019: 42021: 32022: 52023: 82024: 32025: 32026: 3
2010high 8 (2023) · low 0 (2011)2026

Most influential descendants

Showing 5 of 44 · See all
  • K113509Lexus Anterior Cervical Plate SystemL&K BIOMED Co., Ltd. · 2012 · cites it directly19descendants
  • K143271CastleLoc-P Anterior Cervical Plate SystemL&K BIOMED Co., Ltd. · 2015 · 2 generations on15descendants
  • K190425CastleLoc-P Anterior Cervical Plate SystemL&K BIOMED Co., Ltd. · 2019 · 3 generations on13descendants
  • K210035ZESPIN SI Joint Fusion System, MegaCerfix Posterior Cervical Fixation System, MegaCerfix…Aegis Spine · 2021 · 4 generations on10descendants
  • K131200Aspiron Acp SystemU&I Corporation · 2013 · cites it directly7descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K994239Zephir Anterior Cervical Plate SystemMedtronic Sofamor Danek, Inc.2000—
0 (this device)K061002Maxima Anterior Cervical Plate SystemU&I Corp.2006—
+1K113509Lexus Anterior Cervical Plate SystemL&K BIOMED Co., Ltd.2012—
+2K143271CastleLoc-P Anterior Cervical Plate SystemL&K BIOMED Co., Ltd.2015—
+3K190425CastleLoc-P Anterior Cervical Plate SystemL&K BIOMED Co., Ltd.2019—
+4K210035ZESPIN SI Joint Fusion System, MegaCerfix Posterior Cervical Fixation System…Aegis Spine2021—
+1K131200Aspiron Acp SystemU&I Corporation2013—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200310

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201010
201230
201330
201410
201520
201620
201710
201820
201940
202130
202250
202380
202430
202530
202630
FIG. 1 — Lineage of K061002, 2000–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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? (2)

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
*K994239Zephir Anterior Cervical Plate System
Summary page 1
…xi MaTm Anterior Cervical Plate System is substantially equivalent in intended use, materials, anatomical site to ZEPHIR Tm Anterior Cervical Plate System (K994239, K030327) Exhibit 4, Page 1 of 2 === Page 2…
Medtronic Sofamor Danek, Inc.2000—
*K030327Zephir Anterior Cervical System
Summary page 1
…nterior Cervical Plate System is substantially equivalent in intended use, materials, anatomical site to ZEPHIR Tm Anterior Cervical Plate System (K994239, K030327) Exhibit 4, Page 1 of 2…
Medtronic Sofamor Danek2003—

Also cleared against K994239: 15 other devices →

What descends from it? (44)

See all 44

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

NumberDeviceApplicantDecidedDescendants
K113509Lexus Anterior Cervical Plate SystemL&K BIOMED Co., Ltd.201219
K131200Aspiron Acp SystemU&I Corporation20137
K121862Rex Anterior Cervical Plate SystemDio Medical Co., Ltd.20127
K102265LDR Spine Usa C-Plate, TL Anterior Cervical Plate SystemLdr Spine USA20107
K140234Aspiron Acp SystemU&I Corp.20146
K121078Van Gogh Anterior Cervical Plate SystemAccel Spine20120

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?

  • None of the 2 ancestors has a recall.
  • Of its descendants, K113509 (L&K BIOMED Co., Ltd., 2012) has gone furthest, with 19 descendants of its own.
  • 15 other devices also cite its predicate K994239.

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 MaximaTM Anterior Cervical Plate System is intended for anterior fixation to the cervical spine. The specific clinical indications include:

degenerative disc disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.

Indications for use as stated in the FDA summary.

Also cleared against K994239

15 other devices cite the same predicate.

  • K182885Atlantis™ Anterior Cervical Plate, Divergence™ Anterior Cervical Fusion System, Premier™ Anterior Cervical…Medtronic Sofamor Danek USA, Inc. · 2019
  • K150834Atrax Anterior Cervical Plating SystemX-Spine Systems, Inc. · 2015
  • K141632Zevo (TM) Anterior Cervical Plate SystemMedtronic Sofamor Danek USA, Inc. · 20141 recall
  • K140234Aspiron Acp SystemU&I Corp. · 2014
  • K131200Aspiron Acp SystemU&I Corporation · 2013
  • K121078Van Gogh Anterior Cervical Plate SystemAccel Spine · 2012

More from U&I Corp.

12 FDA decisions under this applicant name. See the company

  • K140864Veloxtm Interbody Fusion SystemU&I Corp. · 2014
  • K140234Aspiron Acp SystemU&I Corp. · 2014
  • K132926Velofixtm Interbody Fusion SystemU&I Corp. · 2014
  • K120419Dyna Locking Ankle NailU&I Corp. · 2012
  • K112240Dyna Locking Cannulated ScrewU&I Corp. · 2012

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/K061002 · printed Nov 6, 2026

Cite this page

510(k) Report. “K061002: Maxima 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/K061002

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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