510(k) Report

510(k) · Cleared

Cleared

Zephir Anterior Cervical Plate System

K994239510(k) TraditionalCleared Jun 19, 2000186-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

Medtronic Sofamor Danek, Inc. · KWQ Appliance, Fixation, Spinal Intervertebral Body

Cleared on Jun 19, 2000 after a 186-day review. The FDA summary names no predicate by number. 165 later devices descend from it.

Decided
Jun 19, 2000
Review
186 days
Class
Class II
Product code
KWQ
Recalls
None
Predicates
0

165 later devices descend from it, 16 citing it directly.

Descendants, by year cleared 2006: 3 descendants cleared2015: 10 descendants cleared2014: 4 descendants cleared2002: 4 descendants cleared2012: 8 descendants cleared2003: 3 descendants cleared2019: 14 descendants cleared2010: 3 descendants cleared2013: 6 descendants cleared2009: 2 descendants cleared2005: 2 descendants cleared2020: 8 descendants cleared2011: 1 descendant cleared2021: 10 descendants cleared2004: 3 descendants cleared2016: 6 descendants cleared2022: 10 descendants cleared2023: 17 descendants cleared2018: 4 descendants cleared2024: 11 descendants cleared2017: 8 descendants cleared2008: 2 descendants cleared2026: 13 descendants cleared2025: 13 descendants cleared200020052010201520202025
  1. This deviceK994239 Zephir Anterior Cervical Plate SystemMedtronic Sofamor Danek, Inc. · 2000
  2. Descendant · cites it directly · 85 of its ownK012184 Blackstone Iii Anterior Cervical Plating SystemBlackstone Medical, Inc. · 2002
  3. Descendant · cites it directly · 66 of its ownK030595 Blackstone Fusion Anterior Cervical Plating SystemBlackstone Medical, Inc. · 2003
  4. Descendant · 2 generations on · 52 of its ownK050892 Hallmarktm Anterior Cervical Plate SystemBlackstone Medical, Inc. · 2005 · Recalled
  5. Descendant · 3 generations on · 51 of its ownK100614 Hallmark Anterior Cervcial Plate System, Hallmark Five-Level…Blackstone Medical, Inc. · 2010
  6. Descendant · cites it directly · 44 of its ownK061002 Maxima Anterior Cervical Plate SystemU&I Corp. · 2006

Showing 5 of 165 descendants. See all descendants

Descendants cleared per year

2002: 42003: 32004: 32005: 22006: 32008: 22009: 22010: 32011: 12012: 82013: 62014: 42015: 102016: 62017: 82018: 42019: 142020: 82021: 102022: 102023: 172024: 112025: 132026: 13
2002high 17 (2023) · low 0 (2007)2026

Most influential descendants

Showing 5 of 165 · See all
  • K012184Blackstone Iii Anterior Cervical Plating SystemBlackstone Medical, Inc. · 2002 · cites it directly85descendants
  • K030595Blackstone Fusion Anterior Cervical Plating SystemBlackstone Medical, Inc. · 2003 · cites it directly66descendants
  • K050892Hallmarktm Anterior Cervical Plate SystemBlackstone Medical, Inc. · 2005 · 2 generations on52descendants
  • K100614Hallmark Anterior Cervcial Plate System, Hallmark Five-Level Cervical PlatesBlackstone Medical, Inc. · 2010 · 3 generations on51descendants
  • K061002Maxima Anterior Cervical Plate SystemU&I Corp. · 2006 · cites it directly44descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K994239Zephir Anterior Cervical Plate SystemMedtronic Sofamor Danek, Inc.2000—
+1K012184Blackstone Iii Anterior Cervical Plating SystemBlackstone Medical, Inc.2002—
+1K030595Blackstone Fusion Anterior Cervical Plating SystemBlackstone Medical, Inc.2003—
+2K050892Hallmarktm Anterior Cervical Plate SystemBlackstone Medical, Inc.20052
+3K100614Hallmark Anterior Cervcial Plate System, Hallmark Five-Level Cervical PlatesBlackstone Medical, Inc.2010—
+1K061002Maxima Anterior Cervical Plate SystemU&I Corp.2006—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200240
200330
200430
200520
200630
200820
200920
201030
201110
201280
201360
201440
2015100
201660
201780
201840
2019140
202080
2021100
2022100
2023170
2024110
2025130
2026130
FIG. 1 — Lineage of K994239, 2000–2026Source: 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?

The FDA summary names no predicate by number.

What descends from it? (165)

See all 165

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

NumberDeviceApplicantDecidedDescendants
K012184Blackstone Iii Anterior Cervical Plating SystemBlackstone Medical, Inc.200285
K030595Blackstone Fusion Anterior Cervical Plating SystemBlackstone Medical, Inc.200366
K061002Maxima Anterior Cervical Plate SystemU&I Corp.200644
K022344Trinica Select Anterior Cervical Plate SystemCenterpulse Spine-Tech, Inc.200243
K113509Lexus Anterior Cervical Plate SystemL&K BIOMED Co., Ltd.201219
K141632Zevo (TM) Anterior Cervical Plate SystemMedtronic Sofamor Danek USA, Inc.201418
K083338Cardiff Anterior Cervical Plate SystemSeaspine, Inc.200916
K182885Atlantis™ Anterior Cervical Plate, Divergence™ Anterior Cervical Fusion System, Premier™…Medtronic Sofamor Danek USA, Inc.20198
K092474Pyrenees Cervical Plate System, Semi-Constrained ScrewsK2m, Inc.20108
K131200Aspiron Acp SystemU&I Corporation20137

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?

  • Of its descendants, K012184 (Blackstone Medical, Inc., 2002) has gone furthest, with 85 descendants of its own.

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 ZEPHIR™ Anterior Cervical Plate System is intended for anterior interbody screw fixation of the cervical spine. The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusions in patients with degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumors, deformity (defined as kyphosis, lordosis, or scoliosis), pseudarthrosis, and/or failed previous fusions.

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

More from Medtronic Sofamor Danek, Inc.

125 FDA decisions under this applicant name. See the company

  • K251193Grafton™ DBM; Grafton Plus™ DBM Paste; Magnifuse™ Bone GraftMedtronic Sofamor Danek, Inc. · 2025
  • K243706Mastergraft Matrix EXT; Mastergraft Strip; Mastergraft Putty; Mastergraft GranulesMedtronic Sofamor Danek, Inc. · 2025
  • K230716Robotic Graft Delivery InstrumentsMedtronic Sofamor Danek, Inc. · 2023
  • P060018/S005Prestige Cervical Disc SystemMedtronic Sofamor Danek, Inc. · 2016
  • P060018/S004PRESTIGE® Cervical DiscMedtronic Sofamor Danek, Inc. · 2016

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/K994239 · printed Nov 3, 2026

Cite this page

510(k) Report. “K994239: Zephir 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/K994239

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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