510(k) Report

510(k) · Cleared

Cleared

Atlantis Anterior Cervical Plate System

K993855510(k) SpecialCleared Dec 15, 199930-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

Danek Medical, Inc. · KWQ Appliance, Fixation, Spinal Intervertebral Body

Cleared on Dec 15, 1999 after a 30-day review. The FDA summary names no predicate by number. 295 later devices descend from it.

Decided
Dec 15, 1999
Review
30 days
Class
Class II
Product code
KWQ
Recalls
None
Predicates
0

295 later devices descend from it, 5 citing it directly.

Descendants, by year cleared 2012: 6 descendants cleared2005: 7 descendants cleared2000: 1 descendant cleared2004: 4 descendants cleared2010: 4 descendants cleared2002: 3 descendants cleared2003: 2 descendants cleared2015: 2 descendants cleared2017: 8 descendants cleared2013: 7 descendants cleared2014: 6 descendants cleared2020: 24 descendants cleared2016: 4 descendants cleared2022: 25 descendants cleared2007: 1 descendant cleared2008: 5 descendants cleared2009: 2 descendants cleared2019: 16 descendants cleared2021: 17 descendants cleared2023: 32 descendants cleared2011: 1 descendant cleared2018: 7 descendants cleared2024: 35 descendants cleared2025: 39 descendants cleared2006: 1 descendant cleared2026: 36 descendants cleared1995200020052010201520202025
  1. This deviceK993855 Atlantis Anterior Cervical Plate SystemDanek Medical, Inc. · 1999
  2. Descendant · cites it directly · 289 of its ownK000486 Abc Cervical Plating SystemAesculap, Inc. · 2000
  3. Descendant · 2 generations on · 145 of its ownK050813 Abc 2 ScrewAesculap, Inc. · 2005
  4. Descendant · 3 generations on · 132 of its ownK133475 Struxxure Anterior Cervical Plate and ScrewsNexxt Spine, LLC · 2013
  5. Descendant · 4 generations on · 106 of its ownK141376 Inertia Pedicle Screw System, Honour Spacer System, Facet Fixx…Nexxt Spine, LLC · 2014
  6. Descendant · 2 generations on · 101 of its ownK122910 Archon Anterior Cervical Plate Syste,Nu Vasive, Incorporated · 2012

Showing 5 of 295 descendants. See all descendants

Descendants cleared per year

2000: 12002: 32003: 22004: 42005: 72006: 12007: 12008: 52009: 22010: 42011: 12012: 62013: 72014: 62015: 22016: 42017: 82018: 72019: 162020: 242021: 172022: 252023: 322024: 352025: 392026: 36
2000high 39 (2025) · low 0 (2001)2026

Most influential descendants

Showing 5 of 295 · See all
  • K000486Abc Cervical Plating SystemAesculap, Inc. · 2000 · cites it directly289descendants
  • K050813Abc 2 ScrewAesculap, Inc. · 2005 · 2 generations on145descendants
  • K133475Struxxure Anterior Cervical Plate and ScrewsNexxt Spine, LLC · 2013 · 3 generations on132descendants
  • K141376Inertia Pedicle Screw System, Honour Spacer System, Facet Fixx, Struxxure Anterior…Nexxt Spine, LLC · 2014 · 4 generations on106descendants
  • K122910Archon Anterior Cervical Plate Syste,Nu Vasive, Incorporated · 2012 · 2 generations on101descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K993855Atlantis Anterior Cervical Plate SystemDanek Medical, Inc.1999—
+1K000486Abc Cervical Plating SystemAesculap, Inc.2000—
+2K050813Abc 2 ScrewAesculap, Inc.2005—
+3K133475Struxxure Anterior Cervical Plate and ScrewsNexxt Spine, LLC2013—
+4K141376Inertia Pedicle Screw System, Honour Spacer System, Facet Fixx, Struxxure…Nexxt Spine, LLC2014—
+2K122910Archon Anterior Cervical Plate Syste,Nu Vasive, Incorporated2012—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200010
200230
200320
200440
200570
200610
200710
200850
200920
201040
201110
201260
201370
201460
201520
201640
201780
201870
2019160
2020240
2021170
2022250
2023320
2024350
2025390
2026360
FIG. 1 — Lineage of K993855, 1999–2026Source: 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? (295)

See all 295

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

NumberDeviceApplicantDecidedDescendants
K000486Abc Cervical Plating SystemAesculap, Inc.2000289
K121514Anodyne Anterior Cervical Plate SystemCorelink, LLC201221
K050804Modification to: Spectrumtm Cervical Spinal SystemAesculap, Inc.200511
K112809Blue Mountain Cervical PlateQualgenix, LLC20122
K040401Lanx Anterior Cervial Plate SystemLanx, LLC20041

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, K000486 (Aesculap, Inc., 2000) has gone furthest, with 289 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 ATLANTIS™ 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 Danek Medical, Inc.

56 FDA decisions under this applicant name. See the company

  • K994122Bone Graft Washer, Model 9090114 - 9090118Danek Medical, Inc. · 2000
  • K993810CD Horizon Spinal SystemDanek Medical, Inc. · 2000
  • K991528Modification to Tenor Spinal System-Rod/Bolt ConnectorDanek Medical, Inc. · 1999
  • K990603Modification of the Zplate-Atl Anterior Fixation SystemDanek Medical, Inc. · 1999
  • K982875Modification to Zplate-Atl Anterior Fixation SystemDanek Medical, Inc. · 1999

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/K993855 · printed Nov 6, 2026

Cite this page

510(k) Report. “K993855: Atlantis 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/K993855

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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