510(k) Report

510(k) · Cleared

Cleared

Acpii Anterior Cervical Plate System

K970806510(k) TraditionalCleared May 2, 199758-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

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

Cleared on May 2, 1997 after a 58-day review. The FDA summary names no predicate by number. 36 later devices descend from it.

Decided
May 2, 1997
Review
58 days
Class
Class II
Product code
KWQ
Recalls
None
Predicates
0

36 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2008: 1 descendant cleared2019: 4 descendants cleared2014: 4 descendants cleared2013: 2 descendants cleared2020: 1 descendant cleared2015: 3 descendants cleared2026: 3 descendants cleared2017: 1 descendant cleared2023: 5 descendants cleared2024: 4 descendants cleared2021: 1 descendant cleared2025: 5 descendants cleared2022: 1 descendant cleared2016: 1 descendant cleared1995200020052010201520202025
  1. This deviceK970806 Acpii Anterior Cervical Plate SystemSofamor Danek USA,Inc. · 1997
  2. Descendant · cites it directly · 35 of its ownK081038 Atlantis Anterior Cervical Plate SystemMedtronic Sofamor Danek · 2008 · Recalled
  3. Descendant · 2 generations on · 32 of its ownK130640 Atlantis Anterior Cervical Plate SystemMedtronic Sofamor Danek USA, Inc. · 2013
  4. Descendant · 2 generations on · 18 of its ownK141632 Zevo (TM) Anterior Cervical Plate SystemMedtronic Sofamor Danek USA, Inc. · 2014 · Recalled
  5. Descendant · 3 generations on · 16 of its ownK141599 Divergence Anterior Cervical Fusion SystemMedtronic Sofamor Danek USA, Inc. · 2015
  6. Descendant · 3 generations on · 11 of its ownK140417 Divergence Mini-Plate Anterior Cervical Fusion SystemMedtronic Sofamor Danek, Inc. · 2014

Showing 5 of 36 descendants. See all descendants

Descendants cleared per year

2008: 12013: 22014: 42015: 32016: 12017: 12019: 42020: 12021: 12022: 12023: 52024: 42025: 52026: 3
2008high 5 (2023) · low 0 (2009)2026

Most influential descendants

Showing 5 of 36 · See all
  • K081038Atlantis Anterior Cervical Plate SystemMedtronic Sofamor Danek · 2008 · cites it directly35descendants
  • K130640Atlantis Anterior Cervical Plate SystemMedtronic Sofamor Danek USA, Inc. · 2013 · 2 generations on32descendants
  • K141632Zevo (TM) Anterior Cervical Plate SystemMedtronic Sofamor Danek USA, Inc. · 2014 · 2 generations on18descendants
  • K141599Divergence Anterior Cervical Fusion SystemMedtronic Sofamor Danek USA, Inc. · 2015 · 3 generations on16descendants
  • K140417Divergence Mini-Plate Anterior Cervical Fusion SystemMedtronic Sofamor Danek, Inc. · 2014 · 3 generations on11descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K970806Acpii Anterior Cervical Plate SystemSofamor Danek USA,Inc.1997—
+1K081038Atlantis Anterior Cervical Plate SystemMedtronic Sofamor Danek20083
+2K130640Atlantis Anterior Cervical Plate SystemMedtronic Sofamor Danek USA, Inc.2013—
+2K141632Zevo (TM) Anterior Cervical Plate SystemMedtronic Sofamor Danek USA, Inc.20141
+3K141599Divergence Anterior Cervical Fusion SystemMedtronic Sofamor Danek USA, Inc.2015—
+3K140417Divergence Mini-Plate Anterior Cervical Fusion SystemMedtronic Sofamor Danek, Inc.2014—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200810
201320
201440
201530
201610
201710
201940
202010
202110
202210
202350
202440
202550
202630
FIG. 1 — Lineage of K970806, 1997–2026Source: 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
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What was it cleared against?

The FDA summary names no predicate by number.

What descends from it? (36)

See all 36

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

NumberDeviceApplicantDecidedDescendants
K081038Atlantis Anterior Cervical Plate SystemMedtronic Sofamor Danek200835
K182885Atlantis™ Anterior Cervical Plate, Divergence™ Anterior Cervical Fusion System, Premier™…Medtronic Sofamor Danek USA, Inc.20198

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, K081038 (Medtronic Sofamor Danek, 2008) has gone furthest, with 35 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 ACPii 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 Sofamor Danek USA,Inc.

41 FDA decisions under this applicant name. See the company

  • K991031Colorado II Spinal SystemSofamor Danek USA,Inc. · 20001 recall
  • K984360Colorado II Spinal SystemSofamor Danek USA,Inc. · 2000
  • K992928CD Horizon Spinal SystemSofamor Danek USA,Inc. · 1999
  • K991036Danek Plate and Screw SystemSofamor Danek USA,Inc. · 1999
  • K991198Dyna-Lok Plus Spinal SystemSofamor Danek USA,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/K970806 · printed Nov 4, 2026

Cite this page

510(k) Report. “K970806: Acpii Anterior Cervical Plate System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K970806

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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