510(k) Report

510(k) · Cleared

Cleared

Axis Anterior Cervical Plate System

K173867510(k) TraditionalCleared Apr 5, 2018106-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

Axis Orthopaedics · KWQ Appliance, Fixation, Spinal Intervertebral Body

Cleared on Apr 5, 2018 as substantially equivalent to K021461 (Medtronic Sofamor Danek, 2002) and 3 other predicates after a 106-day review. Its family tree reaches back 5 generations to 2003. 1 later device descends from it.

Decided
Apr 5, 2018
Review
106 days
Class
Class II
Product code
KWQ
Recalls
None
Predicates
4

Its longest line of descent runs back 5 generations to K031276 (2003). 13 ancestors in all, the oldest K792352 (1979). 1 later device descends from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2009: 1 other ancestor2002: 1 other ancestor2007: 1 other ancestor2004: 2 other ancestors1993: 1 other ancestor1979: 1 other ancestor1992: 1 other ancestor2020: 1 descendant clearedK031276 · Synthes Anterior Cervical Locking Plate (Aclp) System · Synthes (Usa) · 2003K033844 · Synthes Anterior Cervical Compression System · Synthes (Usa) · 2004K050451 · Synthes Vectra System · Synthes Spine Co.Lp · 2005 · recalledK071667 · Synthes Vectra-One System · Synthes Spine · 2007 · recalledK143576 · Exactech Ambassador · Exactech, Inc. · 2015 · recalled19801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors2 generations back: 2 other ancestors3 generations back: 3 other ancestors4 generations back: 1 other ancestor 1 generation forward: 1 descendant K143576 · Exactech Ambassador · Exactech, Inc. · 2015 · recalledK071667 · Synthes Vectra-One System · Synthes Spine · 2007 · recalledK050451 · Synthes Vectra System · Synthes Spine Co.Lp · 2005 · recalledK033844 · Synthes Anterior Cervical Compression System · Synthes (Usa) · 2004K031276 · Synthes Anterior Cervical Locking Plate (Aclp) System · Synthes (Usa) · 2003−50
  1. Root · 5 generations backK031276 Synthes Anterior Cervical Locking Plate (Aclp) SystemSynthes (Usa) · 2003
  2. 4 generations backK033844 Synthes Anterior Cervical Compression SystemSynthes (Usa) · 2004
  3. 3 generations backK050451 Synthes Vectra SystemSynthes Spine Co.Lp · 2005 · Recalled
  4. 2 generations backK071667 Synthes Vectra-One SystemSynthes Spine · 2007 · Recalled
  5. 1 generation backK143576 Exactech AmbassadorExactech, Inc. · 2015 · Recalled
  6. This deviceK173867 Axis Anterior Cervical Plate SystemAxis Orthopaedics · 2018
  7. Descendant · cites it directly · 0 of its ownK203154 KASILOF Cervical Plate SystemKahtnu Surgical, Inc. · 2020

Most influential descendants

Showing 1 of 1 · See all
  • K203154KASILOF Cervical Plate SystemKahtnu Surgical, Inc. · 2020 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−5K031276Synthes Anterior Cervical Locking Plate (Aclp) SystemSynthes (Usa)2003—
−4K033844Synthes Anterior Cervical Compression SystemSynthes (Usa)2004—
−3K050451Synthes Vectra SystemSynthes Spine Co.Lp20053
−2K071667Synthes Vectra-One SystemSynthes Spine20073
−1K143576Exactech AmbassadorExactech, Inc.20151
0 (this device)K173867Axis Anterior Cervical Plate SystemAxis Orthopaedics2018—
+1K203154KASILOF Cervical Plate SystemKahtnu Surgical, Inc.2020—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
197910
199210
199310
200210
200420
200710
200910

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202010
FIG. 1 — Lineage of K173867, 2003–2020Source: 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? (4)

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
*K021461Atlantis Vision Anterior Cervical Plate System
Summary page 5
…failed previous fusion). K173867 - page 2 of 2 Legally Marketed Predicate Devices: Primary: Medtronic Atlantis Vision Anterior Cervical Plate System (K021461) Secondary: Exactech Ambassador Anterior Cervical Plate System (K091926 and K143576) DePuy Synthes Vectra Anterior Cervical Plat…
Medtronic Sofamor Danek20023
*K091926Choice Spine Anterior Cervical Plate (Acp) System
Summary page 5
…Marketed Predicate Devices: Primary: Medtronic Atlantis Vision Anterior Cervical Plate System (K021461) Secondary: Exactech Ambassador Anterior Cervical Plate System (K091926 and K143576) DePuy Synthes Vectra Anterior Cervical Plate System (K031276) Implant Materials Material: Standard: Ti-6Al-4V ASTM…
Choicespine, LP2009—
*K143576Exactech Ambassador
Summary page 5
…dicate Devices: Primary: Medtronic Atlantis Vision Anterior Cervical Plate System (K021461) Secondary: Exactech Ambassador Anterior Cervical Plate System (K091926 and K143576) DePuy Synthes Vectra Anterior Cervical Plate System (K031276) Implant Materials Material: Standard: Ti-6Al-4V ASTM F136-13 Tec…
Exactech, Inc.20151
*K031276Synthes Anterior Cervical Locking Plate (Aclp) System
Summary page 5
…Cervical Plate System (K021461) Secondary: Exactech Ambassador Anterior Cervical Plate System (K091926 and K143576) DePuy Synthes Vectra Anterior Cervical Plate System (K031276) Implant Materials Material: Standard: Ti-6Al-4V ASTM F136-13 Technological Characteristics: There are no technological charact…
Synthes (Usa)2003—

Also cleared against K021461: 13 other devices →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K203154KASILOF Cervical Plate SystemKahtnu Surgical, Inc.20200

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?

  • The line of descent spans 15 years and passes through 5 companies; a new generation was cleared every 2.7 years on median.
  • 4 of the 13 ancestors have a recall of any class.
  • Of its descendants, K203154 (Kahtnu Surgical, Inc., 2020) has gone furthest, with 0 descendants of its own.
  • 13 other devices also cite its predicate K021461.

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. 2018, 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 Axis Anterior Cervical Plate System is intended for anterior screw fixation to the cervical spine. It is to be used in skeletally mature patients as an adjunct to fusion from levels C2 through T1 of the cervical spine. The system is indicated for use in the stabilization of the anterior cervical spine during the development of cervical spinal fusion in patients. The indications include spinal stenosis, degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies,), tumors, deformity (defined by kyphosis, lordosis, or scoliosis), and/or pseudoarthrosis (defined as failed previous fusion).

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

Also cleared against K021461

13 other devices cite the same predicate.

  • K252776ARIES Anterior Cervical Plate SystemsZheJiang Decans Medical Devices Co., Ltd. · 2026
  • K203154KASILOF Cervical Plate SystemKahtnu Surgical, Inc. · 2020
  • K182885Atlantis™ Anterior Cervical Plate, Divergence™ Anterior Cervical Fusion System, Premier™ Anterior Cervical…Medtronic Sofamor Danek USA, Inc. · 2019
  • K152623ATLANTIS Anterior Cervical Plate SystemMedtronic Sofamor Danek USA, Inc. · 2015
  • K131025Archon Anterior Cervical Plate SystemNuvasive, Inc. · 2013
  • K130640Atlantis Anterior Cervical Plate SystemMedtronic Sofamor Danek USA, Inc. · 2013

More from Axis Orthopaedics

3 FDA decisions under this applicant name. See the company

  • K181140Axis Chena Cervical PEEK Spacer SystemAxis Orthopaedics · 2018
  • K180301AXIS 5.5 Lumbar Pedicle Screw SystemAxis Orthopaedics · 2018

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/K173867 · printed Nov 6, 2026

Cite this page

510(k) Report. “K173867: Axis 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/K173867

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