510(k) Report

510(k) · Cleared

Cleared

Velox Anterior Cervical Plate System

K131521510(k) TraditionalCleared Dec 24, 2013210-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

Spinecraft, LLC · KWQ Appliance, Fixation, Spinal Intervertebral Body

Cleared on Dec 24, 2013 as substantially equivalent to K020649 (Ortho Development Corp., 2002) and 6 other predicates after a 210-day review. Its family tree reaches back 5 generations to 1995.

Decided
Dec 24, 2013
Review
210 days
Class
Class II
Product code
KWQ
Recalls
None
Predicates
7

Its longest line of descent runs back 5 generations to K953730 (1995). 17 ancestors in all, the oldest K914362 (1992). No later device cites it as a predicate yet.

Other ancestors, by year cleared 2011: 1 other ancestor2010: 1 other ancestor2008: 1 other ancestor2004: 2 other ancestors2002: 1 other ancestor2000: 1 other ancestor2007: 1 other ancestor2006: 1 other ancestor2005: 1 other ancestor1997: 1 other ancestor1992: 1 other ancestorK953730 · Codman Anterior Cervical Plate System · Johnson & Johnson Professionals, Inc. · 1995K013877 · Codman Slim-Loc System · Codman & Shurtleff, Inc. · 2001K040655 · Swift Anterior Cervical Plate System · Depuy Spine, Inc. · 2004K072546 · Swift Plus Anterior Cervical Plate System · Depuy Spine, Inc. · 2007K080646 · C-Tek Maxan Anterior Cervical Plate System · Biomet Spine · 2008 · recalled199019952000200520102015
Other ancestors, by generation 1 generation back: 6 other ancestors2 generations back: 6 other ancestors K080646 · C-Tek Maxan Anterior Cervical Plate System · Biomet Spine · 2008 · recalledK072546 · Swift Plus Anterior Cervical Plate System · Depuy Spine, Inc. · 2007K040655 · Swift Anterior Cervical Plate System · Depuy Spine, Inc. · 2004K013877 · Codman Slim-Loc System · Codman & Shurtleff, Inc. · 2001K953730 · Codman Anterior Cervical Plate System · Johnson & Johnson Professionals, Inc. · 1995−50
  1. Root · 5 generations backK953730 Codman Anterior Cervical Plate SystemJohnson & Johnson Professionals, Inc. · 1995
  2. 4 generations backK013877 Codman Slim-Loc SystemCodman & Shurtleff, Inc. · 2001
  3. 3 generations backK040655 Swift Anterior Cervical Plate SystemDepuy Spine, Inc. · 2004
  4. 2 generations backK072546 Swift Plus Anterior Cervical Plate SystemDepuy Spine, Inc. · 2007
  5. 1 generation backK080646 C-Tek Maxan Anterior Cervical Plate SystemBiomet Spine · 2008 · Recalled
  6. This deviceK131521 Velox Anterior Cervical Plate SystemSpinecraft, LLC · 2013
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−5K953730Codman Anterior Cervical Plate SystemJohnson & Johnson Professionals, Inc.1995—
−4K013877Codman Slim-Loc SystemCodman & Shurtleff, Inc.2001—
−3K040655Swift Anterior Cervical Plate SystemDepuy Spine, Inc.2004—
−2K072546Swift Plus Anterior Cervical Plate SystemDepuy Spine, Inc.2007—
−1K080646C-Tek Maxan Anterior Cervical Plate SystemBiomet Spine20082
0 (this device)K131521Velox Anterior Cervical Plate SystemSpinecraft, LLC2013—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199210
199710
200010
200210
200420
200510
200610
200710
200810
201010
201110
FIG. 1 — Lineage of K131521, 1995–2013Source: 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? (7)

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
*K020649Envision Anterior Cervical Plate System
Summary page 2
…on. Substantial equivalence claimed to predicate devices VELOX Anterior Cervical Plate system is substantially equivalent to the Envision Anterior Cervical Plate System (K020649), ALTUM Anterior Cervical Plate (K103505) and MaxAn Anterior Cervical Plate System (K080646) in terms of intended use, design, ma…
Ortho Development Corp.2002—
*K103505Altum Anterior Cervical Plate
Summary page 1
…ate or legally marketed devices which'are substantially equivalent: Envision Anterior Cervical Plate System (K(020649) / Ortho Development ALTUM Anterior Cervical Plate (K1 03505) / SpineCraft C-Tek MaxAn Anterior Cervical Plate System (K080646) IBiomet Spine UNIPLATE Anterior Cervical Plate (K(042544 /1K08…
Spinecraft, LLC20111
*K080646C-Tek Maxan Anterior Cervical Plate System
Summary page 1
…Envision Anterior Cervical Plate System (K(020649) / Ortho Development ALTUM Anterior Cervical Plate (K1 03505) / SpineCraft C-Tek MaxAn Anterior Cervical Plate System (K080646) IBiomet Spine UNIPLATE Anterior Cervical Plate (K(042544 /1K082273 /K100070) / DePuy CLSP Cervical Plate (K000536) / Synthes Des…
Biomet Spine20082
*K042544Uniplate Anterior Cervical Plate System
Summary page 1
…Development ALTUM Anterior Cervical Plate (K1 03505) / SpineCraft C-Tek MaxAn Anterior Cervical Plate System (K080646) IBiomet Spine UNIPLATE Anterior Cervical Plate (K(042544 /1K082273 /K100070) / DePuy CLSP Cervical Plate (K000536) / Synthes Description of the device: The VELOX Anterior Cervical Plate…
Depuy Spine, Inc.2004—
*K082273Uniplate Anterior Cervical Plate System
Summary page 1
…ent ALTUM Anterior Cervical Plate (K1 03505) / SpineCraft C-Tek MaxAn Anterior Cervical Plate System (K080646) IBiomet Spine UNIPLATE Anterior Cervical Plate (K(042544 /1K082273 /K100070) / DePuy CLSP Cervical Plate (K000536) / Synthes Description of the device: The VELOX Anterior Cervical Plate System is…
Depuy Spine, Inc.2008—
*K100070Uniplate Anterior Cervical Plate System
Summary page 1
…Anterior Cervical Plate (K1 03505) / SpineCraft C-Tek MaxAn Anterior Cervical Plate System (K080646) IBiomet Spine UNIPLATE Anterior Cervical Plate (K(042544 /1K082273 /K100070) / DePuy CLSP Cervical Plate (K000536) / Synthes Description of the device: The VELOX Anterior Cervical Plate System is intended…
Depuy Spine, Inc.2010—
*K000536Synthes Anterior CSLP System
Summary page 1
…SpineCraft C-Tek MaxAn Anterior Cervical Plate System (K080646) IBiomet Spine UNIPLATE Anterior Cervical Plate (K(042544 /1K082273 /K100070) / DePuy CLSP Cervical Plate (K000536) / Synthes Description of the device: The VELOX Anterior Cervical Plate System is intended for anterior screw fixation of the pla…
Synthes Spine20001

Also cleared against K020649: 1 other device →

What descends from it?

No later submission names this one as a predicate yet.

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 18 years and passes through 5 companies; a new generation was cleared every 3.3 years on median.
  • 3 of the 17 ancestors have a recall of any class.
  • 1 other device also cites its predicate K020649.

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. 2013, 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 VELOX 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 of the cervical spine (C2 to C7). The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusion 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),

* spondylolisthesis,

* trauma (i.e. fractures or dislocations),

* tumors,

* deformity,

* pseudarthrosis,

* failed previous fusion,

* spinal stenosis.

Indications for use as stated in the FDA summary.

Also cleared against K020649

1 other device cites the same predicate.

  • K103505Altum Anterior Cervical PlateSpinecraft, LLC · 20111 recall

More from Spinecraft, LLC

12 FDA decisions under this applicant name. See the company

  • K223301ASTRA & AVANT Navigation Instruments System and ASTRA-OCT Navigation Instruments SystemSpinecraft, LLC · 2023
  • K223273ASTRA Spine SystemSpinecraft, LLC · 2022
  • K211935ORIO-Ti Intervertebral Body Fusion Cage SystemSpinecraft, LLC · 2021
  • K211323ASTRA Spine SystemSpinecraft, LLC · 2021
  • K181350ASTRA-OCT Spine SystemSpinecraft, LLC · 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/K131521 · printed Nov 6, 2026

Cite this page

510(k) Report. “K131521: Velox 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/K131521

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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