510(k) Report

510(k) · Cleared

Cleared

NexGen Anterior Cervical Plate System

K192494510(k) TraditionalCleared Oct 29, 201948-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

Precision Spine · KWQ Appliance, Fixation, Spinal Intervertebral Body

Cleared on Oct 29, 2019 as substantially equivalent to K160702 (Astura Medical, 2016) and 5 other predicates after a 48-day review. Its family tree reaches back 6 generations to 1995.

Decided
Oct 29, 2019
Review
48 days
Class
Class II
Product code
KWQ
Recalls
None
Predicates
6

Its longest line of descent runs back 6 generations to K953730 (1995). 27 ancestors in all, the oldest K914362 (1992). No later device cites it as a predicate yet.

Other ancestors, by year cleared 2010: 1 other ancestor2008: 1 other ancestor2004: 2 other ancestors2000: 3 other ancestors2013: 1 other ancestor2007: 1 other ancestor2006: 2 other ancestors1992: 1 other ancestor2003: 2 other ancestors2002: 1 other ancestor2001: 1 other ancestor1997: 2 other ancestors1998: 1 other ancestor1995: 1 other ancestor1993: 1 other ancestorReference device: K162211 · AccuFit Lateral Plate System · Precision Spine, Inc. · 2016K953730 · 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 · recalledK160702 · ZION Anterior Cervical Fixation System · Astura Medical · 20161990199520002005201020152020
Other ancestors, by generation 1 generation back: 4 other ancestors2 generations back: 6 other ancestors3 generations back: 6 other ancestors4 generations back: 4 other ancestors5 generations back: 1 other ancestor K160702 · ZION Anterior Cervical Fixation System · Astura Medical · 2016K080646 · 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 · 6 generations backK953730 Codman Anterior Cervical Plate SystemJohnson & Johnson Professionals, Inc. · 1995
  2. 5 generations backK013877 Codman Slim-Loc SystemCodman & Shurtleff, Inc. · 2001
  3. 4 generations backK040655 Swift Anterior Cervical Plate SystemDepuy Spine, Inc. · 2004
  4. 3 generations backK072546 Swift Plus Anterior Cervical Plate SystemDepuy Spine, Inc. · 2007
  5. 2 generations backK080646 C-Tek Maxan Anterior Cervical Plate SystemBiomet Spine · 2008 · Recalled
  6. 1 generation backK160702 ZION Anterior Cervical Fixation SystemAstura Medical · 2016
  7. This deviceK192494 NexGen Anterior Cervical Plate SystemPrecision Spine · 2019
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−6K953730Codman Anterior Cervical Plate SystemJohnson & Johnson Professionals, Inc.1995—
−5K013877Codman Slim-Loc SystemCodman & Shurtleff, Inc.2001—
−4K040655Swift Anterior Cervical Plate SystemDepuy Spine, Inc.2004—
−3K072546Swift Plus Anterior Cervical Plate SystemDepuy Spine, Inc.2007—
−2K080646C-Tek Maxan Anterior Cervical Plate SystemBiomet Spine20082
−1K160702ZION Anterior Cervical Fixation SystemAstura Medical2016—
0 (this device)K192494NexGen Anterior Cervical Plate SystemPrecision Spine2019—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199210
199310
199510
199720
199810
200030
200110
200210
200320
200420
200620
200710
200810
201010
201310
FIG. 1 — Lineage of K192494, 1995–2019Source: 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? (6)

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
*K160702ZION Anterior Cervical Fixation System
Summary page 4
…CFR Section 21 CFR section 888.3060 Device Panel Orthopedic Primary Predicate Zion Anterior Cervical Plating System, Astura Medical (K160702) Device Secondary Predicate C-Tek® MaxAn™Anterior Cervical Plate System, Biomet (K080646) Devices CSLP Ce…
Astura Medical2016—
*K080646C-Tek Maxan Anterior Cervical Plate System
Summary page 4
…y Predicate Zion Anterior Cervical Plating System, Astura Medical (K160702) Device Secondary Predicate C-Tek® MaxAn™Anterior Cervical Plate System, Biomet (K080646) Devices CSLP Cervical Plate, Synthes (K000536) UNIPLATE, DePuy (K042544 / K082273 /…
Biomet Spine20082
*K000536Synthes Anterior CSLP System
Summary page 4
…Medical (K160702) Device Secondary Predicate C-Tek® MaxAn™Anterior Cervical Plate System, Biomet (K080646) Devices CSLP Cervical Plate, Synthes (K000536) UNIPLATE, DePuy (K042544 / K082273 / K100070) Reference Device AccuFit™ Lateral Plate Syste…
Synthes Spine20001
*K042544Uniplate Anterior Cervical Plate System
Summary page 4
…C-Tek® MaxAn™Anterior Cervical Plate System, Biomet (K080646) Devices CSLP Cervical Plate, Synthes (K000536) UNIPLATE, DePuy (K042544 / K082273 / K100070) Reference Device AccuFit™ Lateral Plate System, Precision Spine (K162211)…
Depuy Spine, Inc.2004—
*K082273Uniplate Anterior Cervical Plate System
Summary page 4
…An™Anterior Cervical Plate System, Biomet (K080646) Devices CSLP Cervical Plate, Synthes (K000536) UNIPLATE, DePuy (K042544 / K082273 / K100070) Reference Device AccuFit™ Lateral Plate System, Precision Spine (K162211) The Ne…
Depuy Spine, Inc.2008—
*K100070Uniplate Anterior Cervical Plate System
Summary page 4
…r Cervical Plate System, Biomet (K080646) Devices CSLP Cervical Plate, Synthes (K000536) UNIPLATE, DePuy (K042544 / K082273 / K100070) Reference Device AccuFit™ Lateral Plate System, Precision Spine (K162211) The NexGen Anter…
Depuy Spine, Inc.2010—
†K162211AccuFit Lateral Plate SystemPrecision Spine, Inc.2016—

Also cleared against K160702: 2 other devices →

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 24 years and passes through 6 companies; a new generation was cleared every 3.3 years on median.
  • 4 of the 27 ancestors have a recall of any class.
  • 2 other devices also cite its predicate K160702.

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. 2019, 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 NexGen Anterior Cervical Plate System is indicated for use in temporary stabilization of the anterior spine from C2 to T1 during the development of cervical spinal fusions in patients with: degenerative disc disease (DDD) (as defined by neck pain of discogenic origin with degeneration of disc confirmed by patient history and radiographic studies); spondylolisthesis; trauma (including fractures or dislocations); spinal tumors; deformity (defined as kyphosis, lordosis, or scoliosis); spinal stenosis; pseudoarthrosis; and failed previous fusions.

Indications for use as stated in the FDA summary.

Also cleared against K160702

2 other devices cite the same predicate.

  • K250446Frida™ Anterior Cervical Plate SystemSpineup, Inc. · 2025
  • K213456Xenco Medical Multilevel CerviKitXenco Medical, LLC · 2021

More from Precision Spine

2 FDA decisions under this applicant name. See the company

  • K200303Reform Pedicle Screw SystemPrecision Spine · 2020

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/K192494 · printed Nov 6, 2026

Cite this page

510(k) Report. “K192494: NexGen 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/K192494

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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