510(k) Report

510(k) · Cleared

Cleared

Stryker Spine Reflex Translational Anterior Cervical Plating System

K083020510(k) SpecialCleared Mar 26, 2009168-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

Stryker Corp. · KWQ Appliance, Fixation, Spinal Intervertebral Body

Cleared on Mar 26, 2009 as substantially equivalent to K062310 (Stryker Spine, 2006) and 3 other predicates after a 168-day review. Its family tree reaches back 2 generations to 2000. 3 later devices descend from it.

Decided
Mar 26, 2009
Review
168 days
Class
Class II
Product code
KWQ
Recalls
None
Predicates
4

Its longest line of descent runs back 2 generations to K000536 (2000). 4 ancestors in all. 3 later devices descend from it, 2 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2004: 1 other ancestor2000: 1 other ancestor2022: 1 descendant cleared2024: 1 descendant cleared2023: 1 descendant clearedK000536 · Synthes Anterior CSLP System · Synthes Spine · 2000 · recalledK062310 · Reflex Hybrid Acp System · Stryker Spine · 2006 · recalled200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors 1 generation forward: 2 descendants2 generations forward: 1 descendant K062310 · Reflex Hybrid Acp System · Stryker Spine · 2006 · recalledK000536 · Synthes Anterior CSLP System · Synthes Spine · 2000 · recalled0
  1. Root · 2 generations backK000536 Synthes Anterior CSLP SystemSynthes Spine · 2000 · Recalled
  2. 1 generation backK062310 Reflex Hybrid Acp SystemStryker Spine · 2006 · Recalled
  3. This deviceK083020 Stryker Spine Reflex Translational Anterior Cervical Plating SystemStryker Corp. · 2009
  4. Descendant · cites it directly · 1 of its ownK221728 Aviator® Anterior Cervical Plating (ACP) System, LITe® Plate System…Stryker Corporation · 2022
  5. Descendant · cites it directly · 0 of its ownK240592 Wolff's Law Anterior Cervical Plate SystemSpinal Simplicity, LLC · 2024
  6. Descendant · 2 generations on · 0 of its ownK230424 Omnia Medical Coupler-A™ Anterior Lumbar Plate System; Omnia Medical…Omnia Medical, LLC · 2023

Most influential descendants

Showing 3 of 3 · See all
  • K221728Aviator® Anterior Cervical Plating (ACP) System, LITe® Plate System, DynaTran™ Anterior…Stryker Corporation · 2022 · cites it directly1descendant
  • K240592Wolff's Law Anterior Cervical Plate SystemSpinal Simplicity, LLC · 2024 · cites it directly0descendants
  • K230424Omnia Medical Coupler-A™ Anterior Lumbar Plate System; Omnia Medical Coupler-L™ Lateral…Omnia Medical, LLC · 2023 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K000536Synthes Anterior CSLP SystemSynthes Spine20001
−1K062310Reflex Hybrid Acp SystemStryker Spine20062
0 (this device)K083020Stryker Spine Reflex Translational Anterior Cervical Plating SystemStryker Corp.2009—
+1K221728Aviator® Anterior Cervical Plating (ACP) System, LITe® Plate System, DynaTran™…Stryker Corporation2022—
+1K240592Wolff's Law Anterior Cervical Plate SystemSpinal Simplicity, LLC2024—
+2K230424Omnia Medical Coupler-A™ Anterior Lumbar Plate System; Omnia Medical…Omnia Medical, LLC2023—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200010
200410

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202210
202310
202410
FIG. 1 — Lineage of K083020, 2000–2024Source: 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? (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
*K062310Reflex Hybrid Acp System
Summary page 1
…astryker.com Date Summary Prepared: October 7, 2008 Predicate Device Stryker Spine Reflex® Hybrid ACP System (K0623 10, K040261) and Synthes Spine Cervical Spine Locking Plate…
Stryker Spine20062
*K040261Reflex Hybrid Anterior Cervical Plate System
Summary page 1
…October 7, 2008 Predicate Device Stryker Spine Reflex® Hybrid ACP System (K0623 10, K040261) and Synthes Spine Cervical Spine Locking Plate System (K000536, K000742) Devic…
Stryker Spine20044
*K000536Synthes Anterior CSLP System
Summary page 1
…K0623 10, K040261) and Synthes Spine Cervical Spine Locking Plate System (K000536, K000742) Device Description This Special 510(k) premarket notification is intended to…
Synthes Spine20001
*K000742Synthes Anterior CSLP System
Summary page 1
…K040261) and Synthes Spine Cervical Spine Locking Plate System (K000536, K000742) Device Description This Special 510(k) premarket notification is intended to…
Synthes Spine2000—

Also cleared against K062310: 5 other devices →

What descends from it? (3)

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

NumberDeviceApplicantDecidedDescendants
K221728Aviator® Anterior Cervical Plating (ACP) System, LITe® Plate System, DynaTran™ Anterior…Stryker Corporation20221
K240592Wolff's Law Anterior Cervical Plate SystemSpinal Simplicity, LLC20240

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 9 years and passes through 3 companies; a new generation was cleared every 6.4 years on median.
  • 3 of the 4 ancestors have a recall of any class.
  • Of its descendants, K221728 (Stryker Corporation, 2022) has gone furthest, with 1 descendant of its own.
  • 5 other devices also cite its predicate K062310.

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. 2009, 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 Stryker Spine Reflex® Translational Cervical Plating (ACP) System is intended for use as an aid in cervical spinal fusion and is intended for unilateral fixation. The Reflex® Translational Anterior Cervical Plating System is intended for anterior intervertebral screw fixation of the cervical spine at levels C2-T1. The system is indicated for temporary stabilization of the anterior spine during the development of cervical spine fusions in patients…

Read the full statement (158 words)

The Stryker Spine Reflex® Translational Cervical Plating (ACP) System is intended for use as an aid in cervical spinal fusion and is intended for unilateral fixation.

The Reflex® Translational Anterior Cervical Plating System is intended for anterior intervertebral screw fixation of the cervical spine at levels C2-T1. The system is indicated for temporary stabilization of the anterior spine during the development of cervical spine fusions in patients with the following indications:

· 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

* Deformities or curvatures (including kyphosis, lordosis, or scoliosis)

* Pseudarthrosis

* Failed previous fusion

* Decompression of the spinal cord following total or partial cervical vertebrectomy

· Spondylolisthesis

* Spinal stenosis

WARNING: This device is not approved or intended for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.

Indications for use as stated in the FDA summary.

Also cleared against K062310

5 other devices cite the same predicate.

  • K221728Aviator® Anterior Cervical Plating (ACP) System, LITe® Plate System, DynaTran™ Anterior Cervical Plating…Stryker Corporation · 2022
  • K170342Ocata Anterior Cervical SystemKalitec Direct, LLC · 2017
  • K142237Aviator Anterior Cervical Plate (ACP) SystemStryker Corporation · 2015
  • K083562Stryker Spine Nulock Anterior Cervical Plating SystemStryker Corp. · 2009
  • K063430Zero Profile Anterior Cervical Plate (Acp) SystemStryker Spine · 2007

More from Stryker Corp.

156 FDA decisions under this applicant name. See the company

  • K230045HipCheckStryker Corp. · 2023
  • K191259Stryker CrossFlow Integrated Arthroscopy PumpStryker Corp. · 2019
  • K182359HipCheckStryker Corp. · 2018
  • P050044/S033Vitagel RT3 Sutgical HemostatStryker Corp. · 2017
  • P050044/S032Vitagel RT3 Surgical HemostatStryker Corp. · 2015

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/K083020 · printed Nov 5, 2026

Cite this page

510(k) Report. “K083020: Stryker Spine Reflex Translational Anterior Cervical Plating System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K083020

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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