510(k) Report

510(k) · Cleared

Recalled · 2009

Reflex Hybrid Acp System

K062310510(k) SpecialCleared Aug 18, 200610-day reviewClass II21 CFR 888.3060Recalls 2

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Stryker Spine · KWQ Appliance, Fixation, Spinal Intervertebral Body

Cleared on Aug 18, 2006 as substantially equivalent to K040261 (Stryker Spine, 2004) and 2 other predicates after a 10-day review. Its family tree reaches back 1 generation to 2000. 22 later devices descend from it. It has been recalled 2 times.

Decided
Aug 18, 2006
Review
10 days
Class
Class II
Product code
KWQ
Recalls
2
Predicates
3

Its longest line of descent runs back 1 generation to K000536 (2000). 3 ancestors in all. 22 later devices descend from it, 6 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2004: 1 other ancestor2000: 1 other ancestor2007: 1 descendant cleared2022: 2 descendants cleared2009: 2 descendants cleared2017: 2 descendants cleared2015: 3 descendants cleared2024: 4 descendants cleared2019: 2 descendants cleared2018: 3 descendants cleared2023: 1 descendant cleared2025: 1 descendant cleared2026: 1 descendant clearedK000536 · Synthes Anterior CSLP System · Synthes Spine · 2000 · recalled200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors 1 generation forward: 6 descendants2 generations forward: 8 descendants3 generations forward: 6 descendants4 generations forward: 1 descendant5 generations forward: 1 descendant K000536 · Synthes Anterior CSLP System · Synthes Spine · 2000 · recalled0+5
  1. Root · 1 generation backK000536 Synthes Anterior CSLP SystemSynthes Spine · 2000 · Recalled
  2. This deviceK062310 Reflex Hybrid Acp SystemStryker Spine · 2006
  3. Descendant · cites it directly · 16 of its ownK083562 Stryker Spine Nulock Anterior Cervical Plating SystemStryker Corp. · 2009
  4. Descendant · cites it directly · 9 of its ownK142237 Aviator Anterior Cervical Plate (ACP) SystemStryker Corporation · 2015
  5. Descendant · 2 generations on · 4 of its ownK190227 Boomerang™ Anterior Cervical Plate SystemChoicespine, LP · 2019
  6. Descendant · 2 generations on · 4 of its ownK150759 Hyper-C Anterior Cervical Plate SystemDegen Medical · 2015
  7. Descendant · cites it directly · 3 of its ownK083020 Stryker Spine Reflex Translational Anterior Cervical Plating SystemStryker Corp. · 2009

Showing 5 of 22 descendants. See all descendants

Descendants cleared per year

2007: 12009: 22015: 32017: 22018: 32019: 22022: 22023: 12024: 42025: 12026: 1
2007high 4 (2024) · low 0 (2008)2026

Most influential descendants

Showing 5 of 22 · See all
  • K083562Stryker Spine Nulock Anterior Cervical Plating SystemStryker Corp. · 2009 · cites it directly16descendants
  • K142237Aviator Anterior Cervical Plate (ACP) SystemStryker Corporation · 2015 · cites it directly9descendants
  • K190227Boomerang™ Anterior Cervical Plate SystemChoicespine, LP · 2019 · 2 generations on4descendants
  • K150759Hyper-C Anterior Cervical Plate SystemDegen Medical · 2015 · 2 generations on4descendants
  • K083020Stryker Spine Reflex Translational Anterior Cervical Plating SystemStryker Corp. · 2009 · cites it directly3descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K000536Synthes Anterior CSLP SystemSynthes Spine20001
0 (this device)K062310Reflex Hybrid Acp SystemStryker Spine2006—
+1K083562Stryker Spine Nulock Anterior Cervical Plating SystemStryker Corp.2009—
+1K142237Aviator Anterior Cervical Plate (ACP) SystemStryker Corporation2015—
+2K190227Boomerang™ Anterior Cervical Plate SystemChoicespine, LP2019—
+2K150759Hyper-C Anterior Cervical Plate SystemDegen Medical2015—
+1K083020Stryker Spine Reflex Translational Anterior Cervical Plating SystemStryker Corp.2009—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200010
200410

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200710
200920
201530
201720
201830
201920
202220
202310
202440
202510
202610
FIG. 1 — Lineage of K062310, 2000–2026Source: 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
Get a 510(k) Report

What was it cleared against? (3)

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
*K040261Reflex Hybrid Anterior Cervical Plate System
Summary page 1
…ckdstryker.com Date Summary Prepared: August 7, 2006 Predicate Device RefleXTm Hybrid ACP System (K04026 1) Synthes Cervical Spine Locking Plate System…
Stryker Spine20044
*K000536Synthes Anterior CSLP System
Summary page 1
…ystem (K04026 1) Synthes Cervical Spine Locking Plate System (K000536 and K000742) Line Extension to the Stryker Spine Reflex Tm hybrid ACP System Special 510(k) Pr…
Synthes Spine20001
*K000742Synthes Anterior CSLP System
Summary page 1
…6 1) Synthes Cervical Spine Locking Plate System (K000536 and K000742) Line Extension to the Stryker Spine Reflex Tm hybrid ACP System Special 510(k) Premarket Noti…
Synthes Spine2000—

Also cleared against K040261: 8 other devices →

What descends from it? (22)

See all 22

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

NumberDeviceApplicantDecidedDescendants
K083562Stryker Spine Nulock Anterior Cervical Plating SystemStryker Corp.200916
K142237Aviator Anterior Cervical Plate (ACP) SystemStryker Corporation20159
K083020Stryker Spine Reflex Translational Anterior Cervical Plating SystemStryker Corp.20093
K063430Zero Profile Anterior Cervical Plate (Acp) SystemStryker Spine20072
K221728Aviator® Anterior Cervical Plating (ACP) System, LITe® Plate System, DynaTran™ Anterior…Stryker Corporation20221
K170342Ocata Anterior Cervical SystemKalitec Direct, LLC20171

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Oct 12, 2009Not classifiedZ-0763-2010Employee errorThe threaded tip of the Reflex Hybrid Screw Extractor has been found to fracture the head of the screw, causing problems in removing the screw and possible damage to the screw and/or plate while attempting to remove the screw.
Oct 12, 2009Not classifiedZ-0762-2010Employee errorThe threaded tip of the Reflex Hybrid Screw Extractor has been found to fracture the head of the screw, causing problems in removing the screw and possible damage to the screw and/or plate while attempting to remove the screw.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • 2 of the 3 ancestors have a recall of any class.
  • Of its descendants, K083562 (Stryker Corp., 2009) has gone furthest, with 16 descendants of its own.
  • 8 other devices also cite its predicate K040261.

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 Reflex TM Hybrid ACP 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 history and radiographic studies) Trauma…

Read the full statement (97 words)

The Reflex TM Hybrid ACP 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 history and radiographic studies)

Trauma (including fractures)

Tumors

Deformities or curvatures (including kyphosis, lordosis or scoliosis)

Pseudoarthrosis

Failed previous fusion

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

Spondylolisthesis

Spinal Stenosis

Indications for use as stated in the FDA summary.

Also cleared against K040261

8 other devices cite the same predicate.

  • K200883CarboClear® Cervical Plate SystemCarboFix Orthopedics, Ltd. · 2020
  • K170342Ocata Anterior Cervical SystemKalitec Direct, LLC · 2017
  • K142237Aviator Anterior Cervical Plate (ACP) SystemStryker Corporation · 2015
  • K100215Archimed Remedy Cervical PlateArchimed, Inc. · 2010
  • K083020Stryker Spine Reflex Translational Anterior Cervical Plating SystemStryker Corp. · 2009
  • K083562Stryker Spine Nulock Anterior Cervical Plating SystemStryker Corp. · 2009

More from Stryker Spine

92 FDA decisions under this applicant name. See the company

  • K262061Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior Lumbar Cage; Aero®…Stryker Spine · 2026
  • K261008Vitoss® BiModal Bioactive Bone Graft Substitute Foam Strip; Vitoss® BiModal Bioactive Bone Graft Substitute…Stryker Spine · 2026
  • K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System; MESA® Spinal System…Stryker Spine · 2024
  • K242280Vitoss® BiModal Bioactive Bone Graft Substitute Foam Strip, Vitoss® BiModal Bioactive Bone Graft Substitute…Stryker Spine · 2024
  • K222684XIA® 4.5 Spinal System, XIA® 4.5 Cortical Trajectory, XIA® 3 Spinal System, Serrato® Spinal System, XIA®…Stryker Spine · 2023

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The KWQ category page

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https://510kreport.com/device/K062310 · printed Nov 6, 2026

Cite this page

510(k) Report. “K062310: Reflex Hybrid Acp System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K062310

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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