510(k) Report

510(k) · Cleared

Cleared

Synthes Anterior CSLP System

K000742510(k) SpecialCleared Mar 29, 200022-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

Synthes Spine · KWQ Appliance, Fixation, Spinal Intervertebral Body

Cleared on Mar 29, 2000 after a 22-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 75 later devices descend from it.

Decided
Mar 29, 2000
Review
22 days
Class
Class II
Product code
KWQ
Recalls
None
Predicates
0

75 later devices descend from it, 16 citing it directly.

Descendants, by year cleared 2017: 7 descendants cleared2016: 2 descendants cleared2007: 1 descendant cleared2004: 1 descendant cleared2009: 2 descendants cleared2019: 5 descendants cleared2024: 10 descendants cleared2012: 3 descendants cleared2015: 4 descendants cleared2006: 1 descendant cleared2001: 1 descendant cleared2014: 1 descendant cleared2008: 1 descendant cleared2022: 6 descendants cleared2013: 1 descendant cleared2018: 3 descendants cleared2021: 3 descendants cleared2023: 7 descendants cleared2020: 3 descendants cleared2025: 6 descendants cleared2026: 7 descendants cleared200020052010201520202025
  1. This deviceK000742 Synthes Anterior CSLP SystemSynthes Spine · 2000
  2. Descendant · cites it directly · 22 of its ownK062310 Reflex Hybrid Acp SystemStryker Spine · 2006 · Recalled
  3. Descendant · cites it directly · 21 of its ownK121514 Anodyne Anterior Cervical Plate SystemCorelink, LLC · 2012
  4. Descendant · 2 generations on · 18 of its ownK163104 Terrace™ Anterior Cervical Plate SystemCorelink, LLC · 2017
  5. Descendant · cites it directly · 16 of its ownK083562 Stryker Spine Nulock Anterior Cervical Plating SystemStryker Corp. · 2009
  6. Descendant · 3 generations on · 15 of its ownK190016 Lateral Plate SystemCorelink, LLC · 2019

Showing 5 of 75 descendants. See all descendants

Descendants cleared per year

2001: 12004: 12006: 12007: 12008: 12009: 22012: 32013: 12014: 12015: 42016: 22017: 72018: 32019: 52020: 32021: 32022: 62023: 72024: 102025: 62026: 7
2001high 10 (2024) · low 0 (2002)2026

Most influential descendants

Showing 5 of 75 · See all
  • K062310Reflex Hybrid Acp SystemStryker Spine · 2006 · cites it directly22descendants
  • K121514Anodyne Anterior Cervical Plate SystemCorelink, LLC · 2012 · cites it directly21descendants
  • K163104Terrace™ Anterior Cervical Plate SystemCorelink, LLC · 2017 · 2 generations on18descendants
  • K083562Stryker Spine Nulock Anterior Cervical Plating SystemStryker Corp. · 2009 · cites it directly16descendants
  • K190016Lateral Plate SystemCorelink, LLC · 2019 · 3 generations on15descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K000742Synthes Anterior CSLP SystemSynthes Spine2000—
+1K062310Reflex Hybrid Acp SystemStryker Spine20062
+1K121514Anodyne Anterior Cervical Plate SystemCorelink, LLC2012—
+2K163104Terrace™ Anterior Cervical Plate SystemCorelink, LLC2017—
+1K083562Stryker Spine Nulock Anterior Cervical Plating SystemStryker Corp.2009—
+3K190016Lateral Plate SystemCorelink, LLC2019—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200110
200410
200610
200710
200810
200920
201230
201310
201410
201540
201620
201770
201830
201950
202030
202130
202260
202370
2024100
202560
202670
FIG. 1 — Lineage of K000742, 2000–2026Source: 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), 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?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (75)

See all 75

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

NumberDeviceApplicantDecidedDescendants
K062310Reflex Hybrid Acp SystemStryker Spine200622
K121514Anodyne Anterior Cervical Plate SystemCorelink, LLC201221
K083562Stryker Spine Nulock Anterior Cervical Plating SystemStryker Corp.200916
K151553Anterior Cervical Plate SystemOsteomed Implantes, Ltda201611
K142237Aviator Anterior Cervical Plate (ACP) SystemStryker Corporation20159
K173099Fortis and Hana Anterior Cervical Plate SystemHuvexel Co., Ltd.20174
K012881C3 Anterior Cervical Plate SystemSpine Vision, Inc.20014
K083020Stryker Spine Reflex Translational Anterior Cervical Plating SystemStryker Corp.20093
K190666CYGNUS™ Anterior Cervical Plate SystemMiRus, LLC20192
K112809Blue Mountain Cervical PlateQualgenix, LLC20122

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?

  • Of its descendants, K062310 (Stryker Spine, 2006) has gone furthest, with 22 descendants of its own.

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—

More from Synthes Spine

36 FDA decisions under this applicant name. See the company

  • K122211Synthes Navigable Pedicle Preparation InstrumentsSynthes Spine · 2012
  • K120838Synthes Matrix SystemSynthes Spine · 2012
  • K111048Synthes Scout Tack FixationSynthes Spine · 2012
  • K120928Synthes Matrix SystemSynthes Spine · 2012
  • K120571Synthes Uss ConnectorSynthes Spine · 2012

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/K000742 · printed Nov 6, 2026

Cite this page

510(k) Report. “K000742: Synthes Anterior CSLP System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K000742

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
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026