510(k) Report

510(k) · Cleared

Cleared

Synthes Anterior CSLP System

K030866510(k) TraditionalCleared Apr 18, 200330-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 (Usa) · KWQ Appliance, Fixation, Spinal Intervertebral Body

Cleared on Apr 18, 2003 after a 30-day review. The FDA summary names no predicate by number. 339 later devices descend from it.

Decided
Apr 18, 2003
Review
30 days
Class
Class II
Product code
KWQ
Recalls
None
Predicates
0

339 later devices descend from it, 42 citing it directly.

Descendants, by year cleared 2012: 7 descendants cleared2010: 4 descendants cleared2008: 3 descendants cleared2017: 14 descendants cleared2016: 12 descendants cleared2019: 16 descendants cleared2014: 8 descendants cleared2011: 6 descendants cleared2024: 41 descendants cleared2004: 2 descendants cleared2005: 2 descendants cleared2020: 23 descendants cleared2006: 1 descendant cleared2015: 9 descendants cleared2007: 3 descendants cleared2018: 11 descendants cleared2009: 2 descendants cleared2023: 41 descendants cleared2013: 2 descendants cleared2022: 32 descendants cleared2021: 28 descendants cleared2025: 39 descendants cleared2026: 33 descendants cleared200020052010201520202025
  1. This deviceK030866 Synthes Anterior CSLP SystemSynthes (Usa) · 2003
  2. Descendant · cites it directly · 178 of its ownK040721 Assure Anterior Cervical Plate SystemGlobus Medical, Inc. · 2004
  3. Descendant · 2 generations on · 177 of its ownK070775 Modification to: Providence Anterior Cervical Plate SystemGlobus Medical, Inc. · 2007
  4. Descendant · 2 generations on · 171 of its ownK081391 Vip Anterior Cervical Plate SystemGlobus Medical, Inc. · 2008
  5. Descendant · 3 generations on · 155 of its ownK142218 Coalition AGX Plate and Coalition AGX SpacerGlobus Medical, Inc. · 2015
  6. Descendant · 4 generations on · 149 of its ownK152022 SUSTAIN® R Spacers, PATRIOT® Spacers, CALIBER® Spacers, RISE®…Globus Medical, Inc. · 2017

Showing 5 of 339 descendants. See all descendants

Descendants cleared per year

2004: 22005: 22006: 12007: 32008: 32009: 22010: 42011: 62012: 72013: 22014: 82015: 92016: 122017: 142018: 112019: 162020: 232021: 282022: 322023: 412024: 412025: 392026: 33
2004high 41 (2023) · low 1 (2006)2026

Most influential descendants

Showing 5 of 339 · See all
  • K040721Assure Anterior Cervical Plate SystemGlobus Medical, Inc. · 2004 · cites it directly178descendants
  • K070775Modification to: Providence Anterior Cervical Plate SystemGlobus Medical, Inc. · 2007 · 2 generations on177descendants
  • K081391Vip Anterior Cervical Plate SystemGlobus Medical, Inc. · 2008 · 2 generations on171descendants
  • K142218Coalition AGX Plate and Coalition AGX SpacerGlobus Medical, Inc. · 2015 · 3 generations on155descendants
  • K152022SUSTAIN® R Spacers, PATRIOT® Spacers, CALIBER® Spacers, RISE® Spacers, COALITION®…Globus Medical, Inc. · 2017 · 4 generations on149descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K030866Synthes Anterior CSLP SystemSynthes (Usa)2003—
+1K040721Assure Anterior Cervical Plate SystemGlobus Medical, Inc.2004—
+2K070775Modification to: Providence Anterior Cervical Plate SystemGlobus Medical, Inc.2007—
+2K081391Vip Anterior Cervical Plate SystemGlobus Medical, Inc.2008—
+3K142218Coalition AGX Plate and Coalition AGX SpacerGlobus Medical, Inc.2015—
+4K152022SUSTAIN® R Spacers, PATRIOT® Spacers, CALIBER® Spacers, RISE® Spacers…Globus Medical, Inc.2017—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200420
200520
200610
200730
200830
200920
201040
201160
201270
201320
201480
201590
2016120
2017140
2018110
2019160
2020230
2021280
2022320
2023410
2024410
2025390
2026330
FIG. 1 — Lineage of K030866, 2003–2026Source: 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?

The FDA summary names no predicate by number.

What descends from it? (339)

See all 339

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

NumberDeviceApplicantDecidedDescendants
K040721Assure Anterior Cervical Plate SystemGlobus Medical, Inc.2004178
K051665Synthes Vectra-T SystemSynthes Spine200549
K120515Tempus Cervical Plate SystemNeurostructures, LLC201223
K141632Zevo (TM) Anterior Cervical Plate SystemMedtronic Sofamor Danek USA, Inc.201418
K111796Invizia Anterior Cervical Plate SystemZimmer Spine, Inc.201118
K073232Indus Anterior Cervical Plate System, Model IM3XXXSpinefrontier, Inc.200817
K093776Indus Anterior Cervical Plate SystemSpinefrontier, Inc.201016
K050588Verteview Anterior Cervical Plate SystemInnovative Spinal Design, LLC200516
K121060Spine Frontier Indus Acp SystemSpinefrontier, Inc.201215
K151553Anterior Cervical Plate SystemOsteomed Implantes, Ltda201611

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, K040721 (Globus Medical, Inc., 2004) has gone furthest, with 178 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—

What is it indicated for?

The Synthes Anterior CSLP System is intended for anterior screw fixation to the cervical spine (C2-C7) for the following indications:

1. Spondylolisthesis

2. Fracture

3. Spinal stenosis

4. Tumor

5. Degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies).

Indications for use as stated in the FDA summary.

More from Synthes (Usa)

406 FDA decisions under this applicant name. See the company

  • K131984Synthes Synsonic Ulna NailSynthes (Usa) · 2014
  • K111667Synthes Suprapatellar Insertion InstrumentsSynthes (Usa) · 20111 recall
  • K111540Synthes 3.5MM LCP Clavicle Plate SystemSynthes (Usa) · 2011
  • K110789Synthes Sternal Zipfix SystemSynthes (Usa) · 20113 recalls
  • K103002Synthes Multiloc Proximal Humeral Nailing SystemSynthes (Usa) · 20112 recalls

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/K030866 · printed Nov 6, 2026

Cite this page

510(k) Report. “K030866: 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/K030866

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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