510(k) Report

510(k) · Cleared

Recalled · Class II · 2016

Synthes Anterior CSLP System

K000536510(k) SpecialCleared Mar 15, 200028-day reviewClass II21 CFR 888.3060Recalls 1

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 15, 2000 after a 28-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 297 later devices descend from it. It has been recalled once.

Decided
Mar 15, 2000
Review
28 days
Class
Class II
Product code
KWQ
Recalls
1
Predicates
0

297 later devices descend from it, 40 citing it directly.

Descendants, by year cleared 2018: 16 descendants cleared2006: 3 descendants cleared2016: 6 descendants cleared2010: 7 descendants cleared2011: 7 descendants cleared2007: 3 descendants cleared2004: 1 descendant cleared2013: 10 descendants cleared2009: 5 descendants cleared2015: 18 descendants cleared2017: 15 descendants cleared2019: 15 descendants cleared2005: 3 descendants cleared2014: 2 descendants cleared2012: 5 descendants cleared2008: 5 descendants cleared2022: 15 descendants cleared2024: 32 descendants cleared2020: 16 descendants cleared2021: 15 descendants cleared2023: 32 descendants cleared2025: 36 descendants cleared2026: 30 descendants cleared200020052010201520202025
  1. This deviceK000536 Synthes Anterior CSLP SystemSynthes Spine · 2000
  2. Descendant · cites it directly · 97 of its ownK131025 Archon Anterior Cervical Plate SystemNuvasive, Inc. · 2013
  3. Descendant · 2 generations on · 94 of its ownK161442 NuVasive® CoRoent® Small Interlock™ SystemNu Vasive, Incorporated · 2016
  4. Descendant · 3 generations on · 83 of its ownK173115 COALITION® and COALITION® TPS, COALITION MIS® and COALITION MIS®…Globus Medical, Inc. · 2017
  5. Descendant · cites it directly · 62 of its ownK070681 Next Generation Anterior Cervical Plating SystemAlphatec Spine, Inc. · 2007 · Recalled
  6. Descendant · 2 generations on · 38 of its ownK102820 Appliance, Fixation, Spinal Intervertebral BodyAlphatec Spine, Inc. · 2010 · Recalled

Showing 5 of 297 descendants. See all descendants

Descendants cleared per year

2004: 12005: 32006: 32007: 32008: 52009: 52010: 72011: 72012: 52013: 102014: 22015: 182016: 62017: 152018: 162019: 152020: 162021: 152022: 152023: 322024: 322025: 362026: 30
2004high 36 (2025) · low 1 (2004)2026

Most influential descendants

Showing 5 of 297 · See all
  • K131025Archon Anterior Cervical Plate SystemNuvasive, Inc. · 2013 · cites it directly97descendants
  • K161442NuVasive® CoRoent® Small Interlock™ SystemNu Vasive, Incorporated · 2016 · 2 generations on94descendants
  • K173115COALITION® and COALITION® TPS, COALITION MIS® and COALITION MIS® TPS, COALITION AGX® and…Globus Medical, Inc. · 2017 · 3 generations on83descendants
  • K070681Next Generation Anterior Cervical Plating SystemAlphatec Spine, Inc. · 2007 · cites it directly62descendants
  • K102820Appliance, Fixation, Spinal Intervertebral BodyAlphatec Spine, Inc. · 2010 · 2 generations on38descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K000536Synthes Anterior CSLP SystemSynthes Spine2000—
+1K131025Archon Anterior Cervical Plate SystemNuvasive, Inc.2013—
+2K161442NuVasive® CoRoent® Small Interlock™ SystemNu Vasive, Incorporated2016—
+3K173115COALITION® and COALITION® TPS, COALITION MIS® and COALITION MIS® TPS…Globus Medical, Inc.2017—
+1K070681Next Generation Anterior Cervical Plating SystemAlphatec Spine, Inc.20071
+2K102820Appliance, Fixation, Spinal Intervertebral BodyAlphatec Spine, Inc.20102

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200410
200530
200630
200730
200850
200950
201070
201170
201250
2013100
201420
2015180
201660
2017150
2018160
2019150
2020160
2021150
2022150
2023320
2024320
2025360
2026300
FIG. 1 — Lineage of K000536, 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), 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? (297)

See all 297

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

NumberDeviceApplicantDecidedDescendants
K131025Archon Anterior Cervical Plate SystemNuvasive, Inc.201397
K070681Next Generation Anterior Cervical Plating SystemAlphatec Spine, Inc.200762
K100265Diamond Anterior Cervical Plate SystemAmendia, Inc.201034
K043066Pioneer Anterior Cervical Plate SystemPioneer Surgical Technology200527
K062310Reflex Hybrid Acp SystemStryker Spine200622
K150417Astra Spine SystemSpinecraft, LLC201521
K083562Stryker Spine Nulock Anterior Cervical Plating SystemStryker Corp.200916
K083338Cardiff Anterior Cervical Plate SystemSeaspine, Inc.200916
K131810Osseus Black Diamond Pedicle Screw SystemOsseus Fusion Systems, LLC201314
K151553Anterior Cervical Plate SystemOsteomed Implantes, Ltda201611

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

Recalls of this device

DateClassRecallRoot causeReason
Jan 6, 2016Class IIZ-1524-2016Packaging process controlDePuy Synthes is initiating a Voluntary Medical Device Recall of lot # 9666776 and 9671879 of Cancellous and Cortex 4.0 mm Screws, which are a part of the Cervical Spine Locking Plate (CSLP) System due to discovery of a single lot of…

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K131025 (Nuvasive, Inc., 2013) has gone furthest, with 97 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

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  • K120838Synthes Matrix SystemSynthes Spine · 2012
  • K111048Synthes Scout Tack FixationSynthes Spine · 2012
  • K120928Synthes Matrix SystemSynthes Spine · 2012
  • K120571Synthes Uss ConnectorSynthes Spine · 2012

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The KWQ category page

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https://510kreport.com/device/K000536 · printed Nov 6, 2026

Cite this page

510(k) Report. “K000536: 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/K000536

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026