510(k) Report

510(k) · Cleared

Cleared

Synthes Anterior Cervical Locking Plate (Aclp) System

K031276510(k) TraditionalCleared Jul 2, 200371-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 Jul 2, 2003 after a 71-day review. The FDA summary names no predicate by number. 128 later devices descend from it.

Decided
Jul 2, 2003
Review
71 days
Class
Class II
Product code
KWQ
Recalls
None
Predicates
0

128 later devices descend from it, 14 citing it directly.

Descendants, by year cleared 2016: 4 descendants cleared2004: 1 descendant cleared2014: 5 descendants cleared2011: 4 descendants cleared2017: 7 descendants cleared2021: 10 descendants cleared2005: 3 descendants cleared2019: 10 descendants cleared2018: 6 descendants cleared2012: 5 descendants cleared2013: 3 descendants cleared2023: 16 descendants cleared2015: 8 descendants cleared2020: 5 descendants cleared2022: 8 descendants cleared2025: 7 descendants cleared2006: 1 descendant cleared2007: 1 descendant cleared2026: 12 descendants cleared2008: 1 descendant cleared2024: 11 descendants cleared200020052010201520202025
  1. This deviceK031276 Synthes Anterior Cervical Locking Plate (Aclp) SystemSynthes (Usa) · 2003
  2. Descendant · cites it directly · 91 of its ownK033844 Synthes Anterior Cervical Compression SystemSynthes (Usa) · 2004
  3. Descendant · 2 generations on · 84 of its ownK050451 Synthes Vectra SystemSynthes Spine Co.Lp · 2005 · Recalled
  4. Descendant · 3 generations on · 49 of its ownK051665 Synthes Vectra-T SystemSynthes Spine · 2005 · Recalled
  5. Descendant · 3 generations on · 33 of its ownK112068 Synthes Zero-P Variable Angle (VA)Synthes Spine Co.Lp · 2011 · Recalled
  6. Descendant · 4 generations on · 30 of its ownK121852 Synthes Zero-P Variable Angle (VA)Synthes Spine Co.Lp · 2012

Showing 5 of 128 descendants. See all descendants

Descendants cleared per year

2004: 12005: 32006: 12007: 12008: 12011: 42012: 52013: 32014: 52015: 82016: 42017: 72018: 62019: 102020: 52021: 102022: 82023: 162024: 112025: 72026: 12
2004high 16 (2023) · low 0 (2009)2026

Most influential descendants

Showing 5 of 128 · See all
  • K033844Synthes Anterior Cervical Compression SystemSynthes (Usa) · 2004 · cites it directly91descendants
  • K050451Synthes Vectra SystemSynthes Spine Co.Lp · 2005 · 2 generations on84descendants
  • K051665Synthes Vectra-T SystemSynthes Spine · 2005 · 3 generations on49descendants
  • K112068Synthes Zero-P Variable Angle (VA)Synthes Spine Co.Lp · 2011 · 3 generations on33descendants
  • K121852Synthes Zero-P Variable Angle (VA)Synthes Spine Co.Lp · 2012 · 4 generations on30descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K031276Synthes Anterior Cervical Locking Plate (Aclp) SystemSynthes (Usa)2003—
+1K033844Synthes Anterior Cervical Compression SystemSynthes (Usa)2004—
+2K050451Synthes Vectra SystemSynthes Spine Co.Lp20053
+3K051665Synthes Vectra-T SystemSynthes Spine20052
+3K112068Synthes Zero-P Variable Angle (VA)Synthes Spine Co.Lp20111
+4K121852Synthes Zero-P Variable Angle (VA)Synthes Spine Co.Lp2012—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200410
200530
200610
200710
200810
201140
201250
201330
201450
201580
201640
201770
201860
2019100
202050
2021100
202280
2023160
2024110
202570
2026120
FIG. 1 — Lineage of K031276, 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? (128)

See all 128

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

NumberDeviceApplicantDecidedDescendants
K033844Synthes Anterior Cervical Compression SystemSynthes (Usa)200491
K113509Lexus Anterior Cervical Plate SystemL&K BIOMED Co., Ltd.201219
K151553Anterior Cervical Plate SystemOsteomed Implantes, Ltda201611
K161524Tangis Anterior Cervical PlateNvision Biomedical Technologies, LLC20168
K103137Venus Anterior Cervical PlateVerticor, Ltd.20115
K210424Quantum Anterior Cervical PlateNvision Biomedical Technologies, Inc.20214
K141500Optio-C Anterior Cervical SystemZimmer Spine, Inc.20142
K191786Cyclops™ Anterior Cervical Plate SystemDegen Medical, Inc.20191
K173867Axis Anterior Cervical Plate SystemAxis Orthopaedics20181
K131512Katia SystemShanghai Sanyou Medical Co, Ltd.20131

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, K033844 (Synthes (Usa), 2004) has gone furthest, with 91 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 ACLP System is intended for anterior screw fixation to the cervical spine (C2-C7) for the following indications: Degenerative Disc Disease (DDD), spondylolisthesis, trauma (including fractures), spinal stenosis and tumors (primary and metastatic), failed previous fusions, pseudoarthosis, and deformity (defined as kyphosis, lordosis and scoliosis).

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/K031276 · printed Nov 5, 2026

Cite this page

510(k) Report. “K031276: Synthes Anterior Cervical Locking Plate (Aclp) System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K031276

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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