510(k) Report

FDA product code · Orthopedic

Appliance, Fixation, Spinal Intervertebral Body

KWQClass II21 CFR 888.3060510(k) required668 decisions since 1979129 recalls

668 FDA decisions since 1979. 510(k) reviews decided 2021–2025 took a median of 64 days (half between 49 and 110). 129 recalls name this code, 0 of them Class I. The most-cited predicate is K030866, named by 42 later devices.

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

FIG. A — Illustration, orthopedic panel

Twenty years of KWQ at a glance: how often FDA decides these devices, how long 510(k) reviews take, how often they are recalled, and how many adverse event reports name the code.

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—
FIG. 1 — KWQ by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in KWQ? A 510(k) Report ranks candidate predicates in this code by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which predicates do KWQ devices cite most?

Devices in this code that later submissions most often claim equivalence to.

  • K030866Synthes Anterior CSLP SystemSynthes (Usa) · 200342cite it
  • K000536Synthes Anterior CSLP SystemSynthes Spine · 200040cite it
  • K042025Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 200437cite it
  • K042544Uniplate Anterior Cervical Plate SystemDepuy Spine, Inc. · 200426cite it
  • K945700Synthes (Usa) Anterior Cervical Vertebrae Plate SystemSynthes (Usa) · 199524cite it
  • K992168Moss Miami 6.35MM Polyaxial ScrewDepuyacromed · 199922cite it

Which KWQ devices have the deepest lineage?

Devices in this code with the longest line of descent behind them.

  • K251965Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)Alphatec Spine, Inc. · 202532generations
  • K233640Segmental Plating System (SPS);IdentiTi SPS Interbody System;IdentiTi NanoTec SPS Interbody System…Alphatec Spine, Inc. · 202431generations
  • K230721ATEC Lateral Plate SystemAlphatec Spine, Inc. · 202331generations
  • K250486Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI) · 202527generations
  • K232256Alcantara Thoracolumbar Plate SystemCamber Spine Technologies, LLC · 202427generations
  • K243015Skyway Anterior Cervical Plate SystemKyocera Medical Technologies, Inc. · 202426generations

What has FDA decided in KWQ lately?

  • 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
  • K260697VyPlate™ Anterior Cervical Plate SystemVy Spine, LLC · 2026

All 668 KWQ decisions →

What has been recalled in KWQ lately?

  • K150896Vitality Spinal Fixation System.Spinal Intervertebral Body, Appliance, Fixation…Zimmer Biomet Spine Inc. · Jul 30, 2018Class II
  • K153042TRYPTIK (R) 2 C-PLATE SELF-TAPPING POLYAXIAL SCREW 4.0 MM, LENGTH 16 MM, REF TRY-PS-40…SPINEART SA route de Pre bois 20 Case Postale · Nov 27, 2017Class II
  • K153042TRYPTIK (R) 2 C-PLATE SELF-TAPPING POLYAXIAL SCREW 4.0 MM, LENGTH 12 MM, REF TRY-PS-40…SPINEART SA route de Pre bois 20 Case Postale · Nov 27, 2017Class II
  • K153042TRYPTIK (R) 2 C-PLATE SELF-TAPPING POLYAXIAL SCREW 4.0 MM, LENGTH 14 MM, REF TRY-PS-40…SPINEART SA route de Pre bois 20 Case Postale · Nov 27, 2017Class II
  • K153042TRYPTIK (R) 2 C-PLATE SELF-TAPPING POLYAXIAL SCREW 4.5 MM, LENGTH 16 MM, REF TRY-PS-45…SPINEART SA route de Pre bois 20 Case Postale · Nov 27, 2017Class II
  • K153042TRYPTIK (R) 2 C-PLATE SELF-TAPPING POLYAXIAL SCREW 4.5 MM, LENGTH 14 MM, REF TRY-PS-45…SPINEART SA route de Pre bois 20 Case Postale · Nov 27, 2017Class II

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