510(k) Report

510(k) · Cleared

Cleared

Lexus Anterior Cervical Plate System

K113509510(k) TraditionalCleared Jan 20, 201253-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

L&K BIOMED Co., Ltd. · KWQ Appliance, Fixation, Spinal Intervertebral Body

Cleared on Jan 20, 2012 as substantially equivalent to K061002 (U&I Corp., 2006) and 3 other predicates after a 53-day review. Its family tree reaches back 2 generations to 2000. 19 later devices descend from it.

Decided
Jan 20, 2012
Review
53 days
Class
Class II
Product code
KWQ
Recalls
None
Predicates
4

Its longest line of descent runs back 2 generations to K994239 (2000). 4 ancestors in all. 19 later devices descend from it, 4 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2003: 2 other ancestors2023: 6 descendants cleared2015: 2 descendants cleared2012: 1 descendant cleared2019: 3 descendants cleared2026: 2 descendants cleared2021: 3 descendants cleared2022: 1 descendant cleared2024: 1 descendant clearedK994239 · Zephir Anterior Cervical Plate System · Medtronic Sofamor Danek, Inc. · 2000K061002 · Maxima Anterior Cervical Plate System · U&I Corp. · 2006200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors 1 generation forward: 4 descendants2 generations forward: 6 descendants3 generations forward: 2 descendants4 generations forward: 5 descendants5 generations forward: 2 descendants K061002 · Maxima Anterior Cervical Plate System · U&I Corp. · 2006K994239 · Zephir Anterior Cervical Plate System · Medtronic Sofamor Danek, Inc. · 20000+5
  1. Root · 2 generations backK994239 Zephir Anterior Cervical Plate SystemMedtronic Sofamor Danek, Inc. · 2000
  2. 1 generation backK061002 Maxima Anterior Cervical Plate SystemU&I Corp. · 2006
  3. This deviceK113509 Lexus Anterior Cervical Plate SystemL&K BIOMED Co., Ltd. · 2012
  4. Descendant · cites it directly · 15 of its ownK143271 CastleLoc-P Anterior Cervical Plate SystemL&K BIOMED Co., Ltd. · 2015
  5. Descendant · 2 generations on · 13 of its ownK190425 CastleLoc-P Anterior Cervical Plate SystemL&K BIOMED Co., Ltd. · 2019
  6. Descendant · 3 generations on · 10 of its ownK210035 ZESPIN SI Joint Fusion System, MegaCerfix Posterior Cervical…Aegis Spine · 2021
  7. Descendant · 4 generations on · 6 of its ownK221050 ZESPIN SI Joint Fusion System, Paeon Posterior Cervical Fixation…Aegis Spine, Inc. · 2022
  8. Descendant · cites it directly · 5 of its ownK143279 LnK Anterior Cervical Plate SystemL&K BIOMED Co., Ltd. · 2015

Showing 5 of 19 descendants. See all descendants

Descendants cleared per year

2012: 12015: 22019: 32021: 32022: 12023: 62024: 12026: 2
2012high 6 (2023) · low 0 (2013)2026

Most influential descendants

Showing 5 of 19 · See all
  • K143271CastleLoc-P Anterior Cervical Plate SystemL&K BIOMED Co., Ltd. · 2015 · cites it directly15descendants
  • K190425CastleLoc-P Anterior Cervical Plate SystemL&K BIOMED Co., Ltd. · 2019 · 2 generations on13descendants
  • K210035ZESPIN SI Joint Fusion System, MegaCerfix Posterior Cervical Fixation System, MegaCerfix…Aegis Spine · 2021 · 3 generations on10descendants
  • K221050ZESPIN SI Joint Fusion System, Paeon Posterior Cervical Fixation System, Paeon Anterior…Aegis Spine, Inc. · 2022 · 4 generations on6descendants
  • K143279LnK Anterior Cervical Plate SystemL&K BIOMED Co., Ltd. · 2015 · cites it directly5descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K994239Zephir Anterior Cervical Plate SystemMedtronic Sofamor Danek, Inc.2000—
−1K061002Maxima Anterior Cervical Plate SystemU&I Corp.2006—
0 (this device)K113509Lexus Anterior Cervical Plate SystemL&K BIOMED Co., Ltd.2012—
+1K143271CastleLoc-P Anterior Cervical Plate SystemL&K BIOMED Co., Ltd.2015—
+2K190425CastleLoc-P Anterior Cervical Plate SystemL&K BIOMED Co., Ltd.2019—
+3K210035ZESPIN SI Joint Fusion System, MegaCerfix Posterior Cervical Fixation System…Aegis Spine2021—
+4K221050ZESPIN SI Joint Fusion System, Paeon Posterior Cervical Fixation System, Paeon…Aegis Spine, Inc.2022—
+1K143279LnK Anterior Cervical Plate SystemL&K BIOMED Co., Ltd.2015—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200320

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201210
201520
201930
202130
202210
202360
202410
202620
FIG. 1 — Lineage of K113509, 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), 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? (4)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*K061002Maxima Anterior Cervical Plate System
Summary page 1
…KWQ Device Classification Class 11 3. Identification of Legally Marketed Devices " U&I Corporation: Maxima~m Anterior Cervical Plate System (K061002) * Synthes: Synthes Anterior Cervical Locking Plate(ACLP) System (K03 1276) * Medtronic: ZEPH IR~ Anterior Cervical P…
U&I Corp.2006—
*K031276Synthes Anterior Cervical Locking Plate (Aclp) System
Summary page 1
…egally Marketed Devices " U&I Corporation: Maxima~m Anterior Cervical Plate System (K061002) * Synthes: Synthes Anterior Cervical Locking Plate(ACLP) System (K03 1276) * Medtronic: ZEPH IR~ Anterior Cervical Plate System (K99423 9, K0303 27) 4. Description of the Device The LEXUS…
Synthes (Usa)2003—
*K994239Zephir Anterior Cervical Plate System
Summary page 1
…vical Plate System (K061002) * Synthes: Synthes Anterior Cervical Locking Plate(ACLP) System (K03 1276) * Medtronic: ZEPH IR~ Anterior Cervical Plate System (K99423 9, K0303 27) 4. Description of the Device The LEXUS Anterior Cervical Plate System is composed of plates and screws…
Medtronic Sofamor Danek, Inc.2000—
*K030327Zephir Anterior Cervical System
Summary page 1
…e System (K061002) * Synthes: Synthes Anterior Cervical Locking Plate(ACLP) System (K03 1276) * Medtronic: ZEPH IR~ Anterior Cervical Plate System (K99423 9, K0303 27) 4. Description of the Device The LEXUS Anterior Cervical Plate System is composed of plates and screws which are…
Medtronic Sofamor Danek2003—

Also cleared against K061002: 5 other devices →

What descends from it? (19)

See all 19

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

NumberDeviceApplicantDecidedDescendants
K143271CastleLoc-P Anterior Cervical Plate SystemL&K BIOMED Co., Ltd.201515
K143279LnK Anterior Cervical Plate SystemL&K BIOMED Co., Ltd.20155
K231839CastleLoc-P Anterior Cervical Plate System, AccelFix Lumbar Plate SystemL&K BIOMED Co., Ltd.20232
K121078Van Gogh Anterior Cervical Plate SystemAccel Spine20120

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?

  • The line of descent spans 12 years and passes through 3 companies; a new generation was cleared every 6.4 years on median.
  • None of the 4 ancestors has a recall.
  • Of its descendants, K143271 (L&K BIOMED Co., Ltd., 2015) has gone furthest, with 15 descendants of its own.
  • 5 other devices also cite its predicate K061002.

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. 2012, this device’s year, is highlighted.

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 LEXUS Anterior Cervical Plate System is intended for anterior screw fixation to the cervical spine (C2-C7). The System is indicated for use in the immobilization and stabilization of the spine as an adjunct to fusions in patients with:

* degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies),

* spondylolisthesis,

* trauma (i.e. fractures or dislocations),

* tumors,

* deformity (defined as kyphosis, lordosis or scoliosis),

* pseudarthrosis,

* failed previous fusion,

* spinal stenosis.

Indications for use as stated in the FDA summary.

Also cleared against K061002

5 other devices cite the same predicate.

  • K140234Aspiron Acp SystemU&I Corp. · 2014
  • K131200Aspiron Acp SystemU&I Corporation · 2013
  • K121862Rex Anterior Cervical Plate SystemDio Medical Co., Ltd. · 2012
  • K121078Van Gogh Anterior Cervical Plate SystemAccel Spine · 2012
  • K102265LDR Spine Usa C-Plate, TL Anterior Cervical Plate SystemLdr Spine USA · 2010

More from L&K BIOMED Co., Ltd.

58 FDA decisions under this applicant name. See the company

  • K262489BluEX Cervical Expandable Cage SystemL&K BIOMED Co., Ltd. · 2026
  • K260840BluEX Cervical Expandable Cage SystemL&K BIOMED Co., Ltd. · 2026
  • K261112CastleLoc-P Anterior Cervical Plate SystemL&K BIOMED Co., Ltd. · 2026
  • K261130AccelFix Spinal Fixation SystemL&K BIOMED Co., Ltd. · 2026
  • K260448CastleLoc Pectus Bar SystemL&K BIOMED Co., Ltd. · 2026

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/K113509 · printed Nov 6, 2026

Cite this page

510(k) Report. “K113509: Lexus Anterior Cervical Plate System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K113509

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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