510(k) Report

510(k) · Cleared

Cleared

LITe Plate System

K142699510(k) TraditionalCleared Dec 31, 2014100-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

Stryker Corporation · KWQ Appliance, Fixation, Spinal Intervertebral Body

Cleared on Dec 31, 2014 as substantially equivalent to K001844 (Howmedica Osteonics Corp., 2000) and 7 other predicates after a 100-day review. Its family tree reaches back 7 generations to 1999. 46 later devices descend from it.

Decided
Dec 31, 2014
Review
100 days
Class
Class II
Product code
KWQ
Recalls
None
Predicates
8

Its longest line of descent runs back 7 generations to K990745 (1999). 42 ancestors in all, the oldest K922543 (1993). 46 later devices descend from it, 8 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2009: 3 other ancestors2008: 4 other ancestors2000: 3 other ancestors2007: 4 other ancestors2006: 4 other ancestors2002: 4 other ancestors2001: 3 other ancestors1998: 1 other ancestor2005: 2 other ancestors2003: 3 other ancestors1997: 3 other ancestors1993: 1 other ancestor2015: 1 descendant cleared2019: 4 descendants cleared2023: 10 descendants cleared2024: 10 descendants cleared2018: 1 descendant cleared2020: 2 descendants cleared2022: 5 descendants cleared2026: 7 descendants cleared2021: 3 descendants cleared2025: 3 descendants clearedK990745 · Modification to Synthes Universal Spinal System · Synthes Spine · 1999K992739 · Click'x · Synthes Spine · 2000 · recalledK040442 · Protex Stabilization System · Globus Medical, Inc. · 2004K052069 · Protex Stabilization System with Additional Componentes · Globus Medical, Inc. · 2005×3: 3 generations cleared close together, K061202 (2006), K062407 (2006), K062836 (2006) 1990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 7 other ancestors2 generations back: 11 other ancestors3 generations back: 10 other ancestors4 generations back: 7 other ancestors 1 generation forward: 8 descendants2 generations forward: 13 descendants3 generations forward: 12 descendants4 generations forward: 9 descendants5 generations forward: 3 descendants6 generations forward: 1 descendant K062836 · Citadel Anterior Lumbar Plate System · Globus Medical, Inc. · 2006K062407 · Gateway Thoracolumbar Plate System · Globus Medical, Inc. · 2006K061202 · Revere Stabilization System · Globus Medical, Inc. · 2006K052069 · Protex Stabilization System with Additional Componentes · Globus Medical, Inc. · 2005K040442 · Protex Stabilization System · Globus Medical, Inc. · 2004K992739 · Click'x · Synthes Spine · 2000 · recalledK990745 · Modification to Synthes Universal Spinal System · Synthes Spine · 1999−50+5
  1. Root · 7 generations backK990745 Modification to Synthes Universal Spinal SystemSynthes Spine · 1999
  2. 6 generations backK992739 Click'xSynthes Spine · 2000 · Recalled
  3. 5 generations backK040442 Protex Stabilization SystemGlobus Medical, Inc. · 2004
  4. 4 generations backK052069 Protex Stabilization System with Additional ComponentesGlobus Medical, Inc. · 2005
  5. 3 generations backK061202 Revere Stabilization SystemGlobus Medical, Inc. · 2006
  6. 2 generations backK062407 Gateway Thoracolumbar Plate SystemGlobus Medical, Inc. · 2006
  7. 1 generation backK062836 Citadel Anterior Lumbar Plate SystemGlobus Medical, Inc. · 2006
  8. This deviceK142699 LITe Plate SystemStryker Corporation · 2014
  9. Descendant · cites it directly · 24 of its ownK150449 LITe Plate SystemStryker Corp. · 2015
  10. Descendant · 2 generations on · 15 of its ownK190016 Lateral Plate SystemCorelink, LLC · 2019
  11. Descendant · cites it directly · 13 of its ownK192481 AccelFix Lumbar Plate SystemL&K BIOMED Co., Ltd. · 2020
  12. Descendant · 2 generations on · 10 of its ownK210035 ZESPIN SI Joint Fusion System, MegaCerfix Posterior Cervical…Aegis Spine · 2021
  13. Descendant · 3 generations on · 9 of its ownK203065 Lumbar Spine Truss System Plating Solution (LSTS-PS)4Web, Inc. · 2021

Showing 5 of 46 descendants. See all descendants

Descendants cleared per year

2015: 12018: 12019: 42020: 22021: 32022: 52023: 102024: 102025: 32026: 7
2015high 10 (2023) · low 0 (2016)2026

Most influential descendants

Showing 5 of 46 · See all
  • K150449LITe Plate SystemStryker Corp. · 2015 · cites it directly24descendants
  • K190016Lateral Plate SystemCorelink, LLC · 2019 · 2 generations on15descendants
  • K192481AccelFix Lumbar Plate SystemL&K BIOMED Co., Ltd. · 2020 · cites it directly13descendants
  • K210035ZESPIN SI Joint Fusion System, MegaCerfix Posterior Cervical Fixation System, MegaCerfix…Aegis Spine · 2021 · 2 generations on10descendants
  • K203065Lumbar Spine Truss System Plating Solution (LSTS-PS)4Web, Inc. · 2021 · 3 generations on9descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−7K990745Modification to Synthes Universal Spinal SystemSynthes Spine1999—
−6K992739Click'xSynthes Spine20001
−5K040442Protex Stabilization SystemGlobus Medical, Inc.2004—
−4K052069Protex Stabilization System with Additional ComponentesGlobus Medical, Inc.2005—
−3K061202Revere Stabilization SystemGlobus Medical, Inc.2006—
−2K062407Gateway Thoracolumbar Plate SystemGlobus Medical, Inc.2006—
−1K062836Citadel Anterior Lumbar Plate SystemGlobus Medical, Inc.2006—
0 (this device)K142699LITe Plate SystemStryker Corporation2014—
+1K150449LITe Plate SystemStryker Corp.2015—
+2K190016Lateral Plate SystemCorelink, LLC2019—
+1K192481AccelFix Lumbar Plate SystemL&K BIOMED Co., Ltd.2020—
+2K210035ZESPIN SI Joint Fusion System, MegaCerfix Posterior Cervical Fixation System…Aegis Spine2021—
+3K203065Lumbar Spine Truss System Plating Solution (LSTS-PS)4Web, Inc.2021—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199310
199730
199810
200030
200130
200240
200330
200520
200640
200740
200840
200930

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201510
201810
201940
202020
202130
202250
2023100
2024100
202530
202670
FIG. 1 — Lineage of K142699, 1999–2026Source: 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? (8)

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
*K001844Modification to Centaur Spinal System
Summary page 4
…l body fixation orthosis and Number 21 CFR §888.3060 Product Code KWQ Predicate Devices Primary Predicate: Stryker Spine, CENTAUR™ Spinal System, K001844 Additional Predicates: Universal, Sacral, 2 Screw, and 4 Screw Plates…
Howmedica Osteonics Corp.2000—
*K994347Centaur Spinal System
Summary page 4
…Additional Predicates: Universal, Sacral, 2 Screw, and 4 Screw Plates • Stryker Spine, CENTAUR™ Spinal System, K994347 • Medtronic, PYRAMID® +4 Anterior Lumbar Plate System, K080429 • NuVasive, Lateral Pl…
Howmedica Osteonics Corp.2000—
*K080429Modificaton to: Pyramid +4 Anterior Lumbar Plate System
Summary page 4
…w, and 4 Screw Plates • Stryker Spine, CENTAUR™ Spinal System, K994347 • Medtronic, PYRAMID® +4 Anterior Lumbar Plate System, K080429 • NuVasive, Lateral Plate System, K091071 • Spinal USA, Anterior Lumbar Plate System,…
Medtronic Sofamor Danek USA, Inc.2008—
*K091071Nuvasive Lateral Plate System
Summary page 4
…TAUR™ Spinal System, K994347 • Medtronic, PYRAMID® +4 Anterior Lumbar Plate System, K080429 • NuVasive, Lateral Plate System, K091071 • Spinal USA, Anterior Lumbar Plate System, K091044 • Globus Medical, CITADEL™ Anteri…
Nuvasive, Inc.2009—
*K091044Spinal Usa Anterior Lumbar Plate System
Summary page 4
…4 Anterior Lumbar Plate System, K080429 • NuVasive, Lateral Plate System, K091071 • Spinal USA, Anterior Lumbar Plate System, K091044 • Globus Medical, CITADEL™ Anterior Lumbar Plate System, K062836 • Stryker Spine, THO…
Spinal USA2009—
*K062836Citadel Anterior Lumbar Plate System
Summary page 4
…System, K091071 • Spinal USA, Anterior Lumbar Plate System, K091044 • Globus Medical, CITADEL™ Anterior Lumbar Plate System, K062836 • Stryker Spine, THOR Anterior Lumbar Plate, K080773 Buttress Plate…
Globus Medical, Inc.2006—
*K080773Thor Anterior Plating System
Summary page 4
…System, K091044 • Globus Medical, CITADEL™ Anterior Lumbar Plate System, K062836 • Stryker Spine, THOR Anterior Lumbar Plate, K080773 Buttress Plate • Spinal USA, RCS Anterior Buttress Plate, K092659…
Stryker Spine2008—
*K092659Spinal Usa RCS Anterior Lumbar Butress Plate System, Model 22-1001-25
Summary page 4
…• Stryker Spine, THOR Anterior Lumbar Plate, K080773 Buttress Plate • Spinal USA, RCS Anterior Buttress Plate, K092659 • Spinal USA, Anterior Lumbar Plate System, K091044 • Stryker Spine, THOR Anterior Lu…
Spinal USA2009—

Also cleared against K001844: 3 other devices →

What descends from it? (46)

See all 46

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

NumberDeviceApplicantDecidedDescendants
K150449LITe Plate SystemStryker Corp.201524
K192481AccelFix Lumbar Plate SystemL&K BIOMED Co., Ltd.202013
K173885Genesys Spine Binary Lumbar Plate SystemGenesys Spine20184
K223719Paeon Anterior Cervical Plate System, Elatus Lumbar Plate SystemAegis Spine, Inc.20233
K190584CAYMAN LP Plate SystemK2m, Inc.20192
K232256Alcantara Thoracolumbar Plate SystemCamber Spine Technologies, LLC20240
K233360Curiteva Thoracolumbar Plate SystemCuriteva, Inc.20240
K232318VICTORY™ Lumbar Plate SystemGlobus Medical, Inc.20230

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 15 years and passes through 3 companies; a new generation was cleared every 11 months on median.
  • 3 of the 42 ancestors have a recall of any class.
  • Of its descendants, K150449 (Stryker Corp., 2015) has gone furthest, with 24 descendants of its own.
  • 3 other devices also cite its predicate K001844.

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. 2014, 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 LITe® Plate System Universal, Sacral, 2 Screw and 4 Screw Plates are indicated for use via a lateral or anterolateral surgical approach above the bifurcation of the great vessels in the treatment of the thoracic and thoracolumbar (T1-L5) spine or via an anterior approach below the bifurcation of the great vessels in the treatment of lumbar and lumbosacral (L1-S1) spine. The system is intended to provide additional support during fusion in skeletally…

Read the full statement (193 words)

The LITe® Plate System Universal, Sacral, 2 Screw and 4 Screw Plates are indicated for use via a lateral or anterolateral surgical approach above the bifurcation of the great vessels in the treatment of the thoracic and thoracolumbar (T1-L5) spine or via an anterior approach below the bifurcation of the great vessels in the treatment of lumbar and lumbosacral (L1-S1) spine. The system is intended to provide additional support during fusion in skeletally mature patients in the treatment of the following acute and chronic instabilities or deformities: Degenerative Disc Disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies); Pseudoarthrosis; Spondylolysis; Spondylolisthesis; Spinal stenosis; Tumors; Trauma (i.e. Fractures or Dislocation); Deformities (i.e. Scoliosis, Kyphosis or Lordosis); Failed Previous Fusion

The LITe® Plate System Buttress Plate is intended to stabilize the allograft or autograft at one level (T1-S1) as an aid to spinal fusion and to provide temporary stabilization and augment development of a solid spinal fusion. It may be used alone or with other anterior, anterolateral, or posterior spinal systems made of compatible materials. This device is not intended for load bearing applications.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K001844

3 other devices cite the same predicate.

  • K150449LITe Plate SystemStryker Corp. · 2015
  • K080773Thor Anterior Plating SystemStryker Spine · 2008
  • K073437Thor Anterior Plating SystemStryker Spine · 200831 recalls

More from Stryker Corporation

87 FDA decisions under this applicant name. See the company

  • K232157Connected OR Hub with Device and Voice Control, SDC4K Information Management System with Device and Voice…Stryker Corporation · 2023
  • K223770Sonopet 1Q 3 7cm 1Q LargeStryker Corporation · 2023
  • K212194Stryker Q Guidance System with Cranial Guidance Software, CranialMask Tracker and Microscope Tracker…Stryker Corporation · 20232 recalls
  • K221728Aviator® Anterior Cervical Plating (ACP) System, LITe® Plate System, DynaTran™ Anterior Cervical Plating…Stryker Corporation · 2022
  • K221074OptaBlate RF Generator, OptaBlate Probes, OptaBlate Microinfuser Infusion DeviceStryker Corporation · 2022

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/K142699 · printed Nov 6, 2026

Cite this page

510(k) Report. “K142699: LITe 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/K142699

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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