510(k) Report

510(k) · Cleared

Cleared

Spinal Usa RCS Anterior Lumbar Butress Plate System, Model 22-1001-25

K092659510(k) TraditionalCleared Nov 17, 200981-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

Spinal USA · KWQ Appliance, Fixation, Spinal Intervertebral Body

Cleared on Nov 17, 2009 after an 81-day review. The FDA summary names no predicate by number. 50 later devices descend from it.

Decided
Nov 17, 2009
Review
81 days
Class
Class II
Product code
KWQ
Recalls
None
Predicates
0

50 later devices descend from it, 4 citing it directly.

Descendants, by year cleared 2022: 6 descendants cleared2018: 2 descendants cleared2014: 1 descendant cleared2017: 1 descendant cleared2015: 1 descendant cleared2019: 4 descendants cleared2023: 10 descendants cleared2024: 10 descendants cleared2020: 2 descendants cleared2026: 7 descendants cleared2021: 3 descendants cleared2025: 3 descendants cleared20052010201520202025
  1. This deviceK092659 Spinal Usa RCS Anterior Lumbar Butress Plate System, Model 22-1001-25Spinal USA · 2009
  2. Descendant · cites it directly · 46 of its ownK142699 LITe Plate SystemStryker Corporation · 2014
  3. Descendant · 2 generations on · 24 of its ownK150449 LITe Plate SystemStryker Corp. · 2015
  4. Descendant · 3 generations on · 15 of its ownK190016 Lateral Plate SystemCorelink, LLC · 2019
  5. Descendant · 2 generations on · 13 of its ownK192481 AccelFix Lumbar Plate SystemL&K BIOMED Co., Ltd. · 2020
  6. Descendant · 3 generations on · 10 of its ownK210035 ZESPIN SI Joint Fusion System, MegaCerfix Posterior Cervical…Aegis Spine · 2021

Showing 5 of 50 descendants. See all descendants

Descendants cleared per year

2014: 12015: 12017: 12018: 22019: 42020: 22021: 32022: 62023: 102024: 102025: 32026: 7
2014high 10 (2023) · low 0 (2016)2026

Most influential descendants

Showing 5 of 50 · See all
  • K142699LITe Plate SystemStryker Corporation · 2014 · cites it directly46descendants
  • K150449LITe Plate SystemStryker Corp. · 2015 · 2 generations on24descendants
  • K190016Lateral Plate SystemCorelink, LLC · 2019 · 3 generations on15descendants
  • K192481AccelFix Lumbar Plate SystemL&K BIOMED Co., Ltd. · 2020 · 2 generations on13descendants
  • K210035ZESPIN SI Joint Fusion System, MegaCerfix Posterior Cervical Fixation System, MegaCerfix…Aegis Spine · 2021 · 3 generations on10descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K092659Spinal Usa RCS Anterior Lumbar Butress Plate System, Model 22-1001-25Spinal USA2009—
+1K142699LITe Plate SystemStryker Corporation2014—
+2K150449LITe Plate SystemStryker Corp.2015—
+3K190016Lateral Plate SystemCorelink, LLC2019—
+2K192481AccelFix Lumbar Plate SystemL&K BIOMED Co., Ltd.2020—
+3K210035ZESPIN SI Joint Fusion System, MegaCerfix Posterior Cervical Fixation System…Aegis Spine2021—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201410
201510
201710
201820
201940
202020
202130
202260
2023100
2024100
202530
202670
FIG. 1 — Lineage of K092659, 2009–2026Source: 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
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What was it cleared against?

The FDA summary names no predicate by number.

What descends from it? (50)

See all 50

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

NumberDeviceApplicantDecidedDescendants
K142699LITe Plate SystemStryker Corporation201446
K181063Kestrel™ Buttress Plate SystemInnovasis, Inc.20184
K222628Life Spine ALIF Buttress Plate SystemLife Spine, Inc.20220
K173091Boundary Anterior Lumbar Buttress PlateNvision Biomedical Technologies, LLC20170

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, K142699 (Stryker Corporation, 2014) has gone furthest, with 46 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. 2009, 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 Spinal USA RCS Anterior Buttress Plate System is intended to stabilize the allograft or autograft at on level (TI-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. The device is not intended for load bearing applications.

Indications for use as stated in the FDA summary.

More from Spinal USA

23 FDA decisions under this applicant name. See the company

  • K132029Vault-C Intervertebral Body Fusion DeviceSpinal USA · 2013
  • K130863Facet Screw SystemSpinal USA · 2013
  • K131343Reform Pedicle Screw SystemSpinal USA · 2013
  • K130279Reform Pedicle Screw SystemSpinal USA · 2013
  • K130445Vault Alif SystemSpinal USA · 2013

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/K092659 · printed Nov 4, 2026

Cite this page

510(k) Report. “K092659: Spinal Usa RCS Anterior Lumbar Butress Plate System, Model 22-1001-25.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K092659

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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