510(k) Report

510(k) · Cleared

Cleared

Spinal Usa Anterior Lumbar Plate System

K091044510(k) SpecialCleared Jul 9, 200987-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 Jul 9, 2009 as substantially equivalent to K070922 (Spinal USA, 2007) after an 87-day review. Its family tree reaches back 5 generations to 1993. 159 later devices descend from it.

Decided
Jul 9, 2009
Review
87 days
Class
Class II
Product code
KWQ
Recalls
None
Predicates
1

Its longest line of descent runs back 5 generations to K922543 (1993). 11 ancestors in all. 159 later devices descend from it, 7 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2006: 2 other ancestors2002: 1 other ancestor2001: 1 other ancestor2000: 1 other ancestor1997: 1 other ancestor2012: 2 descendants cleared2021: 11 descendants cleared2018: 3 descendants cleared2019: 8 descendants cleared2010: 1 descendant cleared2014: 1 descendant cleared2015: 1 descendant cleared2023: 26 descendants cleared2024: 26 descendants cleared2020: 12 descendants cleared2026: 27 descendants cleared2022: 17 descendants cleared2025: 24 descendants clearedK922543 · Z-Plate Anterior Fixation System · Sofamor Danek Mfg., Inc. · 1993K013665 · Pyramid Anterior Plate Fixation System · Medtronic Sofamor Danek, Inc. · 2002K043548 · Blackstone Unity Anterior Lumbar Plate Fixation System · Blackstone Medical, Inc. · 2005K061229 · Unity LX Anterolateral Lumbar Plate Fixation System · Blackstone Medical, Inc. · 2006K070922 · Modification to Spinal Usa VBR System · Spinal USA · 20071990200020102020
Other ancestors, by generationDescendants, by generation 2 generations back: 3 other ancestors3 generations back: 3 other ancestors 1 generation forward: 7 descendants2 generations forward: 16 descendants3 generations forward: 26 descendants4 generations forward: 43 descendants5 generations forward: 34 descendants6 generations forward: 22 descendants7 generations forward: 8 descendants8 generations forward: 3 descendants K070922 · Modification to Spinal Usa VBR System · Spinal USA · 2007K061229 · Unity LX Anterolateral Lumbar Plate Fixation System · Blackstone Medical, Inc. · 2006K043548 · Blackstone Unity Anterior Lumbar Plate Fixation System · Blackstone Medical, Inc. · 2005K013665 · Pyramid Anterior Plate Fixation System · Medtronic Sofamor Danek, Inc. · 2002K922543 · Z-Plate Anterior Fixation System · Sofamor Danek Mfg., Inc. · 1993−50+5
  1. Root · 5 generations backK922543 Z-Plate Anterior Fixation SystemSofamor Danek Mfg., Inc. · 1993
  2. 4 generations backK013665 Pyramid Anterior Plate Fixation SystemMedtronic Sofamor Danek, Inc. · 2002
  3. 3 generations backK043548 Blackstone Unity Anterior Lumbar Plate Fixation SystemBlackstone Medical, Inc. · 2005
  4. 2 generations backK061229 Unity LX Anterolateral Lumbar Plate Fixation SystemBlackstone Medical, Inc. · 2006
  5. 1 generation backK070922 Modification to Spinal Usa VBR SystemSpinal USA · 2007
  6. This deviceK091044 Spinal Usa Anterior Lumbar Plate SystemSpinal USA · 2009
  7. Descendant · cites it directly · 113 of its ownK121791 Zou Anterior Lumbar Plate SystemCorelink, LLC · 2012
  8. Descendant · cites it directly · 113 of its ownK101255 Alphatec Spine Anterior Lumbar Plating SystemAlphatec Spine, Inc. · 2010
  9. Descendant · 2 generations on · 110 of its ownK182746 ATEC ALIF and LLIF Spacer SystemAlphatec Spine, Inc. · 2018
  10. Descendant · 3 generations on · 99 of its ownK183705 IdentiTi Porous Ti Interbody SystemAlphatec Spine, Inc. · 2019
  11. Descendant · 3 generations on · 78 of its ownK191311 ATEC Lateral Interbody SystemAlphatec Spine, Inc. · 2019

Showing 5 of 159 descendants. See all descendants

Descendants cleared per year

2010: 12012: 22014: 12015: 12018: 32019: 82020: 122021: 112022: 172023: 262024: 262025: 242026: 27
2010high 27 (2026) · low 0 (2011)2026

Most influential descendants

Showing 5 of 159 · See all
  • K121791Zou Anterior Lumbar Plate SystemCorelink, LLC · 2012 · cites it directly113descendants
  • K101255Alphatec Spine Anterior Lumbar Plating SystemAlphatec Spine, Inc. · 2010 · cites it directly113descendants
  • K182746ATEC ALIF and LLIF Spacer SystemAlphatec Spine, Inc. · 2018 · 2 generations on110descendants
  • K183705IdentiTi Porous Ti Interbody SystemAlphatec Spine, Inc. · 2019 · 3 generations on99descendants
  • K191311ATEC Lateral Interbody SystemAlphatec Spine, Inc. · 2019 · 3 generations on78descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−5K922543Z-Plate Anterior Fixation SystemSofamor Danek Mfg., Inc.1993—
−4K013665Pyramid Anterior Plate Fixation SystemMedtronic Sofamor Danek, Inc.2002—
−3K043548Blackstone Unity Anterior Lumbar Plate Fixation SystemBlackstone Medical, Inc.2005—
−2K061229Unity LX Anterolateral Lumbar Plate Fixation SystemBlackstone Medical, Inc.2006—
−1K070922Modification to Spinal Usa VBR SystemSpinal USA2007—
0 (this device)K091044Spinal Usa Anterior Lumbar Plate SystemSpinal USA2009—
+1K121791Zou Anterior Lumbar Plate SystemCorelink, LLC2012—
+1K101255Alphatec Spine Anterior Lumbar Plating SystemAlphatec Spine, Inc.2010—
+2K182746ATEC ALIF and LLIF Spacer SystemAlphatec Spine, Inc.2018—
+3K183705IdentiTi Porous Ti Interbody SystemAlphatec Spine, Inc.2019—
+3K191311ATEC Lateral Interbody SystemAlphatec Spine, Inc.2019—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199710
200010
200110
200210
200620

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201010
201220
201410
201510
201830
201980
2020120
2021110
2022170
2023260
2024260
2025240
2026270
FIG. 1 — Lineage of K091044, 1993–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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? (1)

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
*K070922Modification to Spinal Usa VBR System
Summary page 1
…88.3060 Classification: Class II Product Code: KWQ Predicate Devices: Spinal USA Anterior Lumbar Plate System (K070922) INTENDED USE: The Spinal USA Anterior Lumbar Plate System is intended for use as an anteriorly placed supplemental fixation…
Spinal USA2007—

Also cleared against K070922: 2 other devices →

What descends from it? (159)

See all 159

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

NumberDeviceApplicantDecidedDescendants
K121791Zou Anterior Lumbar Plate SystemCorelink, LLC2012113
K101255Alphatec Spine Anterior Lumbar Plating SystemAlphatec Spine, Inc.2010113
K142699LITe Plate SystemStryker Corporation201446
K190016Lateral Plate SystemCorelink, LLC201915
K173885Genesys Spine Binary Lumbar Plate SystemGenesys Spine20184
K212937Dakota ALIF Plate SystemPrecision Spine, Inc.20210
K121323Medicrea International Anterior Lumbar PlateMedicrea International20120

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 16 years and passes through 4 companies; a new generation was cleared every 1.8 years on median.
  • 1 of the 11 ancestors has a recall of any class.
  • Of its descendants, K121791 (Corelink, LLC, 2012) has gone furthest, with 113 descendants of its own.
  • 2 other devices also cite its predicate K070922.

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 Anterior Lumbar Plate System is intended for use as an anteriorly placed supplemental fixation device via the lateral or anterolateral surgical approach above the bifurcation of the great vessel or via the anterior surgical approach, below the bifurcation of the great vessels. The device is intended as a temporary fixation device until fusion is achieved. The Spinal USA Anterior Lumbar Plate System is intended for anterior lumbar (1I-S 1)…

Read the full statement (140 words)

The Spinal USA Anterior Lumbar Plate System is intended for use as an anteriorly placed supplemental fixation device via the lateral or anterolateral surgical approach above the bifurcation of the great vessel or via the anterior surgical approach, below the bifurcation of the great vessels. The device is intended as a temporary fixation device until fusion is achieved. The Spinal USA Anterior Lumbar Plate System is intended for anterior lumbar (1I-S 1) fixation for the following indications: degenerative disc disease (DDD), defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma (i.e., fracture or dislocation), deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion. The Spinal USA Anterior Lumbar Plate System is intended to be used with autograft and/'or allograft as an adjunct to fusion.

Indications for use as stated in the FDA summary.

Also cleared against K070922

2 other devices cite the same predicate.

  • K212937Dakota ALIF Plate SystemPrecision Spine, Inc. · 2021
  • K162211AccuFit Lateral Plate SystemPrecision Spine, Inc. · 2016

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/K091044 · printed Nov 4, 2026

Cite this page

510(k) Report. “K091044: Spinal Usa Anterior Lumbar Plate System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K091044

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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