510(k) Report

510(k) · Cleared

Cleared

Biomet Anterior Lumbar Plate

K082187510(k) TraditionalCleared Nov 13, 2008101-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

Ebi, L.P. · KWQ Appliance, Fixation, Spinal Intervertebral Body

Cleared on Nov 13, 2008 as substantially equivalent to K022791 (Synthes (Usa), 2002) and 2 other predicates after a 101-day review. Its family tree reaches back 1 generation to 2002. 126 later devices descend from it.

Decided
Nov 13, 2008
Review
101 days
Class
Class II
Product code
KWQ
Recalls
None
Predicates
3

Its longest line of descent runs back 1 generation to K022791 (2002). 3 ancestors in all. 126 later devices descend from it, 2 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2006: 1 other ancestor2004: 1 other ancestor2012: 1 descendant cleared2019: 6 descendants cleared2018: 1 descendant cleared2020: 11 descendants cleared2021: 8 descendants cleared2023: 19 descendants cleared2022: 13 descendants cleared2024: 20 descendants cleared2025: 24 descendants cleared2026: 23 descendants clearedK022791 · Synthes Anterior Tension Band (Atb) System · Synthes (Usa) · 2002200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors 1 generation forward: 2 descendants2 generations forward: 5 descendants3 generations forward: 18 descendants4 generations forward: 35 descendants5 generations forward: 32 descendants6 generations forward: 23 descendants7 generations forward: 8 descendants8 generations forward: 3 descendants K022791 · Synthes Anterior Tension Band (Atb) System · Synthes (Usa) · 20020+5
  1. Root · 1 generation backK022791 Synthes Anterior Tension Band (Atb) SystemSynthes (Usa) · 2002
  2. This deviceK082187 Biomet Anterior Lumbar PlateEbi, L.P. · 2008
  3. Descendant · cites it directly · 113 of its ownK121791 Zou Anterior Lumbar Plate SystemCorelink, LLC · 2012
  4. Descendant · 2 generations on · 110 of its ownK182746 ATEC ALIF and LLIF Spacer SystemAlphatec Spine, Inc. · 2018
  5. Descendant · 3 generations on · 99 of its ownK183705 IdentiTi Porous Ti Interbody SystemAlphatec Spine, Inc. · 2019
  6. Descendant · 3 generations on · 78 of its ownK191311 ATEC Lateral Interbody SystemAlphatec Spine, Inc. · 2019
  7. Descendant · 4 generations on · 69 of its ownK192938 Invictus™ Spinal Fixation SystemAlphatec Spine, Inc. · 2019

Showing 5 of 126 descendants. See all descendants

Descendants cleared per year

2012: 12018: 12019: 62020: 112021: 82022: 132023: 192024: 202025: 242026: 23
2012high 24 (2025) · low 0 (2013)2026

Most influential descendants

Showing 5 of 126 · See all
  • K121791Zou Anterior Lumbar Plate SystemCorelink, LLC · 2012 · 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
  • K192938Invictus™ Spinal Fixation SystemAlphatec Spine, Inc. · 2019 · 4 generations on69descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K022791Synthes Anterior Tension Band (Atb) SystemSynthes (Usa)2002—
0 (this device)K082187Biomet Anterior Lumbar PlateEbi, L.P.2008—
+1K121791Zou Anterior Lumbar Plate SystemCorelink, LLC2012—
+2K182746ATEC ALIF and LLIF Spacer SystemAlphatec Spine, Inc.2018—
+3K183705IdentiTi Porous Ti Interbody SystemAlphatec Spine, Inc.2019—
+3K191311ATEC Lateral Interbody SystemAlphatec Spine, Inc.2019—
+4K192938Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.2019—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200410
200610

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201210
201810
201960
2020110
202180
2022130
2023190
2024200
2025240
2026230
FIG. 1 — Lineage of K082187, 2002–2026Source: 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? (3)

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
*K022791Synthes Anterior Tension Band (Atb) System
Summary page 1
…tics, and principles of operation and do not present any new issues of safety or effectiveness. Example of predicates include Synthes Anterior Tension Band (ATB) System (K02279 1), Zimmer Trinica® Anterior Lumbar Plate System (K06 1353) and EBI's Top Loading MAS Spinal Fixation System (K033312).Based upon t…
Synthes (Usa)2002—
*K061353Trinica Anterior Lumbar Plate System
Summary page 1
…new issues of safety or effectiveness. Example of predicates include Synthes Anterior Tension Band (ATB) System (K02279 1), Zimmer Trinica® Anterior Lumbar Plate System (K06 1353) and EBI's Top Loading MAS Spinal Fixation System (K033312).Based upon the mechanical testing, the Biomet Anterior Lumbar Plate i…
Zimmer Spine, Inc.20061
*K033312Ebi Top Loading Mas Spinal Fixation System
Summary page 1
…include Synthes Anterior Tension Band (ATB) System (K02279 1), Zimmer Trinica® Anterior Lumbar Plate System (K06 1353) and EBI's Top Loading MAS Spinal Fixation System (K033312).Based upon the mechanical testing, the Biomet Anterior Lumbar Plate is substantially equivalent for its intended use to other sp…
Ebi, L.P.2004—

Also cleared against K022791: 14 other devices →

What descends from it? (126)

See all 126

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

NumberDeviceApplicantDecidedDescendants
K121791Zou Anterior Lumbar Plate SystemCorelink, LLC2012113
K190016Lateral Plate SystemCorelink, LLC201915

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?

  • 1 of the 3 ancestors has a recall of any class.
  • Of its descendants, K121791 (Corelink, LLC, 2012) has gone furthest, with 113 descendants of its own.
  • 14 other devices also cite its predicate K022791.

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. 2008, 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 Anterior Lumbar Plate System is an anterior or antereolateral spinal fixation device indicated for use via the lateral or anterolateral surgical approach above the bifurcation of the great vessels or via the anterior surgical approach, below the bifurcation of the great vessels in the fusion of the lumbar or lumbosacral spine at levels LI through SI. The system is indicated for use in the temporary stabilization of the anterior spine during the…

Read the full statement (123 words)

The Anterior Lumbar Plate System is an anterior or antereolateral spinal fixation device indicated for use via the lateral or anterolateral surgical approach above the bifurcation of the great vessels or via the anterior surgical approach, below the bifurcation of the great vessels in the fusion of the lumbar or lumbosacral spine at levels LI through SI. The system is indicated for use in the temporary stabilization of the anterior spine during the development of solid spinal fusions in patients with degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma including fractures, tumors, deformity (defined as kyphosis, lordosis or scoliosis), pseudoarthrosis, spondyloysis, spondylolisthesis, stenosis and/or failed previous fusion.

Indications for use as stated in the FDA summary.

Also cleared against K022791

14 other devices cite the same predicate.

  • K200846Balteum™ Lumbar Plate SystemHuvexel Co., Ltd. · 2020
  • K173885Genesys Spine Binary Lumbar Plate SystemGenesys Spine · 2018
  • K163625NOOSA Anterior Lumbar Plate System;NAMBUCCA Anterior Lumbar Plate System; CAIRNS Anterior Lumbar Plate SystemSignature Orthopaedics Pty, Ltd. · 2017
  • K171538Cure™ Lumbar Plate SystemMeditech Spine, LLC · 2017
  • K124034Mectalif AnteriorMedacta International · 2013
  • K121791Zou Anterior Lumbar Plate SystemCorelink, LLC · 2012

More from Ebi, L.P.

101 FDA decisions under this applicant name. See the company

  • K100438Polaris Spinal System, Polaris/Synergy Structure Anterior Fixation SystemEbi, L.P. · 2010
  • K100220Polaris Spinal SystemEbi, L.P. · 2010
  • K093880Peanut Growth Control Plating SystemEbi, L.P. · 20101 recall
  • K092574Esl Spinal SystemEbi, L.P. · 2010
  • K093057Biomet Vision Footring SystemEbi, L.P. · 2009

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/K082187 · printed Nov 4, 2026

Cite this page

510(k) Report. “K082187: Biomet Anterior Lumbar Plate.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K082187

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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