510(k) Report

510(k) · Cleared

Cleared

Trinica Anterior Lumbar Plate System

K140611510(k) TraditionalCleared May 21, 201472-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

Zimmer Spine, Inc. · KWQ Appliance, Fixation, Spinal Intervertebral Body

Cleared on May 21, 2014 as substantially equivalent to K061353 (Zimmer Spine, Inc., 2006) after a 72-day review. Its family tree reaches back 1 generation to 2006. 17 later devices descend from it.

Decided
May 21, 2014
Review
72 days
Class
Class II
Product code
KWQ
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K061353 (2006). 17 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2015: 1 descendant cleared2020: 1 descendant cleared2023: 7 descendants cleared2024: 2 descendants cleared2021: 2 descendants cleared2026: 2 descendants cleared2022: 2 descendants clearedK061353 · Trinica Anterior Lumbar Plate System · Zimmer Spine, Inc. · 2006 · recalled20052010201520202025
Descendants, by generation 1 generation forward: 1 descendant2 generations forward: 4 descendants3 generations forward: 5 descendants4 generations forward: 5 descendants5 generations forward: 2 descendants K061353 · Trinica Anterior Lumbar Plate System · Zimmer Spine, Inc. · 2006 · recalled0+5
  1. Root · 1 generation backK061353 Trinica Anterior Lumbar Plate SystemZimmer Spine, Inc. · 2006 · Recalled
  2. This deviceK140611 Trinica Anterior Lumbar Plate SystemZimmer Spine, Inc. · 2014
  3. Descendant · cites it directly · 16 of its ownK143626 inVizia Anterior Certical Plate System, SC-AcuFix Ant-Cer Dynamic…Zimmer Spine, Inc. · 2015
  4. Descendant · 2 generations on · 13 of its ownK192481 AccelFix Lumbar Plate SystemL&K BIOMED Co., Ltd. · 2020
  5. Descendant · 3 generations on · 10 of its ownK210035 ZESPIN SI Joint Fusion System, MegaCerfix Posterior Cervical…Aegis Spine · 2021
  6. Descendant · 4 generations on · 6 of its ownK221050 ZESPIN SI Joint Fusion System, Paeon Posterior Cervical Fixation…Aegis Spine, Inc. · 2022
  7. Descendant · 2 generations on · 3 of its ownK223719 Paeon Anterior Cervical Plate System, Elatus Lumbar Plate SystemAegis Spine, Inc. · 2023

Showing 5 of 17 descendants. See all descendants

Descendants cleared per year

2015: 12020: 12021: 22022: 22023: 72024: 22026: 2
2015high 7 (2023) · low 0 (2016)2026

Most influential descendants

Showing 5 of 17 · See all
  • K143626inVizia Anterior Certical Plate System, SC-AcuFix Ant-Cer Dynamic Cervical Plating…Zimmer Spine, Inc. · 2015 · cites it directly16descendants
  • 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
  • K221050ZESPIN SI Joint Fusion System, Paeon Posterior Cervical Fixation System, Paeon Anterior…Aegis Spine, Inc. · 2022 · 4 generations on6descendants
  • K223719Paeon Anterior Cervical Plate System, Elatus Lumbar Plate SystemAegis Spine, Inc. · 2023 · 2 generations on3descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K061353Trinica Anterior Lumbar Plate SystemZimmer Spine, Inc.20061
0 (this device)K140611Trinica Anterior Lumbar Plate SystemZimmer Spine, Inc.2014—
+1K143626inVizia Anterior Certical Plate System, SC-AcuFix Ant-Cer Dynamic Cervical…Zimmer Spine, Inc.2015—
+2K192481AccelFix Lumbar Plate SystemL&K BIOMED Co., Ltd.2020—
+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—
+2K223719Paeon Anterior Cervical Plate System, Elatus Lumbar Plate SystemAegis Spine, Inc.2023—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201510
202010
202120
202220
202370
202420
202620
FIG. 1 — Lineage of K140611, 2006–2026Source: 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? (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
*K061353Trinica Anterior Lumbar Plate System
Summary page 1
…11 Regulation Number and 21 CFR § 888.3060 / KWQ Product Code(s): Predicate Devices: Trinica® Anterior Lumbar Plate System (K061353) General Device Description: The Trinica® Anterior Lumbar Plate (ALP) System is a temporary supplemental fixation device consist…
Zimmer Spine, Inc.20061

Also cleared against K061353: 3 other devices →

What descends from it? (17)

See all 17

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K143626inVizia Anterior Certical Plate System, SC-AcuFix Ant-Cer Dynamic Cervical Plating…Zimmer Spine, Inc.201516

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?

  • Its one ancestor has a recall.
  • Of its descendants, K143626 (Zimmer Spine, Inc., 2015) has gone furthest, with 16 descendants of its own.
  • 3 other devices also cite its predicate K061353.

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 Trinica® Anterior Lumbar Plate System is 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. This system is indicated in the treatment of lumbar or lumbosacral (L1-S1) spine instability as a result of fracture (including dislocation and subluxation), tumor, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), pseudoarthrosis, spondylolisthesis, scoliosis, lordotic deformities of the spine, spinal stenosis, or a failed previous fusion.

Indications for use as stated in the FDA summary.

Also cleared against K061353

3 other devices cite the same predicate.

  • K121791Zou Anterior Lumbar Plate SystemCorelink, LLC · 2012
  • K082187Biomet Anterior Lumbar PlateEbi, L.P. · 2008
  • K070922Modification to Spinal Usa VBR SystemSpinal USA · 2007

More from Zimmer Spine, Inc.

52 FDA decisions under this applicant name. See the company

  • K153631Zimmer Virage OCT Spinal Fixation SystemZimmer Spine, Inc. · 2016
  • K150896Vitality Spinal Fixation SystemZimmer Spine, Inc. · 20153 recalls
  • K151031Virage OCT Spinal Fixation SystemZimmer Spine, Inc. · 2015
  • K142752Minit Posterior Cervical-Thoracic Fixation System, Nex-Link Spinal Fixation System, Nex-Link OCT Cervical…Zimmer Spine, Inc. · 2015
  • K143626inVizia Anterior Certical Plate System, SC-AcuFix Ant-Cer Dynamic Cervical Plating System, SC-AcuFix…Zimmer Spine, Inc. · 2015

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/K140611 · printed Nov 6, 2026

Cite this page

510(k) Report. “K140611: Trinica Anterior Lumbar 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/K140611

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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