510(k) Report

510(k) · Cleared

Recalled · Class II · 2013

Trinica Anterior Lumbar Plate System

K061353510(k) TraditionalCleared Aug 30, 2006107-day reviewClass II21 CFR 888.3060Recalls 1

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 Aug 30, 2006 after a 107-day review. The FDA summary names its predicate without a number. 167 later devices descend from it. It has been recalled once.

Decided
Aug 30, 2006
Review
107 days
Class
Class II
Product code
KWQ
Recalls
1
Predicates
0

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

Descendants, by year cleared 2012: 2 descendants cleared2007: 1 descendant cleared2008: 1 descendant cleared2014: 2 descendants cleared2021: 11 descendants cleared2016: 1 descendant cleared2009: 1 descendant cleared2019: 8 descendants cleared2018: 3 descendants cleared2015: 2 descendants cleared2010: 1 descendant cleared2020: 12 descendants cleared2023: 27 descendants cleared2024: 27 descendants cleared2022: 17 descendants cleared2025: 24 descendants cleared2026: 27 descendants cleared20052010201520202025
  1. This deviceK061353 Trinica Anterior Lumbar Plate SystemZimmer Spine, Inc. · 2006
  2. Descendant · cites it directly · 161 of its ownK070922 Modification to Spinal Usa VBR SystemSpinal USA · 2007
  3. Descendant · 2 generations on · 159 of its ownK091044 Spinal Usa Anterior Lumbar Plate SystemSpinal USA · 2009
  4. Descendant · cites it directly · 126 of its ownK082187 Biomet Anterior Lumbar PlateEbi, L.P. · 2008
  5. Descendant · cites it directly · 113 of its ownK121791 Zou Anterior Lumbar Plate SystemCorelink, LLC · 2012
  6. Descendant · 3 generations on · 113 of its ownK101255 Alphatec Spine Anterior Lumbar Plating SystemAlphatec Spine, Inc. · 2010

Showing 5 of 167 descendants. See all descendants

Descendants cleared per year

2007: 12008: 12009: 12010: 12012: 22014: 22015: 22016: 12018: 32019: 82020: 122021: 112022: 172023: 272024: 272025: 242026: 27
2007high 27 (2023) · low 0 (2011)2026

Most influential descendants

Showing 5 of 167 · See all
  • K070922Modification to Spinal Usa VBR SystemSpinal USA · 2007 · cites it directly161descendants
  • K091044Spinal Usa Anterior Lumbar Plate SystemSpinal USA · 2009 · 2 generations on159descendants
  • K082187Biomet Anterior Lumbar PlateEbi, L.P. · 2008 · cites it directly126descendants
  • K121791Zou Anterior Lumbar Plate SystemCorelink, LLC · 2012 · cites it directly113descendants
  • K101255Alphatec Spine Anterior Lumbar Plating SystemAlphatec Spine, Inc. · 2010 · 3 generations on113descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K061353Trinica Anterior Lumbar Plate SystemZimmer Spine, Inc.2006—
+1K070922Modification to Spinal Usa VBR SystemSpinal USA2007—
+2K091044Spinal Usa Anterior Lumbar Plate SystemSpinal USA2009—
+1K082187Biomet Anterior Lumbar PlateEbi, L.P.2008—
+1K121791Zou Anterior Lumbar Plate SystemCorelink, LLC2012—
+3K101255Alphatec Spine Anterior Lumbar Plating SystemAlphatec Spine, Inc.2010—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200710
200810
200910
201010
201220
201420
201520
201610
201830
201980
2020120
2021110
2022170
2023270
2024270
2025240
2026270
FIG. 1 — Lineage of K061353, 2006–2026Source: 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? (2)

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
*—Synthes Anterior Tension Band (ATB) System
Named without a submission number
—
*—DePuy Spine AEGIS Anterior Lumbar Plate System
Named without a submission number
—

What descends from it? (167)

See all 167

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

NumberDeviceApplicantDecidedDescendants
K070922Modification to Spinal Usa VBR SystemSpinal USA2007161
K082187Biomet Anterior Lumbar PlateEbi, L.P.2008126
K121791Zou Anterior Lumbar Plate SystemCorelink, LLC2012113
K140611Trinica Anterior Lumbar Plate SystemZimmer Spine, Inc.201417

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Oct 9, 2013Class IIZ-0357-2014Device DesignZimmer Spine, Inc. is initiating a correction regarding the Trinica ALP Instrument Tray, part 07.01058.001 (all lots). The Ratchet Handles, part 07.00438.001 may not be effectively sterilized if left in their designated location(s) in the…

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K070922 (Spinal USA, 2007) has gone furthest, with 161 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.

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.

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/K061353 · printed Nov 4, 2026

Cite this page

510(k) Report. “K061353: Trinica 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/K061353

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