510(k) Report

510(k) · Cleared

Cleared

Trifore (tm) Cervical Plating System

K171112510(k) TraditionalCleared Jun 8, 201755-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

Neurostructures, Inc. · KWQ Appliance, Fixation, Spinal Intervertebral Body

Cleared on Jun 8, 2017 as substantially equivalent to K142060 (Neurostructures, Inc., 2014) and 3 other predicates after a 55-day review. Its family tree reaches back 8 generations to 1992. 1 later device descends from it.

Decided
Jun 8, 2017
Review
55 days
Class
Class II
Product code
KWQ
Recalls
None
Predicates
4

Its longest line of descent runs back 8 generations to K922087 (1992). 29 ancestors in all. 1 later device descends from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2013: 1 other ancestor2012: 1 other ancestor2003: 2 other ancestors2001: 1 other ancestor1998: 4 other ancestors2008: 1 other ancestor2000: 2 other ancestors1997: 1 other ancestor2007: 1 other ancestor2006: 1 other ancestor1999: 3 other ancestors1995: 1 other ancestor1993: 1 other ancestor2004: 1 other ancestor2020: 1 descendant clearedK922087 · Anterior Cervical Plate System · Sofamor Danek Mfg., Inc. · 1992K990005 · Spinal Concepts, Inc. (Sci) Anterior Cervical Plate System · Spinal Concepts, Inc. · 1999 · recalledK000486 · Abc Cervical Plating System · Aesculap, Inc. · 2000K012184 · Blackstone Iii Anterior Cervical Plating System · Blackstone Medical, Inc. · 2002K030595 · Blackstone Fusion Anterior Cervical Plating System · Blackstone Medical, Inc. · 2003K050892 · Hallmarktm Anterior Cervical Plate System · Blackstone Medical, Inc. · 2005 · recalledK100614 · Hallmark Anterior Cervcial Plate System, Hallmark Five-Level Cervical Plates · Blackstone Medical, Inc. · 2010K142060 · Transom Anterior Cervical Plate · Neurostructures, Inc. · 20141990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 3 other ancestors2 generations back: 2 other ancestors3 generations back: 4 other ancestors4 generations back: 8 other ancestors5 generations back: 2 other ancestors6 generations back: 2 other ancestors 1 generation forward: 1 descendant K142060 · Transom Anterior Cervical Plate · Neurostructures, Inc. · 2014K100614 · Hallmark Anterior Cervcial Plate System, Hallmark Five-Level Cervical Plates · Blackstone Medical, Inc. · 2010K050892 · Hallmarktm Anterior Cervical Plate System · Blackstone Medical, Inc. · 2005 · recalledK030595 · Blackstone Fusion Anterior Cervical Plating System · Blackstone Medical, Inc. · 2003K012184 · Blackstone Iii Anterior Cervical Plating System · Blackstone Medical, Inc. · 2002K000486 · Abc Cervical Plating System · Aesculap, Inc. · 2000K990005 · Spinal Concepts, Inc. (Sci) Anterior Cervical Plate System · Spinal Concepts, Inc. · 1999 · recalledK922087 · Anterior Cervical Plate System · Sofamor Danek Mfg., Inc. · 1992−50
  1. Root · 8 generations backK922087 Anterior Cervical Plate SystemSofamor Danek Mfg., Inc. · 1992
  2. 7 generations backK990005 Spinal Concepts, Inc. (Sci) Anterior Cervical Plate SystemSpinal Concepts, Inc. · 1999 · Recalled
  3. 6 generations backK000486 Abc Cervical Plating SystemAesculap, Inc. · 2000
  4. 5 generations backK012184 Blackstone Iii Anterior Cervical Plating SystemBlackstone Medical, Inc. · 2002
  5. 4 generations backK030595 Blackstone Fusion Anterior Cervical Plating SystemBlackstone Medical, Inc. · 2003
  6. 3 generations backK050892 Hallmarktm Anterior Cervical Plate SystemBlackstone Medical, Inc. · 2005 · Recalled
  7. 2 generations backK100614 Hallmark Anterior Cervcial Plate System, Hallmark Five-Level…Blackstone Medical, Inc. · 2010
  8. 1 generation backK142060 Transom Anterior Cervical PlateNeurostructures, Inc. · 2014
  9. This deviceK171112 Trifore (tm) Cervical Plating SystemNeurostructures, Inc. · 2017
  10. Descendant · cites it directly · 0 of its ownK193494 Origin™ Anterior Cervical Plate SystemOrthopaedic & Spine Development · 2020

Most influential descendants

Showing 1 of 1 · See all
  • K193494Origin™ Anterior Cervical Plate SystemOrthopaedic & Spine Development · 2020 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−8K922087Anterior Cervical Plate SystemSofamor Danek Mfg., Inc.1992—
−7K990005Spinal Concepts, Inc. (Sci) Anterior Cervical Plate SystemSpinal Concepts, Inc.19991
−6K000486Abc Cervical Plating SystemAesculap, Inc.2000—
−5K012184Blackstone Iii Anterior Cervical Plating SystemBlackstone Medical, Inc.2002—
−4K030595Blackstone Fusion Anterior Cervical Plating SystemBlackstone Medical, Inc.2003—
−3K050892Hallmarktm Anterior Cervical Plate SystemBlackstone Medical, Inc.20052
−2K100614Hallmark Anterior Cervcial Plate System, Hallmark Five-Level Cervical PlatesBlackstone Medical, Inc.2010—
−1K142060Transom Anterior Cervical PlateNeurostructures, Inc.2014—
0 (this device)K171112Trifore (tm) Cervical Plating SystemNeurostructures, Inc.2017—
+1K193494Origin™ Anterior Cervical Plate SystemOrthopaedic & Spine Development2020—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199310
199510
199710
199840
199930
200020
200110
200320
200410
200610
200710
200810
201210
201310

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202010
FIG. 1 — Lineage of K171112, 1992–2020Source: 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? (4)

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
*K142060Transom Anterior Cervical Plate
Summary page 6
…for Use e Materials of manufacture e Principle of operation Table 5-1: Predicate Devices 510k Number Trade or Proprietary or Model Name | Manufacturer Predicate Type K142060 Transom™ Cervical Plating System NeuroStructures, Inc. | Primary K120515,K131374 | Tempus™ Cervical Plating System NeuroStructur…
Neurostructures, Inc.2014—
*K120515Tempus Cervical Plate System
Summary page 6
…redicate Devices 510k Number Trade or Proprietary or Model Name | Manufacturer Predicate Type K142060 Transom™ Cervical Plating System NeuroStructures, Inc. | Primary K120515,K131374 | Tempus™ Cervical Plating System NeuroStructures, Inc. | Additional K030866 CSLP System Synthes Additional PERFORMANCE…
Neurostructures, LLC2012—
*K131374Tempus (TM) Cervical Plate System
Summary page 6
…Devices 510k Number Trade or Proprietary or Model Name | Manufacturer Predicate Type K142060 Transom™ Cervical Plating System NeuroStructures, Inc. | Primary K120515,K131374 | Tempus™ Cervical Plating System NeuroStructures, Inc. | Additional K030866 CSLP System Synthes Additional PERFORMANCE DATA Th…
Neurostructures, LLC2013—
*K030866Synthes Anterior CSLP System
Summary page 6
…ate Type K142060 Transom™ Cervical Plating System NeuroStructures, Inc. | Primary K120515,K131374 | Tempus™ Cervical Plating System NeuroStructures, Inc. | Additional K030866 CSLP System Synthes Additional PERFORMANCE DATA The Trifore™ Cervical Plating System has been tested in the following test modes…
Synthes (Usa)2003—

Also cleared against K142060: 2 other devices →

What descends from it? (1)

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

NumberDeviceApplicantDecidedDescendants
K193494Origin™ Anterior Cervical Plate SystemOrthopaedic & Spine Development20200

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 25 years and passes through 5 companies; a new generation was cleared every 2.6 years on median.
  • 3 of the 29 ancestors have a recall of any class.
  • Of its descendants, K193494 (Orthopaedic & Spine Development, 2020) has gone furthest, with 0 descendants of its own.
  • 2 other devices also cite its predicate K142060.

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. 2017, 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 Trifore™ Cervical Plating System is intended for anterior cervical fixation (C2-T1) for the following indications: degenerative disc disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K142060

2 other devices cite the same predicate.

  • K200927Transept Cervical Plate SystemNeurostructures, Inc. · 2020
  • K173521SeaSpine Cabo ACP (Anterior Cervical Plate) SystemSeaSpine Orthopedics Corporation · 2018

More from Neurostructures, Inc.

15 FDA decisions under this applicant name. See the company

  • K200115Cavetto-SA Cervical Cage SystemNeurostructures, Inc. · 2020
  • K201769Cavetto [MAX] Cervical Cage SystemNeurostructures, Inc. · 2020
  • K200927Transept Cervical Plate SystemNeurostructures, Inc. · 2020
  • K192248Cortina™ [MAX] Lumbar Cage SystemNeurostructures, Inc. · 2019
  • K182195Arco™-SA Lumbar Cage SystemNeurostructures, Inc. · 2018

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/K171112 · printed Nov 6, 2026

Cite this page

510(k) Report. “K171112: Trifore (tm) Cervical Plating System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K171112

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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