510(k) Report

510(k) · Cleared

Cleared

Tempus (TM) Cervical Plate System

K131374510(k) TraditionalCleared Aug 23, 2013102-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, LLC · KWQ Appliance, Fixation, Spinal Intervertebral Body

Cleared on Aug 23, 2013 as substantially equivalent to K120515 (Neurostructures, LLC, 2012) after a 102-day review. Its family tree reaches back 3 generations to 1998. 22 later devices descend from it.

Decided
Aug 23, 2013
Review
102 days
Class
Class II
Product code
KWQ
Recalls
None
Predicates
1

Its longest line of descent runs back 3 generations to K974435 (1998). 4 ancestors in all. 22 later devices descend from it, 4 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2003: 1 other ancestor2017: 1 descendant cleared2020: 4 descendants cleared2014: 1 descendant cleared2018: 1 descendant cleared2021: 3 descendants cleared2024: 1 descendant cleared2025: 6 descendants cleared2026: 5 descendants clearedK974435 · Michelson Anterior Cervical Plate System · Wrightmedicaltechnologyinc · 1998K012305 · Modification to: Trinica Anterior Cervical Plate System · Sulzer Spine-Tech · 2001K120515 · Tempus Cervical Plate System · Neurostructures, LLC · 20121995200020052010201520202025
Other ancestors, by generationDescendants, by generation 2 generations back: 1 other ancestor 1 generation forward: 4 descendants2 generations forward: 3 descendants3 generations forward: 5 descendants4 generations forward: 4 descendants5 generations forward: 5 descendants6 generations forward: 1 descendant K120515 · Tempus Cervical Plate System · Neurostructures, LLC · 2012K012305 · Modification to: Trinica Anterior Cervical Plate System · Sulzer Spine-Tech · 2001K974435 · Michelson Anterior Cervical Plate System · Wrightmedicaltechnologyinc · 19980+5
  1. Root · 3 generations backK974435 Michelson Anterior Cervical Plate SystemWrightmedicaltechnologyinc · 1998
  2. 2 generations backK012305 Modification to: Trinica Anterior Cervical Plate SystemSulzer Spine-Tech · 2001
  3. 1 generation backK120515 Tempus Cervical Plate SystemNeurostructures, LLC · 2012
  4. This deviceK131374 Tempus (TM) Cervical Plate SystemNeurostructures, LLC · 2013
  5. Descendant · cites it directly · 19 of its ownK142060 Transom Anterior Cervical PlateNeurostructures, Inc. · 2014
  6. Descendant · 2 generations on · 15 of its ownK173521 SeaSpine Cabo ACP (Anterior Cervical Plate) SystemSeaSpine Orthopedics Corporation · 2018
  7. Descendant · 3 generations on · 14 of its ownK202064 Admiral ACP SystemSeaSpine Orthopedics Corporation · 2020
  8. Descendant · 3 generations on · 7 of its ownK211903 Shoreline Threaded TruProfile® PlateSeaSpine Orthopedics Corporation · 2021
  9. Descendant · cites it directly · 7 of its ownK200995 Insignia™ Anterior Cervical Plate SystemAlphatec Spine, Inc. · 2020 · Recalled

Showing 5 of 22 descendants. See all descendants

Descendants cleared per year

2014: 12017: 12018: 12020: 42021: 32024: 12025: 62026: 5
2014high 6 (2025) · low 0 (2015)2026

Most influential descendants

Showing 5 of 22 · See all
  • K142060Transom Anterior Cervical PlateNeurostructures, Inc. · 2014 · cites it directly19descendants
  • K173521SeaSpine Cabo ACP (Anterior Cervical Plate) SystemSeaSpine Orthopedics Corporation · 2018 · 2 generations on15descendants
  • K202064Admiral ACP SystemSeaSpine Orthopedics Corporation · 2020 · 3 generations on14descendants
  • K211903Shoreline Threaded TruProfile® PlateSeaSpine Orthopedics Corporation · 2021 · 3 generations on7descendants
  • K200995Insignia™ Anterior Cervical Plate SystemAlphatec Spine, Inc. · 2020 · cites it directly7descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K974435Michelson Anterior Cervical Plate SystemWrightmedicaltechnologyinc1998—
−2K012305Modification to: Trinica Anterior Cervical Plate SystemSulzer Spine-Tech2001—
−1K120515Tempus Cervical Plate SystemNeurostructures, LLC2012—
0 (this device)K131374Tempus (TM) Cervical Plate SystemNeurostructures, LLC2013—
+1K142060Transom Anterior Cervical PlateNeurostructures, Inc.2014—
+2K173521SeaSpine Cabo ACP (Anterior Cervical Plate) SystemSeaSpine Orthopedics Corporation2018—
+3K202064Admiral ACP SystemSeaSpine Orthopedics Corporation2020—
+3K211903Shoreline Threaded TruProfile® PlateSeaSpine Orthopedics Corporation2021—
+1K200995Insignia™ Anterior Cervical Plate SystemAlphatec Spine, Inc.202029

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200310

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201410
201710
201810
202040
202130
202410
202560
202650
FIG. 1 — Lineage of K131374, 1998–2026Source: 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? (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
*K120515Tempus Cervical Plate System
Summary page 1
…W Classification Panel: ---- O[rthopedic and Rehabilitation Devices Panel Pedicate evcs JemusTM Cervical Plate System (K 12051 5) DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION: The Tempus T M Cervical Plate System consists of screws and plate…
Neurostructures, LLC2012—

Also cleared against K120515: 3 other devices →

What descends from it? (22)

See all 22

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

NumberDeviceApplicantDecidedDescendants
K142060Transom Anterior Cervical PlateNeurostructures, Inc.201419
K200995Insignia™ Anterior Cervical Plate SystemAlphatec Spine, Inc.20207
K171112Trifore (tm) Cervical Plating SystemNeurostructures, Inc.20171
K200927Transept Cervical Plate SystemNeurostructures, Inc.20200

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 15 years and passes through 3 companies; a new generation was cleared every 3.5 years on median.
  • None of the 4 ancestors has a recall.
  • Of its descendants, K142060 (Neurostructures, Inc., 2014) has gone furthest, with 19 descendants of its own.
  • 3 other devices also cite its predicate K120515.

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. 2013, 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 TempusTM Cervical Plate System is intended for anterior cervical fixation (C2-TI) for the following indications: degenerative disc disease (DDD) (defined as neck pain ofdiscogenic origin with degeneration of the disc confirmed by history and radiographic studies), sporidylolisthesis, 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 as stated in the FDA summary.

Also cleared against K120515

3 other devices cite the same predicate.

  • K200927Transept Cervical Plate SystemNeurostructures, Inc. · 2020
  • K171112Trifore (tm) Cervical Plating SystemNeurostructures, Inc. · 2017
  • K142060Transom Anterior Cervical PlateNeurostructures, Inc. · 2014

More from Neurostructures, LLC

3 FDA decisions under this applicant name. See the company

  • K121551Resolute Facet Screw SystemNeurostructures, LLC · 2012
  • K120515Tempus Cervical Plate SystemNeurostructures, LLC · 2012

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/K131374 · printed Nov 6, 2026

Cite this page

510(k) Report. “K131374: Tempus (TM) Cervical 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/K131374

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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