510(k) Report

510(k) · Cleared

Cleared

Transept Cervical Plate System

K200927510(k) TraditionalCleared Jul 24, 2020108-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 Jul 24, 2020 as substantially equivalent to K142060 (Neurostructures, Inc., 2014) and 5 other predicates after a 108-day review. Its family tree reaches back 8 generations to 1992.

Decided
Jul 24, 2020
Review
108 days
Class
Class II
Product code
KWQ
Recalls
None
Predicates
6

Its longest line of descent runs back 8 generations to K922087 (1992). 57 ancestors in all, the oldest K792352 (1979). No later device cites it as a predicate yet.

Other ancestors, by year cleared 2015: 1 other ancestor2014: 1 other ancestor2013: 2 other ancestors2012: 1 other ancestor2011: 2 other ancestors2008: 2 other ancestors2004: 6 other ancestors2003: 3 other ancestors2002: 2 other ancestors2001: 2 other ancestors1998: 4 other ancestors1997: 2 other ancestors2007: 5 other ancestors2006: 2 other ancestors2000: 4 other ancestors1995: 2 other ancestors1994: 1 other ancestor1993: 1 other ancestor1992: 1 other ancestor2005: 1 other ancestor1999: 3 other ancestors1979: 1 other ancestorK922087 · 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. · 201419801990200020102020
Other ancestors, by generation 1 generation back: 5 other ancestors2 generations back: 9 other ancestors3 generations back: 16 other ancestors4 generations back: 12 other ancestors5 generations back: 4 other ancestors6 generations back: 3 other ancestors 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 deviceK200927 Transept Cervical Plate SystemNeurostructures, Inc. · 2020
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)K200927Transept Cervical Plate SystemNeurostructures, Inc.2020—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
197910
199210
199310
199410
199520
199720
199840
199930
200040
200120
200220
200330
200460
200510
200620
200750
200820
201120
201210
201320
201410
201510
FIG. 1 — Lineage of K200927, 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? (6)

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 4
…e from titanium alloy (Ti-6Al-4V ELI) per ASTM F136. The indications for use for the Transept™ Cervical Plate System are the same as the Transom™ Cervical Plate System (K142060). INDICATIONS FOR USE The Transept™ Cervical Plate System is intended for anterior cervical fixation (C2-T1) for the following i…
Neurostructures, Inc.2014—
*K131374Tempus (TM) Cervical Plate System
Summary page 5
…Name Type K142060 Transom™ Cervical Plate System NeuroStructures, Inc. Primary K131374, K120515 Tempus™ Cervical Plate System NeuroStructures, Inc. Additional K133518 MaxAn®…
Neurostructures, LLC2013—
*K120515Tempus Cervical Plate System
Summary page 5
…e Type K142060 Transom™ Cervical Plate System NeuroStructures, Inc. Primary K131374, K120515 Tempus™ Cervical Plate System NeuroStructures, Inc. Additional K133518 MaxAn® Anterior…
Neurostructures, LLC2012—
*K133518Maxan Anterior Cervical Plate System
Summary page 5
…Transom™ Cervical Plate System NeuroStructures, Inc. Primary K131374, K120515 Tempus™ Cervical Plate System NeuroStructures, Inc. Additional K133518 MaxAn® Anterior Cervical Plate Biomet Spine, LLC Additional System…
Biomet Spine (Aka Ebi, LLC)20141
*K111796Invizia Anterior Cervical Plate System
Summary page 5
…Structures, Inc. Additional K133518 MaxAn® Anterior Cervical Plate Biomet Spine, LLC Additional System K111796 inViZia® Anterior Cervical Plate Zimmer Spine, Inc. Additional System…
Zimmer Spine, Inc.2011—
*K150666uNion Cervical Plate System
Summary page 5
…System K111796 inViZia® Anterior Cervical Plate Zimmer Spine, Inc. Additional System K150666 uNion™ Cervical Plate System Ulrich medical USA, Additional…
Ulrich Medical USA20151

Also cleared against K142060: 2 other devices →

What descends from it?

No later submission names this one as a predicate yet.

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 28 years and passes through 5 companies; a new generation was cleared every 4.5 years on median.
  • 11 of the 57 ancestors have a recall of any class.
  • 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. 2020, 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 Transept™ Cervical Plate 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 as stated in the FDA summary.

Also cleared against K142060

2 other devices cite the same predicate.

  • K173521SeaSpine Cabo ACP (Anterior Cervical Plate) SystemSeaSpine Orthopedics Corporation · 2018
  • K171112Trifore (tm) Cervical Plating SystemNeurostructures, Inc. · 2017

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
  • K192248Cortina™ [MAX] Lumbar Cage SystemNeurostructures, Inc. · 2019
  • K182195Arco™-SA Lumbar Cage SystemNeurostructures, Inc. · 2018
  • K181590Neurostructures Cavetto® [MAX] Cervical 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/K200927 · printed Nov 6, 2026

Cite this page

510(k) Report. “K200927: Transept 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/K200927

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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