510(k) Report

510(k) · Cleared

Cleared

Transcorp Trans-Plate Anterior Cervical Plate System

K092695510(k) TraditionalCleared May 21, 2010261-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

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

Cleared on May 21, 2010 as substantially equivalent to K030866 (Synthes (Usa), 2003) and 1 other predicate after a 261-day review. Its family tree reaches back 1 generation to 2002.

Decided
May 21, 2010
Review
261 days
Class
Class II
Product code
KWQ
Recalls
None
Predicates
2

Its longest line of descent runs back 1 generation to K021461 (2002). 2 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 2003: 1 other ancestorK021461 · Atlantis Vision Anterior Cervical Plate System · Medtronic Sofamor Danek · 2002 · recalled2000200220042006200820102012
Other ancestors, by generation 1 generation back: 1 other ancestor K021461 · Atlantis Vision Anterior Cervical Plate System · Medtronic Sofamor Danek · 2002 · recalled0
  1. Root · 1 generation backK021461 Atlantis Vision Anterior Cervical Plate SystemMedtronic Sofamor Danek · 2002 · Recalled
  2. This deviceK092695 Transcorp Trans-Plate Anterior Cervical Plate SystemTranscorp, Inc. · 2010
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K021461Atlantis Vision Anterior Cervical Plate SystemMedtronic Sofamor Danek20023
0 (this device)K092695Transcorp Trans-Plate Anterior Cervical Plate SystemTranscorp, Inc.2010—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200310
FIG. 1 — Lineage of K092695, 2002–2010Source: 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? (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
*K030866Synthes Anterior CSLP System
Summary page 1
…sification: 21 CFR Section 888.3060, Product Code KWQ, Class 11 Predicate Devices: K030866 Synthes CSLP K021461 Medtronic Atlantis Cervical Plate System Device Description: The…
Synthes (Usa)2003—
*K021461Atlantis Vision Anterior Cervical Plate System
Summary page 1
…Product Code KWQ, Class 11 Predicate Devices: K030866 Synthes CSLP K021461 Medtronic Atlantis Cervical Plate System Device Description: The Transcorp Trans-Plate Anterior Cervical Plate System i…
Medtronic Sofamor Danek20023

Also cleared against K030866: 41 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?

  • 1 of the 2 ancestors has a recall of any class.
  • 41 other devices also cite its predicate K030866.

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. 2010, 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 Transcorp Trans-Plate Anterior Cervical Plate System is intended for anterior screw fixation of the cervical spine (C2-C7). These implants have been designed to provide stabilization to cervical fusion. Indications for the use of this implant system include degenerative disc disease (defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or…

Read the full statement (110 words)

The Transcorp Trans-Plate Anterior Cervical Plate System is intended for anterior screw fixation of the cervical spine (C2-C7). These implants have been designed to provide stabilization to cervical fusion. Indications for the use of this implant system include degenerative disc disease (defined as neck pain of discogenic origin with the 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, pseudarthrosis, or failed previous fusion.

WARNING: The Transcorp Trans-Plate Anterior Cervical Plate System in not intended for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic or lumbar spine.

Indications for use as stated in the FDA summary.

Also cleared against K030866

41 other devices cite the same predicate.

  • K231251FlexWing Anterior Cervical Plate SystemJeil Medical Corporation · 2024
  • K201587icotec Anterior Cervical Plate SystemIcotec AG · 2020
  • K200883CarboClear® Cervical Plate SystemCarboFix Orthopedics, Ltd. · 2020
  • K192049Oryx Cervical Plate SystemInnovasis, Inc. · 20191 recall
  • K191500NuVasive® ACP SystemNu Vasive, Incorporated · 2019
  • K191786Cyclops™ Anterior Cervical Plate SystemDegen Medical, Inc. · 2019

More from Transcorp, Inc.

4 FDA decisions under this applicant name. See the company

  • K121178Transcorp Acif SystemTranscorp, Inc. · 2013
  • K113352Transcorp Spinal Access SystemTranscorp, Inc. · 2012
  • K092794Transcorp Acif SystemTranscorp, Inc. · 2010

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/K092695 · printed Nov 4, 2026

Cite this page

510(k) Report. “K092695: Transcorp Trans-Plate Anterior Cervical 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/K092695

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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