510(k) Report

FDA applicant

Trans1 Incorporated

Wilmington, NC14 decisions2004–20190 recalls

FDA records 14 decisions for Trans1 Incorporated (Wilmington, NC) from 2004 to 2019: 14 510(k) clearances. Most are in product codes KWQ (Appliance, Fixation, Spinal Intervertebral Body) and MAX (Intervertebral Fusion Device With Bone Graft…). Its devices cite 17 predicates, 9 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Trans1, Inc.”, “Trans1”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, orthopedic panel, where it files most

How often FDA has decided Trans1 Incorporated’s devices, and how often a recall has named them.

FDA decisions per year

2in 2019

2008: 32010: 22011: 12012: 12013: 12019: 2
2007high 3 (2008) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Trans1 Incorporated by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Trans1 Incorporated’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • KWQAppliance, Fixation, Spinal Intervertebral Body7decisions
  • MAXIntervertebral Fusion Device With Bone Graft, Lumbar4decisions
  • MRWSystem, Facet Screw Spinal Device2decisions
  • HRXArthroscope1decision

Whose devices does it build on?

Its devices cite 17 predicates; 9 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 31 times; 9 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K073515TRANS1 Facet ScrewTrans1 Incorporated · 200811cite it
  • K032891TRANS1 Trans-Sacral Spinal Access and Preparation KitTrans1, Inc. · 20043cite it
  • K100210TRANS1 Lateral Intervertebral Fusion Device, TTrans1 Incorporated · 20103cite it
  • K120991TRANS1 Interbody Fusion SystemTrans1 Incorporated · 20123cite it
  • K040426TRANS1 Axial Fixation SystemTrans1, Inc. · 20042cite it
  • K123997TRANS1LATERAL Interbody Fusion SystemTrans1, Inc. · 20132cite it

What has FDA decided for it lately?

  • K192792TranS1 AxiaLIF Plus SystemTrans1 · 2019
  • K191791TranS1 Interbody Fusion SystemTrans1 · 2019
  • K123997TRANS1LATERAL Interbody Fusion SystemTrans1, Inc. · 2013
  • K120991TRANS1 Interbody Fusion SystemTrans1 Incorporated · 2012
  • K102334TRANS1 Axialif PlusTrans1 Incorporated · 2011
  • K100210TRANS1 Lateral Intervertebral Fusion Device, TTrans1 Incorporated · 2010
  • K092124Axialif 2L, Axialif 2-Level System, Axialif Apollo, Axialif IITrans1 Incorporated · 2010
  • K073643TRANS1 Axialif 2-Level or II SystemTrans1 Incorporated · 2008

All 9 as Trans1 Incorporated →All 3 as Trans1, Inc. →All 2 as Trans1 →