510(k) Report

FDA applicant

Dne, LLC

Round Rock, TX3 decisions2012–20161 recall

FDA records 3 decisions for Dne, LLC (Round Rock, TX) from 2012 to 2016: 3 510(k) clearances. All are in product code KTT (Appliance, Fixation, Nail/Blade/Plate…). Its devices cite 7 predicates, 1 of them its own earlier devices. 1 recall is linked to its devices.

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 Dne, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2016

2012: 12014: 12016: 1
2012high 1 (2012) · low 0 (2013)2026

2026 so far, outlined.

Recalls per year

1in 2025

2025: 1
2012high 1 (2025) · low 0 (2012)2026

Class I Class II/III not classified

FIG. 1 — Dne, LLC by year, 2012–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • KTTAppliance, Fixation, Nail/Blade/Plate Combination, Multiple Component3decisions

Whose devices does it build on?

Its devices cite 7 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 2 times; 1 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.

  • K113106Dne External Fixation SystemDne, LLC · 20122cite it

What has FDA decided for it lately?

  • K151580D.N.E. External Fixation SystemDne, LLC · 20161 recall
  • K140158S.E.a.L. Fracture Fusion TubeDne, LLC · 2014
  • K113106Dne External Fixation SystemDne, LLC · 2012

All 3 as Dne, LLC →

What has been recalled?

1 recall linked to its devices; the latest:

  • K151580Medshape Universal Joints, REF: DNE-9000-UJJun 2, 2025Class II