510(k) Report

FDA applicant

Arrowhead De, LLC

Collierville, TN3 decisions2017–20200 recalls

FDA records 3 decisions for Arrowhead De, LLC (Collierville, TN) from 2017 to 2020: 3 510(k) clearances. All are in product code KTT (Appliance, Fixation, Nail/Blade/Plate…). Since 2016 its 510(k)s took a median of 214 days from receipt to decision, against 184 for FDA’s reviews in the same codes and years. Its devices cite 13 predicates, 1 of them its own earlier devices. No 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 Arrowhead De, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2020

2017: 12019: 12020: 1
2017high 1 (2017) · low 0 (2018)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2017.

FIG. 1 — Arrowhead De, LLC by year, 2017–2026Sources: 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

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 214 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 184 days; 0 of its 3 were faster than that.

Whose devices does it build on?

Its devices cite 13 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 4 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.

  • K190069SixFix™ Hexapod Fixator and Deformity Analysis and Correction Software (DACS)Arrowhead De, LLC · 20193cite it
  • K162032Arrowhead Mini-Rail FixatorArrowhead De, LLC · 20171cites it

What has FDA decided for it lately?

  • K200123Accessories for the SixFix® Hexapod FixatorArrowhead De, LLC · 2020
  • K190069SixFix™ Hexapod Fixator and Deformity Analysis and Correction Software (DACS)Arrowhead De, LLC · 2019
  • K162032Arrowhead Mini-Rail FixatorArrowhead De, LLC · 2017

All 3 as Arrowhead De, LLC →

Other applicant names beginning “Arrowhead”

FDA records each applicant name separately; these may or may not be the same firm.

Arrowhead Medical Device Technologies, LLC 2