510(k) Report

FDA applicant

Arrowhead Medical Device Technologies, LLC

Collierville, TN2 decisions2011–20181 recall

FDA records 2 decisions for Arrowhead Medical Device Technologies, LLC (Collierville, TN) from 2011 to 2018: 2 510(k) clearances. Most are in product codes OSN (Software For Diagnosis/Treatment) and HTY (Pin, Fixation, Smooth). Its devices cite 9 predicates, 0 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 Arrowhead Medical Device Technologies, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2018

2011: 12018: 1
2011high 1 (2011) · low 0 (2012)2026

2026 so far, outlined.

Recalls per year

1in 2026

2026 (partial year): 1
2011high 1 (2026) · low 0 (2011)2026

Class I Class II/III not classified

FIG. 1 — Arrowhead Medical Device Technologies, LLC by year, 2011–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • OSNSoftware For Diagnosis/Treatment1decision
  • HTYPin, Fixation, Smooth1decision

Whose devices does it build on?

Its devices cite 9 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 4 times; 0 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.

  • K112675Arrow-Lok Digital SystemArrowhead Medical Device Technologies, LLC · 20113cite it
  • K180539Deformity Analysis and Correction Software (DACS) and InstrumentationArrowhead Medical Device Technologies, LLC · 20181cites it

What has FDA decided for it lately?

  • K180539Deformity Analysis and Correction Software (DACS) and InstrumentationArrowhead Medical Device Technologies, LLC · 2018
  • K112675Arrow-Lok Digital SystemArrowhead Medical Device Technologies, LLC · 20111 recall

All 2 as Arrowhead Medical Device Technologies, LLC →

What has been recalled?

1 recall linked to its devices; the latest:

  • K112675Arrow-LOK Implant, REF: 21-253519, 21-253522, 21-253525, 21-253528, 21-253530…Jun 23, 2026Class II

Other applicant names beginning “Arrowhead”

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

Arrowhead De, LLC 3