510(k) Report

FDA applicant

Akros Medical

Durham, NC3 decisions2017–20200 recalls

FDA records 3 decisions for Akros Medical (Durham, NC) from 2017 to 2020: 3 510(k) clearances. All are in product code HTN (Washer, Bolt Nut). Since 2016 its 510(k)s took a median of 52 days from receipt to decision, against 88 for FDA’s reviews in the same codes and years. Its devices cite 4 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 Akros Medical’s devices, and how often a recall has named them.

FDA decisions per year

1in 2020

2017: 22020: 1
2017high 2 (2017) · low 0 (2018)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2017.

FIG. 1 — Akros Medical by year, 2017–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Akros Medical’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?

  • HTNWasher, Bolt Nut3decisions

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 52 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 88 days; 2 of its 3 were faster than that.

Whose devices does it build on?

Its devices cite 4 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.

  • K173550Akros FibuLink™ Syndesmosis Repair KitAkros Medical · 20171cites it
  • K162805Akros Fibulink Syndesmosis Repair KitAkros Medical · 20171cites it

What has FDA decided for it lately?

  • K200361Akros Scruture Anchor LisFranc Repair KitAkros Medical · 2020
  • K173550Akros FibuLink™ Syndesmosis Repair KitAkros Medical · 2017
  • K162805Akros Fibulink Syndesmosis Repair KitAkros Medical · 2017

All 3 as Akros Medical →