510(k) Report

FDA applicant

Dunamis, LLC

Greenville, AL6 decisions2015–20200 recalls

FDA records 6 decisions for Dunamis, LLC (Greenville, AL) from 2015 to 2020: 6 510(k) clearances. Most are in product codes MBI (Fastener, Fixation, Nondegradable, Soft Tissue) and GAT (Suture, Nonabsorbable, Synthetic, Polyethylene). Since 2016 its 510(k)s took a median of 85 days from receipt to decision, against 92 for FDA’s reviews in the same codes and years. Its devices cite 14 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 Dunamis, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2020

2015: 22016: 22019: 12020: 1
2015high 2 (2015) · low 0 (2017)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2015.

FIG. 1 — Dunamis, LLC by year, 2015–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • MBIFastener, Fixation, Nondegradable, Soft Tissue4decisions
  • GATSuture, Nonabsorbable, Synthetic, Polyethylene2decisions

How long do its 510(k) reviews take?

Since 2016, its 4 510(k)s took a median of 85 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 92 days; 3 of its 4 were faster than that.

Whose devices does it build on?

Its devices cite 14 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.

  • K160996Dunamis Suture Anchor PEEK 3.0mm, 3.5mm, 4.5mm, 5.5mm, 6.5mmDunamis, LLC · 20161cites it
  • K191319Dunamis Fixation Button SystemDunamis, LLC · 20191cites it

What has FDA decided for it lately?

  • K193245Dunamis PunchTac Suture AnchorsDunamis, LLC · 2020
  • K191319Dunamis Fixation Button SystemDunamis, LLC · 2019
  • K160996Dunamis Suture Anchor PEEK 3.0mm, 3.5mm, 4.5mm, 5.5mm, 6.5mmDunamis, LLC · 2016
  • K153746Dunamis Force DFX Tensile TapeDunamis, LLC · 2016
  • K151220Dunamis Interference ScrewDunamis, LLC · 2015
  • K150327Dunamis Force DFX Suture, Size 5, Dunamis Force DFX Suture Size 2Dunamis, LLC · 2015

All 6 as Dunamis, LLC →

Other applicant names beginning “Dunamis”

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

Dunamis Medical, LLC 1