510(k) Report

FDA applicant

ArthroTAK, LLC

Missoula, MT2 decisions2026–20260 recalls

FDA records 2 decisions for ArthroTAK, LLC (Missoula, MT) in 2026: 2 510(k) clearances. All are in product code MBI (Fastener, Fixation, Nondegradable, Soft Tissue). 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 ArthroTAK, LLC’s devices, and how often a recall has named them.

FDA decisions per year

2in 2026

2026 (partial year): 2
2026high 2 (2026)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2026.

FIG. 1 — ArthroTAK, LLC by year, 2026–2026Sources: 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 Tissue2decisions

Whose devices does it build on?

Its devices cite 4 predicates; 1 are its own earlier devices. The firms it cites most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K252635ArthroTAK Tendon Anchor KitArthroTAK, LLC · 20261cites it

What has FDA decided for it lately?

  • K262809ArthroTAK Tendon Anchor KitArthroTAK, LLC · 2026
  • K252635ArthroTAK Tendon Anchor KitArthroTAK, LLC · 2026

All 2 as ArthroTAK, LLC →