510(k) Report

FDA applicant

Auxano Medical, LLC

Brecksville, OH2 decisions2023–20250 recalls

FDA records 2 decisions for Auxano Medical, LLC (Brecksville, OH) from 2023 to 2025: 2 510(k) clearances. Most are in product codes HWC (Screw, Fixation, Bone) and PLF (Bone Wedge). Its devices cite 5 predicates, 0 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 Auxano Medical, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2023: 12025: 1
2023high 1 (2023) · low 0 (2024)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2023.

FIG. 1 — Auxano Medical, LLC by year, 2023–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • HWCScrew, Fixation, Bone1decision
  • PLFBone Wedge1decision

Whose devices does it build on?

Its devices cite 5 predicates; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K251791Auxano® Wedge Fixation SystemAuxano Medical, LLC · 2025
  • K231649Intraosseous Fusion Device SystemAuxano Medical, LLC · 2023

All 2 as Auxano Medical, LLC →