FDA applicant

Aptis Medical, LLC

Glenview, KY5 decisions2005–20190 recalls

FDA records 5 decisions for Aptis Medical, LLC (Glenview, KY) from 2005 to 2019: 5 510(k) clearances. All are in product code KXE (Prosthesis, Wrist, Hemi-, Ulnar). Its devices cite 6 predicates, 6 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 Aptis Medical, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2019

2007high 1 (2008) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Aptis Medical, LLC by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Aptis Medical, LLC

Which product codes does it file in?

Which of its devices are cited most?

What has FDA decided for it lately?