FDA applicant

American Ortomed Corp.

Mchenry, IL6 decisions1978–19850 recalls

FDA records 6 decisions for American Ortomed Corp. (Mchenry, IL) from 1978 to 1985: 6 510(k) clearances. Most are in product codes KWA (Prosthesis, Hip, Semi-Constrained (Metal…) and JDG (Prosthesis, Hip, Femoral Component, Cemented…). 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 American Ortomed Corp.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for American Ortomed Corp. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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American Ortomed Corp.

Which product codes does it file in?

What has FDA decided for it lately?