510(k) Report

FDA applicant

Harmos Orthopaedics, Inc.

Cantonville, MD1 decision2002–20020 recalls

FDA records 1 decision for Harmos Orthopaedics, Inc. (Cantonville, MD) in 2002: 1 510(k) clearance. All are in product code KWD (Prosthesis, Toe, Hemi-, Phalangeal). 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 Harmos Orthopaedics, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Harmos Orthopaedics, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Which product codes does it file in?

  • KWDProsthesis, Toe, Hemi-, Phalangeal1decision

Who builds on its devices?

Later devices cite its devices 1 time; 0 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.

  • K014164Great Toe Implant SystemHarmos Orthopaedics, Inc. · 20021cites it

What has FDA decided for it lately?

  • K014164Great Toe Implant SystemHarmos Orthopaedics, Inc. · 2002

The one decision as Harmos Orthopaedics, Inc. →