510(k) Report

FDA applicant

Biomechanic, Inc.

Creve Coeur, MO1 decision1995–19950 recalls

FDA records 1 decision for Biomechanic, Inc. (Creve Coeur, MO) in 1995: 1 510(k) clearance. All are in product code JDQ (Cerclage, Fixation). 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 Biomechanic, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Biomechanic, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Biomechanic, 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?

  • JDQCerclage, Fixation1decision

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.

  • K951844Biomechanic Low-Profile Cable SystemBiomechanic, Inc. · 19951cites it

What has FDA decided for it lately?

  • K951844Biomechanic Low-Profile Cable SystemBiomechanic, Inc. · 1995

The one decision as Biomechanic, Inc. →