FDA applicant

Orthopaedic Designs, Inc.

Alexandria, VA2 decisions1988–19970 recalls

FDA records 2 decisions for Orthopaedic Designs, Inc. (Alexandria, VA) from 1988 to 1997: 2 510(k) clearances. Most are in product codes HSB (Rod, Fixation, Intramedullary And Accessories) and KTT (Appliance, Fixation, Nail/Blade/Plate…). Its devices cite 10 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 Orthopaedic Designs, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Orthopaedic Designs, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Orthopaedic Designs, Inc.

Which product codes does it file in?

Whose devices does it build on?

What has FDA decided for it lately?