510(k) Report

FDA applicant

Orthopedic Designs North America, Inc.

Tampa, FL4 decisions2011–20220 recalls

FDA records 4 decisions for Orthopedic Designs North America, Inc. (Tampa, FL) from 2011 to 2022: 4 510(k) clearances. Most are in product codes HSB (Rod, Fixation, Intramedullary And Accessories) and HWC (Screw, Fixation, Bone). Its devices cite 12 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 Orthopedic Designs North America, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2022

2011: 12015: 12018: 12022: 1
2011high 1 (2011) · low 0 (2012)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2011.

FIG. 1 — Orthopedic Designs North America, Inc. by year, 2011–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • HSBRod, Fixation, Intramedullary And Accessories3decisions
  • HWCScrew, Fixation, Bone1decision

Whose devices does it build on?

Its devices cite 12 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 2 times; 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.

  • K173255Talon DistalFix Humeral NailOrthopedic Designs North America, Inc. · 20181cites it
  • K111352Talon Distalfix Proximal Femoral NailOrthopedic Designs North America, Inc. · 20111cites it

What has FDA decided for it lately?

  • K210146Cannulated Compression Device SystemOrthopedic Designs North America, Inc. · 2022
  • K173255Talon DistalFix Humeral NailOrthopedic Designs North America, Inc. · 2018
  • K152295Talon DistalFix Antegrade/Retrograde Femoral NailOrthopedic Designs North America, Inc. · 2015
  • K111352Talon Distalfix Proximal Femoral NailOrthopedic Designs North America, Inc. · 2011

All 4 as Orthopedic Designs North America, Inc. →