510(k) Report

FDA applicant

Orthopedic Designs, Inc.

St. Petersburg, FL4 decisions1998–20030 recalls

FDA records 4 decisions for Orthopedic Designs, Inc. (St. Petersburg, FL) from 1998 to 2003: 4 510(k) clearances. Most are in product codes HWC (Screw, Fixation, Bone) and HTN (Washer, Bolt Nut). Its devices cite 17 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, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

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

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Orthopedic Designs, 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?

  • HWCScrew, Fixation, Bone2decisions
  • HTNWasher, Bolt Nut1decision
  • JDSNail, Fixation, Bone1decision

Whose devices does it build on?

Its devices cite 17 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 3 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.

  • K014189Odi Talon Intramedullary Hip NailOrthopedic Designs, Inc. · 20022cite it
  • K984331Odi Ultimate Compression Hip ScrewOrthopedic Designs, Inc. · 19991cites it

What has FDA decided for it lately?

  • K030619Odi 7.0MM Cannulated Screw SystemOrthopedic Designs, Inc. · 2003
  • K014189Odi Talon Intramedullary Hip NailOrthopedic Designs, Inc. · 2002
  • K984331Odi Ultimate Compression Hip ScrewOrthopedic Designs, Inc. · 1999
  • K972722Ultimate Compression Screw SystemOrthopedic Designs, Inc. · 1998

All 4 as Orthopedic Designs, Inc. →