510(k) Report

FDA applicant

Orthopedic Technology Research, Inc.

Hixson, TN2 decisions1996–19990 recalls

FDA records 2 decisions for Orthopedic Technology Research, Inc. (Hixson, TN) from 1996 to 1999: 2 510(k) clearances. All are in product code IRN (Device, Warning, Overload, External Limb…). Its devices cite 1 predicate, 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, physical medicine panel, where it files most

How often FDA has decided Orthopedic Technology Research, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Orthopedic Technology Research, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Orthopedic Technology Research, 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?

  • IRNDevice, Warning, Overload, External Limb, Powered2decisions

Whose devices does it build on?

Its devices cite 1 predicate; 0 are its own earlier devices. The firms it cites most:

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.

  • K991313Accutred ShoeOrthopedic Technology Research, Inc. · 19991cites it

What has FDA decided for it lately?

  • K991313Accutred ShoeOrthopedic Technology Research, Inc. · 1999
  • K960307Index ShoeOrthopedic Technology Research, Inc. · 1996

All 2 as Orthopedic Technology Research, Inc. →