510(k) Report

FDA applicant

Orthodyne, Inc.

Orlando, FL1 decision2001–20011 recall

FDA records 1 decision for Orthodyne, Inc. (Orlando, FL) in 2001: 1 510(k) clearance. All are in product code HSB (Rod, Fixation, Intramedullary And Accessories). Its devices cite 2 predicates, 0 of them its own earlier devices. 1 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 Orthodyne, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Orthodyne, Inc. since 2007.

Recalls per year

1in 2012

2012: 1
2007high 1 (2012) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Orthodyne, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • HSBRod, Fixation, Intramedullary And Accessories1decision

Whose devices does it build on?

Its devices cite 2 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 4 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.

  • K010322Iskd (Intramedullary Skeletal Kinetic Distractor)Orthodyne, Inc. · 20014cite it

What has FDA decided for it lately?

  • K010322Iskd (Intramedullary Skeletal Kinetic Distractor)Orthodyne, Inc. · 20011 recall

The one decision as Orthodyne, Inc. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K010322Orthofix ISKD Limb Lengthener. ISKD - Intramedullary Skeletal Kinetic Distractor. The…Aug 6, 2012Class II