FDA applicant
Orthofix, Inc.
FDA records 100 decisions for Orthofix, Inc. (Lewisville, TX) from 1986 to 2026: 98 510(k) clearances and 2 original PMA approvals. Most are in product codes HSB (Rod, Fixation, Intramedullary And Accessories) and KTT (Appliance, Fixation, Nail/Blade/Plate…). Since 2016 its 510(k)s took a median of 86 days from receipt to decision, against 107 for FDA’s reviews in the same codes and years. Its devices cite 218 predicates, 84 of them its own earlier devices. 57 recalls are linked to its devices.
FDA’s records also spell it “Orthofix Srl”, “Orthofix”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Orthofix, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2025
2026 so far, outlined.
Recalls per year
4in 2026
Class I Class II/III not classified
Planning a device like Orthofix, 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) ReportOther applicant names beginning “Orthofix”
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