FDA applicant
OrthoPediatrics Corp.
FDA records 45 decisions for OrthoPediatrics Corp. (Warsaw, IN) from 2008 to 2026: 45 510(k) clearances. Most are in product codes HRS (Plate, Fixation, Bone) and HSB (Rod, Fixation, Intramedullary And Accessories). Since 2016 its 510(k)s took a median of 112 days from receipt to decision, against 91 for FDA’s reviews in the same codes and years. Its devices cite 144 predicates, 47 of them its own earlier devices. 46 recalls are linked to its devices.
FDA’s records also spell it “Orthopediatrics, LLC”, “Orthopediatrics, Inc.”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided OrthoPediatrics Corp.’s devices, and how often a recall has named them.
FDA decisions per year
6in 2025
2026 so far, outlined.
Recalls per year
2in 2020
Class I Class II/III not classified
Planning a device like OrthoPediatrics Corp.’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 “OrthoPediatrics”
FDA records each applicant name separately; these may or may not be the same firm.