FDA applicant
Ortho Development Corp.
FDA records 64 decisions for Ortho Development Corp. (Draper, UT) from 1996 to 2025: 64 510(k) clearances. Most are in product codes JWH (Prosthesis, Knee, Patellofemorotibial…) and LPH (Prosthesis, Hip, Semi-Constrained…). Since 2016 its 510(k)s took a median of 98 days from receipt to decision, against 90 for FDA’s reviews in the same codes and years. Its devices cite 107 predicates, 36 of them its own earlier devices. 26 recalls are linked to its devices.
FDA’s records also spell it “Ortho Development Corporation”, “Ortho Development”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Ortho Development Corp.’s devices, and how often a recall has named them.
FDA decisions per year
2in 2025
2026 so far, outlined.
Recalls per year
2in 2019
Class I Class II/III not classified
Planning a device like Ortho Development 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 “Ortho”
FDA records each applicant name separately; these may or may not be the same firm.