FDA applicant
DePuy Synthes
FDA records 20 decisions for DePuy Synthes (West Chester, PA) from 1979 to 2024: 20 510(k) clearances. Most are in product codes HRS (Plate, Fixation, Bone) and OLO (Orthopedic Stereotaxic Instrument). Since 2016 its 510(k)s took a median of 89 days from receipt to decision, against 90 for FDA’s reviews in the same codes and years. Its devices cite 95 predicates, 3 of them its own earlier devices. 1 recall is linked to its devices.
FDA’s records also spell it “Depuy Synthes, Inc.”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided DePuy Synthes’s devices, and how often a recall has named them.
FDA decisions per year
5in 2024
2026 so far, outlined.
Recalls per year
1in 2024
Class I Class II/III not classified
Planning a device like DePuy Synthes’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 “DePuy”
FDA records each applicant name separately; these may or may not be the same firm.