FDA applicant
Depuy (Ireland)
FDA records 13 decisions for Depuy (Ireland) (Cork, IE) from 2010 to 2022: 13 510(k) clearances. Most are in product codes PHX (Shoulder Prosthesis, Reverse Configuration) and JWH (Prosthesis, Knee, Patellofemorotibial…). Since 2016 its 510(k)s took a median of 109 days from receipt to decision, against 144 for FDA’s reviews in the same codes and years. Its devices cite 39 predicates, 1 of them its own earlier devices. 32 recalls are linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Depuy (Ireland)’s devices, and how often a recall has named them.
FDA decisions per year
1in 2022
2026 so far, outlined.
Recalls per year
4in 2023
Class I Class II/III not classified
Planning a device like Depuy (Ireland)’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”
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