FDA applicant
DePuy Orthopaedics, Inc.
FDA records 213 decisions for DePuy Orthopaedics, Inc. (Warsaw, IN) from 1998 to 2026: 210 510(k) clearances and 3 original PMA approvals. Most are in product codes LPH (Prosthesis, Hip, Semi-Constrained…) and HRS (Plate, Fixation, Bone). Since 2016 its 510(k)s took a median of 57 days from receipt to decision, against 138 for FDA’s reviews in the same codes and years. Its devices cite 497 predicates, 216 of them its own earlier devices. 633 recalls are linked to its devices, 4 Class I.
FDA’s records also spell it “Depuy Orthopaedics”, “Depuy Orthopaedics, Inc.”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided DePuy Orthopaedics, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2023
2026 so far, outlined.
Recalls per year
1in 2023
Class I Class II/III not classified
Planning a device like DePuy Orthopaedics, 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 “DePuy”
FDA records each applicant name separately; these may or may not be the same firm.