FDA applicant
Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.
FDA records 5 decisions for Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc. (West Chester, PA) from 2017 to 2019: 5 510(k) clearances. Most are in product codes HRS (Plate, Fixation, Bone) and KCT (Sterilization Wrap Containers, Trays…). Since 2016 its 510(k)s took a median of 269 days from receipt to decision, against 116 for FDA’s reviews in the same codes and years. Its devices cite 101 predicates, 0 of them its own earlier devices. No recall is linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
2in 2019
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2017.
Planning a device like Synthes (Usa) Products, LLC / Depuy…’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 “Synthes”
FDA records each applicant name separately; these may or may not be the same firm.