FDA applicant
Synthes (USA) Products, LLC
FDA records 61 decisions for Synthes (USA) Products, LLC (West Chester, PA) from 2010 to 2026: 61 510(k) clearances. Most are in product codes HRS (Plate, Fixation, Bone) and HSB (Rod, Fixation, Intramedullary And Accessories). Since 2016 its 510(k)s took a median of 106 days from receipt to decision, against 107 for FDA’s reviews in the same codes and years. Its devices cite 218 predicates, 18 of them its own earlier devices. 39 recalls are linked to its devices, 1 Class I.
FDA’s records also spell it “Synthes USA Products, LLC”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Synthes (USA) Products, LLC’s devices, and how often a recall has named them.
FDA decisions per year
1in 2022
2026 so far, outlined.
Recalls per year
2in 2025
Class I Class II/III not classified
Planning a device like Synthes (USA) Products, LLC’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.