FDA applicant
Synthes
FDA records 26 decisions for Synthes (West Chester, PA) from 1998 to 2026: 26 510(k) clearances. Most are in product codes HRS (Plate, Fixation, Bone) and JEY (Plate, Bone). Since 2016 its 510(k)s took a median of 146 days from receipt to decision, against 96 for FDA’s reviews in the same codes and years. Its devices cite 65 predicates, 2 of them its own earlier devices. 19 recalls are linked to its devices.
FDA’s records also spell it “Synthes, Inc.”, “Synthes GmbH”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Synthes’s devices, and how often a recall has named them.
FDA decisions per year
2in 2025
2026 so far, outlined.
Recalls per year
6in 2015
Class I Class II/III not classified
Planning a device like 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 “Synthes”
FDA records each applicant name separately; these may or may not be the same firm.