FDA applicant
Synthes (Usa)
FDA records 419 decisions for Synthes (Usa) (Paoli, PA) from 1977 to 2018: 418 510(k) clearances and 1 original PMA approval. Most are in product codes HRS (Plate, Fixation, Bone) and JEY (Plate, Bone). Its devices cite 217 predicates, 134 of them its own earlier devices. 206 recalls are linked to its devices, 3 Class I.
FDA’s records also spell it “Synthes USA”, “Synthes (Usa), LLC”, “Synthes USA, LLC”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Synthes (Usa)’s devices, and how often a recall has named them.
FDA decisions per year
1in 2018
2026 so far, outlined.
Recalls per year
2in 2024
Class I Class II/III not classified
Planning a device like Synthes (Usa)’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.