FDA applicant
Medacta International S.A.
FDA records 208 decisions for Medacta International S.A. (Castel San Pietro (Ch), CH) from 2008 to 2026: 208 510(k) clearances. Most are in product codes LZO (Prosthesis, Hip, Semi-Constrained…) and JWH (Prosthesis, Knee, Patellofemorotibial…). Since 2016 its 510(k)s took a median of 96 days from receipt to decision, against 111 for FDA’s reviews in the same codes and years. Its devices cite 713 predicates, 405 of them its own earlier devices. 19 recalls are linked to its devices.
FDA’s records also spell it “Medacta International”, “Medacta International, SA”, “Medacta International SA”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Medacta International S.A.’s devices, and how often a recall has named them.
FDA decisions per year
15in 2025
2026 so far, outlined.
Recalls per year
1in 2026
Class I Class II/III not classified
Planning a device like Medacta International S.A.’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 “Medacta”
FDA records each applicant name separately; these may or may not be the same firm.