FDA applicant
Depuy Mitek, A Johnson & Johnson Company
FDA records 59 decisions for Depuy Mitek, A Johnson & Johnson Company (Raynham, MA) from 2004 to 2015: 59 510(k) clearances. Most are in product codes MAI (Fastener, Fixation, Biodegradable, Soft Tissue) and HWC (Screw, Fixation, Bone). Its devices cite 176 predicates, 70 of them its own earlier devices. 46 recalls are linked to its devices.
FDA’s records also spell it “Depuy Mitek, A Johnson & Johnson Co.”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Depuy Mitek, A Johnson & Johnson Company’s devices, and how often a recall has named them.
FDA decisions per year
1in 2015
2026 so far, outlined.
Recalls per year
5in 2023
Class I Class II/III not classified
Planning a device like Depuy Mitek, A Johnson & Johnson Company’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 “Depuy”
FDA records each applicant name separately; these may or may not be the same firm.