FDA applicant
Depuy Mitek
FDA records 15 decisions for Depuy Mitek (Raynham, MA) from 2004 to 2026: 15 510(k) clearances. Most are in product codes JDR (Staple, Fixation, Bone) and NEW (Suture, Surgical, Absorbable, Polydioxanone). Since 2016 its 510(k)s took a median of 90 days from receipt to decision, against 54 for FDA’s reviews in the same codes and years. Its devices cite 31 predicates, 3 of them its own earlier devices. 8 recalls are linked to its devices.
FDA’s records also spell it “DePuy Mitek, Inc.”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Depuy Mitek’s devices, and how often a recall has named them.
FDA decisions per year
1in 2025
2026 so far, outlined.
Recalls per year
1in 2015
Class I Class II/III not classified
Planning a device like Depuy Mitek’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.