FDA applicant
Smith & Nephew, Inc., Orthopaedic Div.
FDA records 10 decisions for Smith & Nephew, Inc., Orthopaedic Div. (Memphis, TN) from 1996 to 1999: 10 510(k) clearances. Most are in product codes JDW (Pin, Fixation, Threaded) and JDI (Prosthesis, Hip, Semi-Constrained…). Its devices cite 3 predicates, 0 of them its own earlier devices. No recall is linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Smith & Nephew, Inc., Orthopaedic Div.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Smith & Nephew, Inc., Orthopaedic Div. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Smith & Nephew, Inc., Orthopaedic Div.’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 “Smith”
FDA records each applicant name separately; these may or may not be the same firm.