FDA applicant
Wright Medical Corp.
FDA records 6 decisions for Wright Medical Corp. (Memphis, TN) from 1989 to 2021: 6 510(k) clearances. Most are in product codes DPW (Flowmeter, Blood, Cardiovascular) and HWC (Screw, Fixation, Bone). Since 2016 its 510(k)s took a median of 190 days from receipt to decision, against 84 for FDA’s reviews in the same codes and years. Its devices cite 5 predicates, 0 of them its own earlier devices. 1 recall is linked to its devices.
FDA’s records also spell it “Wright Medical”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Wright Medical Corp.’s devices, and how often a recall has named them.
FDA decisions per year
2in 2021
2026 so far, outlined.
Recalls per year
1in 2022
Class I Class II/III not classified
Planning a device like Wright Medical Corp.’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 “Wright”
FDA records each applicant name separately; these may or may not be the same firm.