FDA applicant
Wrightmedicaltechnologyinc
FDA records 303 decisions for Wrightmedicaltechnologyinc (Arlington, TN) from 1993 to 2023: 302 510(k) clearances and 1 original PMA approval. Most are in product codes HRS (Plate, Fixation, Bone) and HWC (Screw, Fixation, Bone). Since 2016 its 510(k)s took a median of 131 days from receipt to decision, against 111 for FDA’s reviews in the same codes and years. Its devices cite 334 predicates, 255 of them its own earlier devices. 115 recalls are linked to its devices, 14 Class I.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Wrightmedicaltechnologyinc’s devices, and how often a recall has named them.
FDA decisions per year
1in 2023
2026 so far, outlined.
Recalls per year
1in 2026
Class I Class II/III not classified
Planning a device like Wrightmedicaltechnologyinc’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
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