FDA applicant
Treace Medical Concepts, Inc.
FDA records 21 decisions for Treace Medical Concepts, Inc. (Ponte Vedra, FL) from 2015 to 2026: 21 510(k) clearances. Most are in product codes HRS (Plate, Fixation, Bone) and HWC (Screw, Fixation, Bone). Since 2016 its 510(k)s took a median of 30 days from receipt to decision, against 93 for FDA’s reviews in the same codes and years. Its devices cite 46 predicates, 24 of them its own earlier devices. 1 recall is linked to its devices.
FDA’s records also spell it “Treace Medical Concepts”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Treace Medical Concepts, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2025
2026 so far, outlined.
Recalls per year
1in 2024
Class I Class II/III not classified
Planning a device like Treace Medical Concepts, Inc.’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 “Treace”
FDA records each applicant name separately; these may or may not be the same firm.