FDA applicant
Trax Surgical
FDA records 3 decisions for Trax Surgical (Stoughton, MA) from 2023 to 2026: 3 510(k) clearances. Most are in product codes HWC (Screw, Fixation, Bone) and MBI (Fastener, Fixation, Nondegradable, Soft Tissue). Since 2016 its 510(k)s took a median of 164 days from receipt to decision, against 65 for FDA’s reviews in the same codes and years. Its devices cite 7 predicates, 0 of them its own earlier devices. No recall is linked to its devices.
FDA’s records also spell it “Trax Surgical, Inc.”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Trax Surgical’s devices, and how often a recall has named them.
FDA decisions per year
1in 2025
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2023.
Planning a device like Trax Surgical’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) Report