Cleared Traditional

Trax EX Anchor

K251750 · Trax Surgical, Inc. · Orthopedic
Mar 2026
Decision
276d
Days
Class 2
Risk

About This 510(k) Submission

K251750 is an FDA 510(k) clearance for the Trax EX Anchor, a Fastener, Fixation, Nondegradable, Soft Tissue (Class II — Special Controls, product code MBI), submitted by Trax Surgical, Inc. (Stoughton, US). The FDA issued a Cleared decision on March 12, 2026, 276 days after receiving the submission on June 9, 2025. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number K251750 FDA.gov
FDA Decision Cleared SESE
Date Received June 09, 2025
Decision Date March 12, 2026
Days to Decision 276 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code MBI — Fastener, Fixation, Nondegradable, Soft Tissue
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3040