Trax EX Anchor— 510(k) K251750

Name: FDA 510(k) clearance K251750
Creator: U.S. Food and Drug Administration
Published: 2026-03-12

Substantially Equivalent

Trax Surgical, Inc.

FDA 510(k) clearance K251750 for Trax EX Anchor, Substantially Equivalent on 2026-03-12. Applicant: Trax Surgical, Inc.. Device class: 2.

Summary

Trax Surgical's Trax EX Anchor is filed under MBI, nondegradable soft tissue fixation fasteners. The record doesn't list anchor sizes.

Class II, 21 CFR 888.3040. It was a Traditional 510(k), and Orthopedic is both the classification panel and the review panel.

Trax Surgical filed from Stoughton, Massachusetts. The decision came 276 calendar days after FDA received it (June 9, 2025 to March 12, 2026).

Clearance details

Applicant: Trax Surgical, Inc.
Product code: Product code MBI
Device class: Class 2
Regulation: 21 CFR 888.3040
Advisory panel: Orthopedic
Date received: 2025-06-09
Decision date: 2026-03-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Stoughton, MA, US

Download summary PDF View on FDA.gov ↗

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K263352 — TeKBrace Knotless Anchor2026-10-21
K261869 — Integrity Retractable Implant Inserter (6000127)2026-09-17
K253065 — Aevumed SUPERCYNCH Button System2026-09-02

Adverse events under product code MBI

product code MBI

Injury: 3,163
Malfunction: 13,006
Other: 2
Total: 16,171

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.