Cleared Traditional

K140576 - Y WIRE 2 (FDA 510(k) Clearance)

Class I Orthopedic device.

K140576 · Safewire, LLC · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2014
Decision
75d
Days
Class 1
Risk

K140576 is an FDA 510(k) clearance for the Y WIRE 2. Classified as Passer, Wire, Orthopedic (product code HXI), Class I - General Controls.

Submitted by Safewire, LLC (Holland, US). The FDA issued a Cleared decision on May 20, 2014 after a review of 75 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.4540 - the FDA orthopedic device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Safewire, LLC devices

Submission Details

510(k) Number K140576 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 06, 2014
Decision Date May 20, 2014
Days to Decision 75 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
47d faster than avg
Panel avg: 122d · This submission: 75d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code HXI Passer, Wire, Orthopedic
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 888.4540
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.