# K140576: Y WIRE 2

- Pathway: 510(k) (Traditional)
- Applicant: Safewire, LLC
- Decided: May 20, 2014 after 75 days
- Product code: HXI (Passer, Wire, Orthopedic)
- Device class: 1
- Regulation: 21 CFR 888.4540
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) K2M - K Wire: named in the summary without a submission number
- (no number) Nuvasive - K Wire: named in the summary without a submission number

## Indications for use
Y-Wire2 guidewire is intended for use by surgeons to assist with the proper introduction and placement of orthopedic instruments and implants.

Source page: https://510kreport.com/device/K140576
Methodology: https://510kreport.com/methodology