# K070393: Lagwire System

- Pathway: 510(k) (Traditional)
- Applicant: Fxdevices
- Decided: May 4, 2007 after 84 days
- Product code: HWC (Screw, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3040
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K013903 (2001). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042244: Bone-Lok MVP Cortical-Cancellous Compression Device, Triage Medical, Inc. (2004) Summary page 1.

## Indications for use
The Lagwire is indicated for use in the general management of fractures and reconstructive surgery.

Source page: https://510kreport.com/device/K070393
Methodology: https://510kreport.com/methodology