# K110047: Verticor K-Wire System

- Pathway: 510(k) (Traditional)
- Applicant: Verticor, Ltd.
- Decided: Feb 28, 2011 after 53 days
- Product code: HTY (Pin, Fixation, Smooth)
- 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: 3 generations back to K960385 (1996). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030336: Kmedic External Fixation Devices, Teleflex Medical Group (2003) Summary page 1.
- K100736: Kirschner and Guide Wires, Smt Schilling Metalltechnik GmbH (2010) Summary page 1.

## Indications for use
The Verticor K-Wire System is intended for use in fixation of bone fractures, fusion of joints or bone reconstruction, for osteotomies in the presence of adequate immobilization and as guide pins for insertion of other implants.

Source page: https://510kreport.com/device/K110047
Methodology: https://510kreport.com/methodology