# K200068: Arthrex DynaNite K-Wire

- Pathway: 510(k) (Traditional)
- Applicant: Arthrex, Inc.
- Decided: Jun 29, 2020 after 168 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: 5 generations back to K960385 (1996). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K132895: WMT Implantable K-Wire, Wrightmedicaltechnologyinc (2013) Summary page 4.

## Indications for use
The Arthrex DynaNite K-Wire is indicated for fixation of osteotomies and reconstruction of the lesser toes following correction procedure for hammertoe.

Source page: https://510kreport.com/device/K200068
Methodology: https://510kreport.com/methodology