# K190287: Arthrex DynaNite® PIP (Hammertoe) Implant

- Pathway: 510(k) (Traditional)
- Applicant: Arthrex, Inc.
- Decided: May 3, 2019 after 81 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: 7 generations back to K013888 (2002). 23 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K170326: dynaMX Intramedullary Implant, Arthrex, Inc. (2017) Summary page 4.

## Most influential descendants
- K231147: Hammerdesis™ Interphalangeal Fusion System (2023), 0 descendants of its own

## Indications for use
The Arthrex DynaNite® PIP (Hammertoe) Implant is intended to stabilize and aid in the fixation of fractures, fusions, and osteotomies of the phalanges.

Source page: https://510kreport.com/device/K190287
Methodology: https://510kreport.com/methodology