# K231147: Hammerdesis™ Interphalangeal Fusion System

- Pathway: 510(k) (Traditional)
- Applicant: Intelivation
- Decided: Sep 14, 2023 after 146 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: 19 generations back to K841189 (1984). 319 ancestors in all.
No later device cites it as a predicate yet.
0 of 320 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K190287: Arthrex DynaNite® PIP (Hammertoe) Implant, Arthrex, Inc. (2019) Summary page 5.
- K131459: Aap K-Wire, Steinmann Pin, Cerclage Wire, Aap Implantate AG (2013) Summary page 5.
- K191243: HEDRON Cervical Spacers, Globus Medical, Inc. (2019) Summary page 5.
- K192417: ARIX Cannulated Screw System, Jeil Medical Corporation (2019) Summary page 5.

## Indications for use
The Hammerdesis™ Interphalangeal Fusion System is intended to stabilize and aid in the fixation of fractures, fusions, and osteotomies of the phalanges.

Source page: https://510kreport.com/device/K231147
Methodology: https://510kreport.com/methodology