# K160194: StarFuse Interphalangeal Pin

- Pathway: 510(k) (Traditional)
- Applicant: Phalanx Innovations
- Decided: Apr 26, 2016 after 90 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: 6 generations back to K983121 (1998). 14 ancestors in all.
No later device cites it as a predicate yet.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112675: Arrow-Lok Digital System, Arrowhead Medical Device Technologies, LLC (2011) Summary page 4.

## Indications for use
The StarFuse Interphalangeal Pin is indicated for use with osteotomies, arthrodeses, and reconstruction procedures involving the correction of the lesser digits of the toes.

Source page: https://510kreport.com/device/K160194
Methodology: https://510kreport.com/methodology