# K191424: Interphalangeal Joint Fusion Device Range

- Pathway: 510(k) (Traditional)
- Applicant: Neosteo
- Decided: Aug 28, 2019 after 91 days
- Product code: HWC (Screw, Fixation, Bone)
- 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 K901456 (1990). 32 ancestors in all.
No later device cites it as a predicate yet.
0 of 33 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133636: Extremity Medical Hammertoe Device, Extremity Medical, LLC (2014) Summary page 4.
- K101165: Pro-Toe VO Hammertow Implant System, Wrightmedicaltechnologyinc (2010) Summary page 4.
- K100736: Kirschner and Guide Wires, Smt Schilling Metalltechnik GmbH (2010) Summary page 4.

## Indications for use
The Interphalangeal Joint Fusion Devices are intended for the fixation of osteotomies and reconstruction of the lesser toes following correction procedures for hammertoe, claw toe and mallet toe.

Source page: https://510kreport.com/device/K191424
Methodology: https://510kreport.com/methodology