# K202777: VeriFixx™ Small Bone Implant

- Pathway: 510(k) (Traditional)
- Applicant: Armis Biopharma, Inc.
- Decided: Nov 17, 2020 after 56 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 K901456 (1990). 34 ancestors in all.
No later device cites it as a predicate yet.
0 of 35 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.
- K171715: HammerTube System, Paragon 28 (2018) Summary page 4.

## Indications for use
The VeriFixx™ Small Bone Implant is indicated 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/K202777
Methodology: https://510kreport.com/methodology