# K201715: Smart Toe II, X Fuse

- Pathway: 510(k) (Traditional)
- Applicant: Stryker GmbH
- Decided: Aug 5, 2020 after 43 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: 4 generations back to K960385 (1996). 6 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112197: Memometal Intra-Medullary Bone Fastener, Memometal Technologies (2011) Summary page 5.

## Most influential descendants
- K253325: ZipToe™ Hammertoe Fusion System (2025), 0 descendants of its own

## Indications for use
The Smart Toe II is indicated for interphalangeal fusion of the toes. The X Fuse is indicated for interphalangeal fusion of fingers and toes.

Source page: https://510kreport.com/device/K201715
Methodology: https://510kreport.com/methodology