# K142585: PhaLinx Hammertoe System

- Pathway: 510(k) (Traditional)
- Applicant: Wrightmedicaltechnologyinc
- Decided: Nov 20, 2014 after 66 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: 6 generations back to K013888 (2002). 20 ancestors in all.
9 later devices descend from it; 3 cite it directly.
0 of 30 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K113006: I-Fuse Hammer Toe Systems, Orthopro, LLC (2012) Summary page 4.
- K022599: Newdeal K Wire, New Deal, S.A. (2002) Summary page 4.
- K132895: WMT Implantable K-Wire, Wrightmedicaltechnologyinc (2013) Summary page 4.
- K140148: Pro-Toe Hammertoe Fixation System, Wrightmedicaltechnologyinc (2014) Summary page 4.

## Most influential descendants
- K150252: PHALINX Hammertoe System (2015), 6 descendants of its own
- K200840: DuoHex CH Cannulated Hammertoe System (2020), 3 descendants of its own
- K213530: Nextra CH Cannulated Hammertoe System (2021), 1 descendant of its own
- K221610: Nextra CH Cannulated Hammertoe System (2022), 0 descendants of its own
- K212996: Sterile PHALINX Hammertoe System (2021), 0 descendants of its own

## Indications for use
The PhaLinx® Hammertoe System is designed for small bone fusion and fractures. It is indicated for fractures, and inter-digital fusion of the fingers, toes and small bones.

Source page: https://510kreport.com/device/K142585
Methodology: https://510kreport.com/methodology