# K212996: Sterile PHALINX Hammertoe System

- Pathway: 510(k) (Traditional)
- Applicant: Wrightmedicaltechnologyinc
- Decided: Nov 16, 2021 after 57 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: 8 generations back to K013888 (2002). 22 ancestors in all.
No later device cites it as a predicate yet.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K150252: PHALINX Hammertoe System, Wrightmedicaltechnologyinc (2015) Summary page 4.

## Indications for use
The PHALINX™ Hammertoe System is indicated for the fixation of osteotomies and reconstruction of the lesser toes following correction procedures for hammertoe, claw toe, and mallet toe. Cannulated Implants in the PHALINX™ Hammertoe Fixation System can be used with k-wires for the delivery of implants or the temporary stabilization of outlying joints (e.g. MTP Joint).

Source page: https://510kreport.com/device/K212996
Methodology: https://510kreport.com/methodology