# K142490: ProxiFuse Hammer Toe Device

- Pathway: 510(k) (Traditional)
- Applicant: Cartiva, Inc.
- Decided: Dec 15, 2014 after 102 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: 3 generations back to K960385 (1996). 5 ancestors in all.
2 later devices descend 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)
- K101165: Pro-Toe VO Hammertow Implant System, Wrightmedicaltechnologyinc (2010) Summary page 4.
- K022599: Newdeal K Wire, New Deal, S.A. (2002) Summary page 4.
- K050259: Arthrex Bio-Pin, Arthrex, Inc. (2005) Summary page 4.

## Most influential descendants
- K142478: opti-Toe (2015), 1 descendant of its own
- K162685: 2-Piece Hammertoe Correction System (2017), 0 descendants of its own

## Indications for use
The ProxiFuse Hammer Toe Device is indicated for the fixation of osteotomies and reconstruction of the lesser toes following correction procedures for hammertoe, claw toe, and mallet toe. Patients should be protected weight-bearing or heel-bearing until fusion or healing has occurred.

Source page: https://510kreport.com/device/K142490
Methodology: https://510kreport.com/methodology