# K141937: Trident Fusion Implant

- Pathway: 510(k) (Traditional)
- Applicant: Vilex IN Tennessee, Inc.
- Decided: Sep 10, 2014 after 55 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: 4 generations back to K013888 (2002). 13 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111536: Metasurg Digifuse Implant, Metasurg (2011) Summary page 4.
- K120645: Pro-Toe (TM) VO Hamertoe Implant System-Line Sddition, Wrightmedicaltechnologyinc (2012) Summary page 4.
- K101165: Pro-Toe VO Hammertow Implant System, Wrightmedicaltechnologyinc (2010) Summary page 4.
- K022599: Newdeal K Wire, New Deal, S.A. (2002) Summary page 4.
- K052736: Arthrex K-Wire ,Threaded Models AR-8990 to 899X, AR-8991T to AR-899XT, Arthrex, Inc. (2005) Summary page 4.

## Most influential descendants
- K150211: EzFuze Implant System (2015), 0 descendants of its own

## Indications for use
The Trident Fusion Implant has the following Indications for Use: Fixation of osteotomies and reconstruction of the lesser toes and lesser fingers following correction procedures for hammertoe, claw toe, mallet toe, and other deformities of the feet and hands.

Source page: https://510kreport.com/device/K141937
Methodology: https://510kreport.com/methodology