# K140148: Pro-Toe Hammertoe Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Wrightmedicaltechnologyinc
- Decided: Mar 7, 2014 after 44 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: 5 generations back to K013888 (2002). 15 ancestors in all.
20 later devices descend from it; 6 cite it directly.
0 of 36 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)
- K120645: Pro-Toe (TM) VO Hamertoe Implant System-Line Sddition, Wrightmedicaltechnologyinc (2012) Summary page 1.
- K122959: Hammer Toe Implant, Trilliant Surgical, Ltd. (2012) Summary page 1.
- K132895: WMT Implantable K-Wire, Wrightmedicaltechnologyinc (2013) Summary page 1.

## Most influential descendants
- K142585: PhaLinx Hammertoe System (2014), 9 descendants of its own
- K150252: PHALINX Hammertoe System (2015), 6 descendants of its own
- K151838: PRO-TOE Hammertoe Fixation System (2015), 4 descendants of its own
- K200840: DuoHex CH Cannulated Hammertoe System (2020), 3 descendants of its own
- K190926: Hammertoe Truss System (HTS) (2019), 3 descendants of its own

## Indications for use
The PRO-TOE® Hammertoe Fixation Systems are 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 PRO-TOE® Hammertoe Fixation Systems can be used with K-wires for the delivery of implants or the temporary stabilization of outlying joints (e.g. MTP Joint). The Implantable K-Wires are indicated for use in fixation of bone fractures, for bone reconstructions, and as guide pins for insertion of other implants. Additionally, Implantable K-Wires are indicated for the fixation of osteotomies and reconstruction of the lesser toe following correction procedures for hammertoe, claw toe, mallet toe, and metatarsophalangeal joint instability.

Source page: https://510kreport.com/device/K140148
Methodology: https://510kreport.com/methodology