# K133636: Extremity Medical Hammertoe Device

- Pathway: 510(k) (Traditional)
- Applicant: Extremity Medical, LLC
- Decided: Mar 28, 2014 after 122 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 K901456 (1990). 27 ancestors in all.
31 later devices descend from it; 9 cite it directly.
0 of 59 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120645: Pro-Toe (TM) VO Hamertoe Implant System-Line Sddition, Wrightmedicaltechnologyinc (2012) Summary page 1.
- K120165: Intraosseous Fixation System, Orthohelix Surgical Designs, Inc. (2012) Summary page 1.
- K073674: Bone Fixation Wire (Kirschner Wire), Signal Medical Corp. (2008) Summary page 1.
- K061164: Activapin, Bioretec, Ltd. (2006) Summary page 1.
- K071498: Subtalar Implant, Biomet Sports Medicine, Inc. (2007) Summary page 1.
- K120449: Healix Advance Peek Anchor, Depuy Mitek (2012) Summary page 1.

## Most influential descendants
- K141857: CrossTie Intraosseous Fixation System (2015), 16 descendants of its own
- K151270: CrossTIE Intraosseous Fixation System (2015), 15 descendants of its own
- K181872: MIS Bunion System (2019), 14 descendants of its own
- K221181: Treace Medical Concepts (TMC) Plating System (2023), 7 descendants of its own
- K161449: HammerTech Fixation System (2016), 5 descendants of its own

## Indications for use
The HammerFiX device is indicated for the fixation of osteotomies and reconstruction of the lesser toes following correction procedures for hammertoe, claw toe and mallet toe.

Source page: https://510kreport.com/device/K133636
Methodology: https://510kreport.com/methodology