# K161449: HammerTech Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Fusion Orthopedics, LLC
- Decided: Oct 11, 2016 after 139 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 K901456 (1990). 30 ancestors in all.
5 later devices descend from it; 2 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)
- K133636: Extremity Medical Hammertoe Device, Extremity Medical, LLC (2014) Summary page 4.
- K121008: Trilliant Surgical K-Wires, Trilliant Surgical, Ltd. (2012) Summary page 4.

## Most influential descendants
- K201850: Vector Hammertoe Correction System (2020), 3 descendants of its own
- K213421: Vector® Hammertoe Correction System (2021), 2 descendants of its own
- K231453: SnapHammer Hammertoe Correction System (2024), 1 descendant of its own
- K250613: SnapHammer Hammertoe Correction System (2025), 0 descendants of its own
- K182684: HammerTechTM Fixation System (2018), 0 descendants of its own

## Indications for use
The HammerTech® 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/K161449
Methodology: https://510kreport.com/methodology