# K182684: HammerTechTM Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Fusion Orthopedics, LLC
- Decided: Nov 23, 2018 after 58 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: 8 generations back to K013888 (2002). 48 ancestors in all.
No later device cites it as a predicate yet.
0 of 49 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K161449: HammerTech Fixation System, Fusion Orthopedics, LLC (2016) Summary page 4.
- K150252: PHALINX Hammertoe System, Wrightmedicaltechnologyinc (2015) Summary page 4.
- K121008: Trilliant Surgical K-Wires, Trilliant Surgical, Ltd. (2012) Summary page 4.

## 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/K182684
Methodology: https://510kreport.com/methodology