# K170326: dynaMX Intramedullary Implant

- Pathway: 510(k) (Traditional)
- Applicant: Arthrex, Inc.
- Decided: Jul 20, 2017 after 168 days
- Product code: HTY (Pin, Fixation, Smooth)
- 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: 6 generations back to K013888 (2002). 22 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K960385: Sterile Kirschner Wires and Steinmann Pins, Depuy, Inc. (1996) Summary page 4.
- K120165: Intraosseous Fixation System, Orthohelix Surgical Designs, Inc. (2012) Summary page 4.
- K140148: Pro-Toe Hammertoe Fixation System, Wrightmedicaltechnologyinc (2014) Summary page 4.
- K133520: Hammerlock 2, Biomedical Enterprises, Inc. (2014) Summary page 4.
- K070598: Memometal Intra-Medullary Bone Fastener, Models Smart Toe / X-Fuse, Memometal Technologies (2007) Summary page 4.

## Most influential descendants
- K190287: Arthrex DynaNite® PIP (Hammertoe) Implant (2019), 1 descendant of its own
- K231147: Hammerdesis™ Interphalangeal Fusion System (2023), 0 descendants of its own

## Indications for use
The dynaMX™ Intramedullary Fixation Device is indicated to stabilize and aid in the fixation of fractures, fusions, and osteotomies of the phalanges.

Source page: https://510kreport.com/device/K170326
Methodology: https://510kreport.com/methodology