# K122415: X-Fix Dynamic External Distractor

- Pathway: 510(k) (Traditional)
- Applicant: Arex USA, LLC
- Decided: Mar 15, 2013 after 219 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: 3 generations back to K970713 (1997). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K094043: Ligamentotaxor, Arex USA (2010) Summary page 1.

## Indications for use
The X-FIX is an external fixation system intended for use in the treatment of complex fracture dislocations, stable and unstable dislocations, fracture luxations. and pilon fractures in the PIP joint.

Source page: https://510kreport.com/device/K122415
Methodology: https://510kreport.com/methodology