# K040935: Ebi Xfix DFS System

- Pathway: 510(k) (Traditional)
- Applicant: Ebi, L.P.
- Decided: Jul 6, 2004 after 88 days
- Product code: KTT (Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K953406 (1995). 2 ancestors in all.
4 later devices descend from it; 3 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K953406: Ebi X Fix Dynafix System (DFS), Electro-Biology, Inc. (1995) Summary page 1.
- K031919: Ebi Xfix DFS System, Ebi, L.P. (2003) Summary page 1.

## Most influential descendants
- K081244: Lower Extremity External Fixation - Expanded Indications (2008), 2 descendants of its own
- K122210: Newfix External Fixation System (2013), 0 descendants of its own
- K111376: Construx External Fixation Device (2011), 0 descendants of its own
- K102843: Mac Male Adapter (2011), 0 descendants of its own

## Indications for use
The EBI® XFIX® DFS® System is a unilateral external fixation device intended for use in the treatment of bone conditions including leg lengthening, osteotomies, arthrodesis, fracture fixation, and other bone conditions amenable to treatment by use of the external fixation modality.

Source page: https://510kreport.com/device/K040935
Methodology: https://510kreport.com/methodology