# K953406: Ebi X Fix Dynafix System (DFS)

- Pathway: 510(k) (Traditional)
- Applicant: Electro-Biology, Inc.
- Decided: Oct 31, 1995 after 103 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
No predicates in its family tree.
21 later devices descend from it; 17 cite it directly.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K031919: Ebi Xfix DFS System (2003), 6 descendants of its own
- K021695: Ebi Dynafix Diaphyseal Correction System (2002), 5 descendants of its own
- K040935: Ebi Xfix DFS System (2004), 4 descendants of its own
- K023324: Modification to Ebi Xfix DFS System (2002), 4 descendants of its own
- K031093: Ebi Xfix Optirom Knee Fixator (2003), 3 descendants of its own

Source page: https://510kreport.com/device/K953406
Methodology: https://510kreport.com/methodology