# K010437: Modification to Ebi Xfix DFS Rail System

- Pathway: 510(k) (Special)
- Applicant: Ebi, L.P.
- Decided: Mar 13, 2001 after 28 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.
11 later devices descend from it; 5 cite it directly.
0 of 12 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
- K021031: Ebi Xfix Rail System (2002), 8 descendants of its own
- K031875: Inter-OS Limb Lengthener (2003), 4 descendants of its own
- K192181: PRECICE Plating System (2019), 2 descendants of its own
- K081244: Lower Extremity External Fixation - Expanded Indications (2008), 2 descendants of its own
- K012645: Reprocessed Ebi External Fixation Devices (2002), 1 descendant of its own

Source page: https://510kreport.com/device/K010437
Methodology: https://510kreport.com/methodology