# K991941: Ebi Xfix DFS Rail System

- Pathway: 510(k) (Traditional)
- Applicant: Electro-Biology, Inc.
- Decided: Aug 19, 1999 after 71 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.
9 later devices descend from it; 4 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) EBI XFIX DynaFix Fixation System: named in the summary without a submission number
- (no number) Adult Limb Reconstruction System: named in the summary without a submission number
- (no number) Heidelberg External Fixator: named in the summary without a submission number

## 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
- K202348: External Remote Controller ERC 4P (2020), 0 descendants of its own

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

Source page: https://510kreport.com/device/K991941
Methodology: https://510kreport.com/methodology