# K021031: Ebi Xfix Rail System

- Pathway: 510(k) (Traditional)
- Applicant: Ebi, L.P.
- Decided: May 16, 2002 after 48 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: 3 generations back to K993886 (1999). 7 ancestors in all.
8 later devices descend from it; 3 cite it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K991941: Ebi Xfix DFS Rail System, Electro-Biology, Inc. (1999) Summary page 1.
- K000083: Ebi Xfix DFS Rail System, Ebi, L.P. (2000) Summary page 1.
- K010437: Modification to Ebi Xfix DFS Rail System, Ebi, L.P. (2001) Summary page 1.
- K993886: Ebi Xfix Vision Fixation System, Ebi, L.P. (1999) Summary page 1.
- K014194: Modification to Ebi Xfix Vision Fixation System, Ebi, L.P. (2002) Summary page 1.
- K020141: Modification to Ebi Xfix Vision Fixation System, Ebi, L.P. (2002) Summary page 1.

## Most influential descendants
- 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
- K193617: Precice® Screws (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/K021031
Methodology: https://510kreport.com/methodology