# K011711: Modification to Ebi Efix Vision Fixation System

- Pathway: 510(k) (Special)
- Applicant: Ebi, L.P.
- Decided: Jun 29, 2001 after 25 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: 1 generation back to K993886 (1999). 1 ancestor in all.
13 later devices descend from it; 4 cite it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K993886: Ebi Xfix Vision Fixation System, Ebi, L.P. (1999) Summary page 1.

## Most influential descendants
- K014194: Modification to Ebi Xfix Vision Fixation System (2002), 11 descendants of its own
- K020141: Modification to Ebi Xfix Vision Fixation System (2002), 9 descendants of its own
- K021031: Ebi Xfix Rail System (2002), 8 descendants of its own
- K033635: Modification to Ebi Xfix Vision Fixation System (2003), 4 descendants of its own
- K031875: Inter-OS Limb Lengthener (2003), 4 descendants of its own

## Indications for use
The EBI® XFIX® Vision® Fixation 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/K011711
Methodology: https://510kreport.com/methodology