# K993886: Ebi Xfix Vision Fixation System

- Pathway: 510(k) (Special)
- Applicant: Ebi, L.P.
- Decided: Dec 14, 1999 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.
14 later devices descend from it; 7 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)
- None. The FDA summary names its predicate without a number.
- (no number) EBI XFIX® DFS® System: named in the summary without a submission number
- (no number) Hoffmann II External Fixation System: named in the summary without a submission number

## Most influential descendants
- K011711: Modification to Ebi Efix Vision Fixation System (2001), 13 descendants of its own
- 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

## 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/K993886
Methodology: https://510kreport.com/methodology