# K040833: Modification to Ebi Xfix Vision Fixation System

- Pathway: 510(k) (Special)
- Applicant: Ebi, L.P.
- Decided: Apr 29, 2004 after 29 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: 4 generations back to K993886 (1999). 4 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 8 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 2.
- K014194: Modification to Ebi Xfix Vision Fixation System, Ebi, L.P. (2002) Summary page 1.
- K033635: Modification to Ebi Xfix Vision Fixation System, Ebi, L.P. (2003) Summary page 2.

## Cited in the summary but kept off the family tree
- K001711: M2410B Imagepoint HX Multispecialty System, Version B.1, Agilent Technologies, Inc. (2000). Our reading of the summary gave K001711, FDA’s number for M2410B Imagepoint HX Multispecialty System, Version B.1 (Agilent Technologies, Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “EBI® XFIX® Vision® Fixation System”. Kept off the family tree.

## Most influential descendants
- K081244: Lower Extremity External Fixation - Expanded Indications (2008), 2 descendants of its own
- K122210: Newfix External Fixation System (2013), 0 descendants of its own
- K102843: Mac Male Adapter (2011), 0 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/K040833
Methodology: https://510kreport.com/methodology