# K001358: Ebi Xfix DFS Metaphyseal Correction System

- Pathway: 510(k) (Special)
- Applicant: Ebi, L.P.
- Decided: May 23, 2000 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
No predicates in its family tree.
4 later devices descend from it; 2 cite it directly.
0 of 5 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

## Most influential descendants
- K081244: Lower Extremity External Fixation - Expanded Indications (2008), 2 descendants of its own
- K241769: Response Ortho Metaphyseal Hinge Fixator System (2024), 0 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® DFS® Metaphyseal Correction 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/K001358
Methodology: https://510kreport.com/methodology