# K970290: Ebi X Fix Dynafix Mini External Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Ebi, L.P.
- Decided: Apr 1, 1997 after 67 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.
28 later devices descend from it; 5 cite it directly.
0 of 29 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) Orthofix® Mini Fixator: named in the summary without a submission number
- (no number) Orthofix® Mini Lengthener: named in the summary without a submission number
- (no number) Synthes Mini External Fixator: named in the summary without a submission number
- (no number) Hoffman Mini External Fixator: named in the summary without a submission number

## Most influential descendants
- K052196: Vilex X-Fix (2005), 13 descendants of its own
- K052005: R&R External Fixation System (2005), 11 descendants of its own
- K151881: X-Fix Line Additions (2016), 7 descendants of its own
- K100137: Sidekick Circular Fixator System: Struts and Hinges (2010), 6 descendants of its own
- K153635: SALVATION (R) External Fixation System (2016), 4 descendants of its own

## Indications for use
The EBI X FIX™ DynaFix® Mini External 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/K970290
Methodology: https://510kreport.com/methodology