# K000319: Ebi Xfix DFS System

- Pathway: 510(k) (Special)
- Applicant: Ebi, L.P.
- Decided: Feb 25, 2000 after 23 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.
700 later devices descend from it; 3 cite it directly.
0 of 701 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K020279: Forex Corporation, Optima, Spinal System (2002), 693 descendants of its own
- K031585: U&I, Optima, Spinal System (2003), 579 descendants of its own
- K024096: Optima, Spinal System (2003), 466 descendants of its own
- K053573: GSS Pedicle Screw System (2006), 181 descendants of its own
- K033090: Icon Polyaxial Pedicle Screw System (2004), 180 descendants of its own

Source page: https://510kreport.com/device/K000319
Methodology: https://510kreport.com/methodology