# K993649: Ebi Xfix DFS Wristfix System

- Pathway: 510(k) (Special)
- Applicant: Ebi, L.P.
- Decided: Nov 19, 1999 after 21 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: 1 generation back to K951357 (1995). 2 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K951357: Ebi Small External Fixator (S/E/F/), Electro-Biology, Inc. (1995) Summary page 1.
- K963618: Synthes Simple Small External Fixator (Ssef), Synthes (Usa) (1996) Summary page 1.

## Most influential descendants
- K012062: PF2 (2001), 1 descendant of its own
- K022771: Twin Fix (2002), 0 descendants of its own
- K020311: Clearview Wrist Fixator (2002), 0 descendants of its own

## Indications for use
The EBI XFIX DFS Wristfix System is intended for use in upper extremity applications for the reduction, alignment and stabilization of intra-articular and extra-articular fractures, corrective osteotomies, and soft tissue deformities.

Source page: https://510kreport.com/device/K993649
Methodology: https://510kreport.com/methodology