# K951357: Ebi Small External Fixator (S/E/F/)

- Pathway: 510(k) (Traditional)
- Applicant: Electro-Biology, Inc.
- Decided: Jun 21, 1995 after 89 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.
21 later devices descend from it; 5 cite it directly.
0 of 22 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
- K052005: R&R External Fixation System (2005), 11 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
- K162033: SALVATION External Fixation System (2017), 3 descendants of its own
- K993649: Ebi Xfix DFS Wristfix System (1999), 3 descendants of its own

Source page: https://510kreport.com/device/K951357
Methodology: https://510kreport.com/methodology