# K093550: Mini Rail External Fixator System

- Pathway: 510(k) (Special)
- Applicant: Small Bone Innovations, Inc.
- Decided: Jan 7, 2010 after 51 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: 2 generations back to K861766 (1986). 3 ancestors in all.
8 later devices descend from it; 3 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K964094: Minifix, Ferguson Medical (1996) Summary page 1.

## Most influential descendants
- K132820: Vilex Ultima External Fixation System with HA Coated Pins and Wires (2014), 5 descendants of its own
- K163487: Ultima HA Coated Half Pins and Wire (2017), 4 descendants of its own
- K243798: Orthex External Fixation System (2025), 1 descendant of its own
- K202054: Dynex Ring Fixation System, Diametrix Ring Fixation System (2020), 1 descendant of its own
- K260900: DYNEX® External Fixation Systems (2026), 0 descendants of its own

## Indications for use
The SBi Mini Rail External Fixation System is indicated for use in external fixation of fractures and/or reconstruction of small bones, including metacarpal and metatarsal.

Source page: https://510kreport.com/device/K093550
Methodology: https://510kreport.com/methodology