# K023314: Microfix

- Pathway: 510(k) (Traditional)
- Applicant: Fixano SA
- Decided: Oct 18, 2002 after 45 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.
No later device cites it as a predicate yet.
0 of 4 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.

## Indications for use
The Fixano MICROFIX device is intended for use in the external fixation of fractures and/or reconstruction of small bones, including, but not limited to, metacarpal and metatarsal.

Source page: https://510kreport.com/device/K023314
Methodology: https://510kreport.com/methodology