# K012078: Radiofix

- Pathway: 510(k) (Traditional)
- Applicant: Fixano SA
- Decided: Sep 27, 2001 after 87 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 K960014 (1996). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K983881: Cobra External Fixator, Orthopaedic Innovations, Inc. (1998) Summary page 1.
- (no number) Orthofix Non-bridging Pennig Wrist Fixator: named in the summary without a submission number

## Indications for use
The Fixano Radiofix wrist fixation device is intended for use in the fixation of unstable or comminuted extra-articular epiphyseal fracture of the distal radius, by compression, flexion or extension. The epiphyseal fragment must be in one single piece.

Source page: https://510kreport.com/device/K012078
Methodology: https://510kreport.com/methodology