# K022771: Twin Fix

- Pathway: 510(k) (Traditional)
- Applicant: Fixano SA
- Decided: Sep 23, 2002 after 33 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: 3 generations back to K951357 (1995). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K891066: Danek Wrist Fixator, Danek Medical, Inc. (1989) Summary page 1.
- K012062: PF2, Fixano SA (2001) Summary page 1.

## Indications for use
The Fixano TWIN FIX wrist fixation device 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/K022771
Methodology: https://510kreport.com/methodology