# K012062: PF2

- 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 K951357 (1995). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K993649: Ebi Xfix DFS Wristfix System, Ebi, L.P. (1999) Summary page 1.

## Most influential descendants
- K022771: Twin Fix (2002), 0 descendants of its own

## Indications for use
The Fixano PF2 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/K012062
Methodology: https://510kreport.com/methodology