# K012161: Flex-Nails

- Pathway: 510(k) (Traditional)
- Applicant: Fixano SA
- Decided: Aug 24, 2001 after 44 days
- Product code: HTY (Pin, Fixation, Smooth)
- Device class: 2
- Regulation: 21 CFR 888.3040
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K960385 (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)
- K960385: Sterile Kirschner Wires and Steinmann Pins, Depuy, Inc. (1996) Summary page 1.
- K983121: Non-Sterile Kirschner Wires and Steinmann Pins, Models #'S 290-101/160, 290-201/216, 290-060/330, 290-161/220, Syntec Scientific Corp. (1998) Summary page 1.
- (no number) DePuy Nancy Nail preamendment device: named in the summary without a submission number

## Indications for use
Fixano FLEX-NAILS are indicated for use in fixation of bone fractures, for bone reconstructions, as guide pins for insertion of other implants, or implantation through the skin so that traction may be applied to the skeletal system.

Source page: https://510kreport.com/device/K012161
Methodology: https://510kreport.com/methodology