# K163327: Precifit Medical Kirschner Wires

- Pathway: 510(k) (Traditional)
- Applicant: Precifit Medical, Ltd.
- Decided: May 8, 2017 after 161 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: 3 generations back to K960385 (1996). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K153204: In2Bones Kirschner wire, In2bones Sas (2016) Summary page 4.

## Indications for use
Kirschner wires are indicated for fixation of bone fractures, bone reconstruction, and as guide pins for insertion of other implants. The size of Kirschner wire should be adapted to the specific indications.

Source page: https://510kreport.com/device/K163327
Methodology: https://510kreport.com/methodology