# K153204: In2Bones Kirschner wire

- Pathway: 510(k) (Traditional)
- Applicant: In2bones Sas
- Decided: Feb 1, 2016 after 89 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: 2 generations back to K960385 (1996). 3 ancestors in all.
20 later devices descend from it; 6 cite it directly.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022599: Newdeal K Wire, New Deal, S.A. (2002) Summary page 5.
- 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 5.

## Most influential descendants
- K181872: MIS Bunion System (2019), 14 descendants of its own
- K221181: Treace Medical Concepts (TMC) Plating System (2023), 7 descendants of its own
- K240173: Treace Medical Systems (TMC) Plating System (2024), 4 descendants of its own
- K212487: CoLink Vallux Plating System (2021), 4 descendants of its own
- K242415: TMC Compression Implant System (2024), 3 descendants of its own

## Indications for use
The In2Bones® Kirschner wires are indicated for fixation of bone fractures, bone reconstruction, and as guide pins for insertion of other implants. The size of the In2Bones® Kirschner wire chosen should be adapted to the specific indication.

Source page: https://510kreport.com/device/K153204
Methodology: https://510kreport.com/methodology