# K203698: CoLink Sfx Implant System

- Pathway: 510(k) (Traditional)
- Applicant: In2bones USA, LLC
- Decided: May 4, 2021 after 137 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: 5 generations back to K960385 (1996). 10 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 12 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 5.
- K022599: Newdeal K Wire, New Deal, S.A. (2002) Summary page 5.
- K022597: K-FIX, New Deal, S.A. (2002) Summary page 5.
- K132895: WMT Implantable K-Wire, Wrightmedicaltechnologyinc (2013) Summary page 5.

## Most influential descendants
- K231905: Electro-Spec Steri-Caps (2023), 0 descendants of its own

## Indications for use
The In2Bones USA CoLink® Sfx Implant System is a system of implantable K-wires and caps indicated for temporary fixation and stabilization of bone fractures and reconstructions. In addition, the K-wires can be used as guide pins for insertion of other implants. The caps are indicated for use in the protection of protruding ends of wires.

Source page: https://510kreport.com/device/K203698
Methodology: https://510kreport.com/methodology