# K212487: CoLink Vallux Plating System

- Pathway: 510(k) (Traditional)
- Applicant: In2bones USA, LLC
- Decided: Nov 18, 2021 after 101 days
- Product code: HRS (Plate, Fixation, Bone)
- 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: 17 generations back to K962616 (1996). 225 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 230 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K163293: Colink™ Plating System, In2bones USA, LLC (2017) Summary page 4.
- K181872: MIS Bunion System, Crossroads Extremity Systems, LLC (2019) Summary page 5.
- K153204: In2Bones Kirschner wire, In2bones Sas (2016) Summary page 5.
- K191535: CoLink® Mini Plating System, In2bones USA, LLC (2019) Summary page 5.
- K181113: CoLink™ Afx Plating System, In2bones USA, LLC (2018) Summary page 5.

## Most influential descendants
- K211650: The Radian MIS Bunion System (2021), 3 descendants of its own
- K253718: enHAnce PEEK Bunion System (2026), 1 descendant of its own
- K262098: EnHAnce PEEK Bunion System (2026), 0 descendants of its own
- K253423: ToeJack MIS Bunion System (2025), 0 descendants of its own

## Indications for use
The In2Bones USA, CoLink Vallux Plating System is indicated for fixation of translational osteotomies and corrective procedures of the hallux and associated disorders such as hallux valgus.

Source page: https://510kreport.com/device/K212487
Methodology: https://510kreport.com/methodology