# K191535: CoLink® Mini Plating System

- Pathway: 510(k) (Traditional)
- Applicant: In2bones USA, LLC
- Decided: Jul 29, 2019 after 49 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: 16 generations back to K962616 (1996). 193 ancestors in all.
6 later devices descend from it; 2 cite it directly.
0 of 200 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 5.
- K170518: In2Bones Fracture and Correction System, In2bones USA, LLC (2017) Summary page 5.
- K181113: CoLink™ Afx Plating System, In2bones USA, LLC (2018) Summary page 5.

## Most influential descendants
- K212487: CoLink Vallux Plating System (2021), 4 descendants of its own
- 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 LLC, CoLink® Plating System/CoLink® View Plating System/CoLink® Mini Plating System is indicated for stabilization and fixation of fractures, revision procedures, joint fusion, osteotomies and reconstruction of the small bones in the hand, wrist, foot and ankle in both pediatric and adult patients.

Source page: https://510kreport.com/device/K191535
Methodology: https://510kreport.com/methodology