# K201149: CoLink Plating System

- Pathway: 510(k) (Traditional)
- Applicant: In2bones USA, LLC
- Decided: Jul 15, 2020 after 77 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). 275 ancestors in all.
No later device cites it as a predicate yet.
0 of 276 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.
- K172300: CoLink View Plating System, In2bones USA, LLC (2017) Summary page 5.
- K181113: CoLink™ Afx Plating System, In2bones USA, LLC (2018) Summary page 5.
- K170518: In2Bones Fracture and Correction System, In2bones USA, LLC (2017) Summary page 5.
- K200762: CoLink Cfx Plating System, In2bones USA, LLC (2020) Summary page 5.

## Indications for use
The In2Bones USA, 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. The In2Bones USA, CoLink® Afx Plating System is indicated for stabilization and fixation of fractures and osteotomies in the ankle, including tibia and fibula, in both pediatric and adult patients. The In2Bones USA CoLink® Afx Plating System screws are intended to be used as stand-alone bone screws, or in a plate-screw system for fracture fixation.

Source page: https://510kreport.com/device/K201149
Methodology: https://510kreport.com/methodology