# K213069: CoLink NeoFuse Plating System

- Pathway: 510(k) (Traditional)
- Applicant: In2bones USA, LLC
- Decided: Dec 13, 2021 after 81 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). 244 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 246 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K173121: Ankle Fusion Plating System, In2bones Sas (2017) Summary page 5.
- K163293: Colink™ Plating System, In2bones USA, LLC (2017) Summary page 5.
- K121425: Ortholoc 3DI Ankle Fusion Plating System, Wrightmedicaltechnologyinc (2012) Summary page 5.
- K181113: CoLink™ Afx Plating System, In2bones USA, LLC (2018) Summary page 5.

## Most influential descendants
- K241387: CoLink NeoFuse MIS Plating System (see attached parts list) (2024), 0 descendants of its own

## Indications for use
The CoLink@ NeoFuse Plating System is indicated for anterior fixation of ankle arthrodesis and fractures, including the distal tibia and talus. The addition of a compression screw through the tibiotalar joint (example CoLag 6.7mm screw) is required.

Source page: https://510kreport.com/device/K213069
Methodology: https://510kreport.com/methodology