# K241387: CoLink NeoFuse MIS Plating System (see attached parts list)

- Pathway: 510(k) (Traditional)
- Applicant: In2bones USA
- Decided: Aug 13, 2024 after 90 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). 245 ancestors in all.
No later device cites it as a predicate yet.
0 of 246 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K213069: CoLink NeoFuse Plating System, In2bones USA, LLC (2021) Summary page 5.
- K173121: Ankle Fusion Plating System, In2bones Sas (2017) Summary page 5.

## Indications for use
The CoLink® NeoFuse MIS Plating System is a fusion plate indicated for anterior fixation of ankle arthrodesis and fractures, including the distal tibia and talus. The addition of a posterior compression screw and a fully threaded screw through the tibiotalar joint (example CoLag 6.7mm screw) are required for ankle fusion procedure.

Source page: https://510kreport.com/device/K241387
Methodology: https://510kreport.com/methodology