# K181113: CoLink™ Afx Plating System

- Pathway: 510(k) (Traditional)
- Applicant: In2bones USA, LLC
- Decided: Jun 15, 2018 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: 15 generations back to K962616 (1996). 121 ancestors in all.
14 later devices descend from it; 9 cite it directly.
0 of 136 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.
- K983495: Syntec-Taichung Non-Sterile Bone Plate and Screw Implants, Model#'S 222020-248120, 240050-240980, 241130-246620, 4240420, Syntec Scientific Corp. (1998) Summary page 5.
- K151886: Acumed Ankle and Small Fragment Base Set Update, Acumed, LLC (2015) Summary page 5.
- K011335: Synths One-Third Tubular DCL Plate, Synthes (Usa) (2001) Summary page 5.

## Most influential descendants
- K191535: CoLink® Mini Plating System (2019), 6 descendants of its own
- 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
- K213069: CoLink NeoFuse Plating System (2021), 1 descendant of its own

## Indications for use
The In2Bones USA LLC, CoLink™ 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 LLC, 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.

Source page: https://510kreport.com/device/K181113
Methodology: https://510kreport.com/methodology