# K163293: Colink™ Plating System

- Pathway: 510(k) (Traditional)
- Applicant: In2bones USA, LLC
- Decided: May 5, 2017 after 164 days
- Product code: HRS (Plate, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K000684 (2000). 13 ancestors in all.
21 later devices descend from it; 14 cite it directly.
0 of 35 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083447: Memometal Anchorage Bone Plate System, Models PLSS/PLSL, PLP10/PLP20/PLP30/PLP40/PLP50, Memometal Technologies (2009) Summary page 4.
- K123000: Integra Total Foot Systems, Integra LifeSciences Corporation (2012) Summary page 4.

## Most influential descendants
- K172300: CoLink View Plating System (2017), 16 descendants of its own
- K181113: CoLink™ Afx Plating System (2018), 14 descendants of its own
- 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

## Recalls of this device
- Jul 16, 2018 · Class II · Z-2880-2018: CoLink(TM) Lapidus Plate +2mm Right and Left, were laser marked incorrectly. In these lots, right plates were laser marked as left plates and the left plates were laser marked as right plates.
- Jul 16, 2018 · Class II · Z-2879-2018: CoLink(TM) Lapidus Plate +2mm Right and Left, were laser marked incorrectly. In these lots, right plates were laser marked as left plates and the left plates were laser marked as right plates.

## 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.

Source page: https://510kreport.com/device/K163293
Methodology: https://510kreport.com/methodology