# K213698: CoLink PCR Plating System

- Pathway: 510(k) (Traditional)
- Applicant: In2bones USA, LLC
- Decided: May 27, 2022 after 185 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 K841189 (1984). 178 ancestors in all.
No later device cites it as a predicate yet.
0 of 179 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.
- K170401: Piccolo Composite® Plate System, CarboFix Orthopedics, Ltd. (2017) Summary page 5.

## Indications for use
The CoLink@ PCR 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.

Source page: https://510kreport.com/device/K213698
Methodology: https://510kreport.com/methodology