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CoLink Afx Plating System

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K181113

by In2Bones USA, LLC

Identifiers

510(k) Number
K181113 FDA 510(k)
FDA Product Code
HRS FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 888.3030 FDA 510(k)
Regulation Number
888.3030 FDA 510(k)
Advisory Committee
Orthopedic FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The CoLink Afx Plating System is a modular orthopedic fixation device designed for internal fixation of long bone fractures. It features a locking plate system with angled and straight screws to provide stable fixation and promote bone healing through precise alignment and compression.

This system is supplied as a reusable surgical instrument set, intended for use in orthopedic procedures under sterile conditions. It is classified under the Product Code HRS (Hardware for Orthopedic Reconstruction and Repair) and is authorised for use in the United States via FDA 510(k) clearance under the Traditional pathway. The system is intended for use in MRI-safe environments, adhering to established regulatory standards for orthopedic hardware.

Frequently asked questions

What types of long bone fractures is the CoLink Afx Plating System designed to treat, and how does it promote bone healing?

The CoLink Afx Plating System is designed for internal fixation of long bone fractures, providing stable fixation through a modular locking plate system. It uses angled and straight screws to achieve precise alignment and compression, which helps promote bone healing by maintaining proper fracture reduction and reducing micromotion at the fracture site.

Is the CoLink Afx Plating System intended for single-use or reusable applications, and how should it be handled to maintain sterility?

The CoLink Afx Plating System is supplied as a reusable surgical instrument set, intended for use in orthopedic procedures under sterile conditions. To maintain sterility, it must be properly sterilized between uses following established medical device reprocessing protocols, as it is not designed for single-use.

How is the CoLink Afx Plating System authorized for use in the United States, and what regulatory pathway was followed?

The CoLink Afx Plating System received FDA 510(k) clearance under the Traditional pathway, demonstrating substantial equivalence to a legally marketed predicate device. The clearance was granted by the Orthopedic (OR) Advisory Committee and classified under Product Code HRS (Hardware for Orthopedic Reconstruction and Repair).

Can this system be used in MRI environments, and if so, what safety standards does it meet?

Yes, the CoLink Afx Plating System is designed for use in MRI-safe environments. It adheres to established regulatory standards for orthopedic hardware to ensure compatibility with MRI procedures, reducing the risk of artifacts or interference during imaging.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDR

United States Active

FDA_510K

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Manufacturer

Manufacturer
In2Bones USA, LLC

Sources (2)

  • FDA 510(k) K181113 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced May 18, 2026