← Back to catalogue

CoLink NeoFuse MIS Plating System

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K241387

by In2Bones, USA

Identifiers

510(k) Number
K241387 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 NeoFuse MIS Plating System is a minimally invasive surgical (MIS) orthopedic plating system designed for internal fixation of long bone fractures. It combines plating technology with modular components to provide stable fixation while minimizing tissue disruption and promoting bone healing through precise alignment and secure attachment.

This system is supplied as a sterile, single-use device intended for use in orthopedic surgical settings. It includes modular plates and screws compatible with MRI safety standards, with sizes and configurations detailed in the attached parts list. Authorized under FDA 510K clearance (K241387) and compliant with MDD and MDR directives, the system is intended for use by trained surgeons in controlled operating environments.

Frequently asked questions

What types of long bone fractures is the CoLink NeoFuse MIS Plating System designed to treat, and how does it differ from traditional plating methods?

The CoLink NeoFuse MIS Plating System is specifically designed for internal fixation of long bone fractures, offering a minimally invasive approach to reduce tissue disruption. Unlike traditional plating methods, which often require larger incisions and more extensive soft tissue manipulation, this system uses modular plates and screws to achieve stable fixation with precision alignment. Its minimally invasive design aims to promote faster healing by minimizing trauma to surrounding tissues while maintaining secure attachment for proper bone alignment.

Is the CoLink NeoFuse MIS Plating System reusable, or is it intended for single-use only? How does this impact its sterility?

The CoLink NeoFuse MIS Plating System is explicitly supplied as a sterile, single-use device. This design ensures patient safety by eliminating the risk of cross-contamination or degradation from reuse, which can occur with reprocessed instruments. Single-use also aligns with modern surgical best practices for orthopedic implants, reducing the need for sterilization validation and simplifying inventory management.

What sizes and configurations are available for the CoLink NeoFuse MIS Plating System, and how do I determine the right fit for a patient?

The available sizes and configurations for the CoLink NeoFuse MIS Plating System are detailed in the attached parts list, which includes modular plates and screws tailored for specific long bone applications. To determine the correct fit, surgeons should refer to the parts list alongside preoperative imaging and clinical assessment. The modular design allows for customization to match fracture patterns, bone anatomy, and surgical approach, ensuring optimal stability and alignment.

How should the CoLink NeoFuse MIS Plating System be stored, and are there any special handling requirements before use?

Since the system is sterile and single-use, it should be stored in its original, sealed packaging in a clean, dry environment away from direct sunlight or extreme temperatures. The packaging must remain intact until immediately before use to preserve sterility. Surgeons should follow the manufacturer’s instructions for opening the sterile barrier and handling components to prevent contamination, as improper storage or handling could compromise the device’s integrity.

Does the CoLink NeoFuse MIS Plating System comply with MRI safety standards, and if so, how does this benefit patients?

Yes, the CoLink NeoFuse MIS Plating System includes modular components compatible with MRI safety standards, meaning they are designed to be non-ferromagnetic or low-risk for MRI procedures. This compliance is critical for patients who may require postoperative imaging, as it reduces the risk of artifacts or complications during MRI scans. The system’s MRI-safe design ensures that patients can undergo follow-up imaging without the need for implant removal or alternative diagnostic methods.

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

MDD

European Union Active

MDR

United States Active

FDA_510K

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
In2Bones, USA
FDA Applicant
In2bones USA

Sources (2)

  • FDA 510(k) K241387 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced May 19, 2026