Triway Tibiotalocalcaneal (TTC) Arthrodesis System
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
by In2Bones SAS
Identifiers
- 510(k) Number
- K173811 FDA 510(k)
- FDA Product Code
- HSB FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 888.3020 FDA 510(k)
- Regulation Number
- 888.3020 FDA 510(k)
- Advisory Committee
- Orthopedic FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Triway Tibiotalocalcaneal (TTC) Arthrodesis System is a surgical implant designed for the fusion of the tibia, talus, and calcaneus bones in the ankle joint, classified under orthopedic arthrodesis devices. It stabilizes the hindfoot and ankle complex to promote bony union and restore mechanical alignment in complex ankle pathologies, such as severe arthritis or deformities requiring rigid fixation.
This system is supplied sterile and intended for single-use, featuring components compatible with MRI imaging environments. It includes modular implants and instrumentation tailored for precise placement in TTC arthrodesis procedures, with sizes and configurations detailed in the accompanying surgical technique guide. Authorized under FDA 510(k) clearance (K173811), it adheres to EU MDR and MDD regulatory standards, ensuring compliance with orthopedic implant requirements for surgical applications.
Frequently asked questions
What types of complex ankle conditions is the Triway TTC Arthrodesis System specifically designed to address in surgical settings?
The Triway TTC Arthrodesis System is designed for surgical fusion of the tibia, talus, and calcaneus bones to address severe ankle pathologies requiring rigid fixation. This includes complex cases like advanced arthritis or significant deformities in the ankle joint, where stabilizing the hindfoot and ankle complex is critical to promote bony union and restore mechanical alignment.
Is the Triway TTC Arthrodesis System compatible with MRI scans, and how does this affect its use in postoperative care?
Yes, the Triway TTC Arthrodesis System is explicitly designed with components that are MRI-compatible, allowing for safe imaging in postoperative care. This feature ensures patients can undergo MRI scans without risking damage to the implant or interference with diagnostic imaging, which is particularly useful for monitoring bone healing and alignment.
Are the implants in the Triway TTC Arthrodesis System reusable, or is this a single-use system?
The Triway TTC Arthrodesis System is intended for single-use only, as explicitly stated in the product description. This ensures sterility and reduces the risk of cross-contamination between patients, which is critical in surgical settings where infection control is paramount.
How are the implants and instrumentation supplied, and what resources are available to guide their precise placement during surgery?
The system is supplied sterile and includes modular implants along with specialized instrumentation tailored for TTC arthrodesis procedures. Detailed guidance for precise placement is provided in the accompanying surgical technique guide, which outlines the sizes and configurations of the implants to ensure proper use during surgery.
What regulatory pathways does the Triway TTC Arthrodesis System follow in the U.S. and Europe, and how does this impact its availability?
In the U.S., the system has received FDA 510(k) clearance under the traditional review pathway (K173811), confirming it is substantially equivalent to a legally marketed device. In Europe, it complies with both the Medical Device Directive (MDD) and the Medical Device Regulation (MDR), ensuring it meets stringent orthopedic implant requirements for surgical applications. These regulatory clearances directly impact its availability by validating its safety, performance, and compliance with regional standards.
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
MDR
MDD
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| EUDAMED | European Union | MDD | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K173811 | Class II | Active |
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Manufacturer
- Manufacturer
- In2Bones SAS
Sources (2)
- FDA 510(k) K173811 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 18, 2026