Hercules Syndesmosis Implant System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K220260 FDA 510(k)
- FDA Product Code
- HTN 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 Hercules Syndesmosis Implant System is a device used to stabilize syndesmotic trauma of the ankle. It consists of UHMWPE suture tensioned between two low profile titanium alloy buttons and is designed to complement plate fixation or to allow use as a stand-alone device.
The device is supplied sterile and is intended for single-use. It is made of UHMWPE sutures and titanium alloy and has been demonstrated to be substantially equivalent to previously cleared devices. The system is authorized with an FDA 510K clearance.
Frequently asked questions
What is the Hercules Syndesmosis Implant System used for?
The Hercules Syndesmosis Implant System is used to stabilize syndesmotic trauma of the ankle, and can be used to complement plate fixation or as a stand-alone device.
Is the Hercules Syndesmosis Implant System sterile?
Yes, the device is supplied sterile and is intended for single-use, reducing the risk of infection.
What materials is the Hercules Syndesmosis Implant System made of?
The system is made of UHMWPE sutures and titanium alloy, which have been demonstrated to be safe and effective for this application.
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. Sources consulted: HERCULES® Knotless Syndesmosis Implant System - CONMED, PDF VP of Quality Assurance and Regulatory Affairs 6000 Poplar Ave, Suite ..., Hercules® A80 ST100 Hercules™ Syndesmosis Implant… - FDA.report
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K220260 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- In2Bones USA, LLC
Sources (1)
- FDA 510(k) K220260 24 fields · synced Sep 27, 2026