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FDA 510(k)

Hercules Syndesmosis Implant System

K-Number: K220260 · 2022-03-31

ApplicantIn2bones USA, LLC
Decision Date2022-03-31
Product CodeHTN
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Hercules Syndesmosis Implant System is a medical device manufactured by In2bones USA, LLC. It received FDA 510(k) clearance on 2022-03-31 under approval number K220260. The device is classified under product code HTN. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Hercules Syndesmosis Implant System?

Hercules Syndesmosis Implant System is a medical device that received FDA 510(k) clearance on 2022-03-31. It is manufactured by In2bones USA, LLC. The 510(k) number is K220260.

When was Hercules Syndesmosis Implant System approved by the FDA?

Hercules Syndesmosis Implant System received FDA 510(k) clearance on 2022-03-31, under approval number K220260.

What company makes Hercules Syndesmosis Implant System?

Hercules Syndesmosis Implant System is manufactured by In2bones USA, LLC.

What is the FDA product code for Hercules Syndesmosis Implant System?

The FDA product code for Hercules Syndesmosis Implant System is HTN.

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Related PubMed Literature

PMID: 39892748 Long-term Safety and Performance of a Suprachoroidal Pressure Sensor System: Results of the EYEMATE-SC Trial Follow-up Study. Ophthalmology (2025) PMID: 41966145 From Registry to Reality: Opportunities to Enhance Post-market Surveillance of High-Risk Medical Devices Comment on "Quality and Utility of European Cardiovascular and Orthopaedic Registries for the Regulatory Evaluation of Medical Device Safety and Performance Across the Implant Lifecycle: A Systematic Review". International journal of health policy and management (2025) PMID: 39726899 How to improve the mechanical safety of a novel spinal implant while saving costs and time. JOR spine (2024)

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Related Devices (Code: HTN)

K153211M-Fix Acromioclavicular DeviceCoracoid Solutions, Inc. K173550Akros FibuLink™ Syndesmosis Repair KitAkros Medical K172620SyndesMetrics Syndesmosis Repair SystemMortise Medical, LLC K170249GRAVITY™ Syndesmosis LPWrightmedicaltechnologyinc K162996INVISIKNOT Ankle Syndesmosis Repair KitSmith & Nephew, Inc. K170440KISSloc Suture SystemArthrosurface, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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