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FDA 510(k)

Arthrex DualCompression Hindfoot Fusion Nail Implant System

K-Number: K221031 · 2022-12-20

ApplicantArthrex, Inc.
Decision Date2022-12-20
Product CodeHSB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Arthrex DualCompression Hindfoot Fusion Nail Implant System is a medical device manufactured by Arthrex, Inc.. It received FDA 510(k) clearance on 2022-12-20 under approval number K221031. The device is classified under product code HSB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Arthrex DualCompression Hindfoot Fusion Nail Implant System?

Arthrex DualCompression Hindfoot Fusion Nail Implant System is a medical device that received FDA 510(k) clearance on 2022-12-20. It is manufactured by Arthrex, Inc.. The 510(k) number is K221031.

When was Arthrex DualCompression Hindfoot Fusion Nail Implant System approved by the FDA?

Arthrex DualCompression Hindfoot Fusion Nail Implant System received FDA 510(k) clearance on 2022-12-20, under approval number K221031.

What company makes Arthrex DualCompression Hindfoot Fusion Nail Implant System?

Arthrex DualCompression Hindfoot Fusion Nail Implant System is manufactured by Arthrex, Inc..

What is the FDA product code for Arthrex DualCompression Hindfoot Fusion Nail Implant System?

The FDA product code for Arthrex DualCompression Hindfoot Fusion Nail Implant System is HSB.

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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: HSB)

K161264TRIGEN Low Profile Bone ScrewsSmith & Nephew, Inc. K160545GAP ENDO-EXO MEDULLARY SYSTEMPega Medical, Inc. K161254Renovo Life Small Bone IM Nail SystemRenovo Life, LLC K160167DePuy Synthes TFNA Augmentation SystemSynthes (USA) Products, LLC K160325PRECICE Intramedullary Limb Lengthening SystemEllipse Technologies, Inc. K160267PRECICE Trauma Nail SystemEllipse Technologies, Incorporated

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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