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FDA 510(k)

ZipToe™ Hammertoe Fusion System

K-Number: K253325 · 2025-12-29

ApplicantToetal Solutions
Decision Date2025-12-29
Product CodeHTY
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ZipToe™ Hammertoe Fusion System is a medical device manufactured by Toetal Solutions. It received FDA 510(k) clearance on 2025-12-29 under approval number K253325. The device is classified under product code HTY. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ZipToe™ Hammertoe Fusion System?

ZipToe™ Hammertoe Fusion System is a medical device that received FDA 510(k) clearance on 2025-12-29. It is manufactured by Toetal Solutions. The 510(k) number is K253325.

When was ZipToe™ Hammertoe Fusion System approved by the FDA?

ZipToe™ Hammertoe Fusion System received FDA 510(k) clearance on 2025-12-29, under approval number K253325.

What company makes ZipToe™ Hammertoe Fusion System?

ZipToe™ Hammertoe Fusion System is manufactured by Toetal Solutions.

What is the FDA product code for ZipToe™ Hammertoe Fusion System?

The FDA product code for ZipToe™ Hammertoe Fusion System is HTY.

Related Clinical Trials

NCT07222787 Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion Outcomes RECRUITING NCT05762055 Prospective Comparative Analysis of ACDF vs Fusion Interbody Cages With nanoLOCK Osseointegrative Technology ENROLLING_BY_INVITATION NCT04305925 Focal Laser Ablation of Prostate Cancer COMPLETED NCT07023393 Proprio Spine Measurement Tool WITHDRAWN NCT07485829 Zimmer Biomet-RibFix Titan RECRUITING NCT02759744 Fusion Guided Focal Laser Ablation of Prostate Cancer ENROLLING_BY_INVITATION

Related Devices (Code: HTY)

K161489Syntorr K-wire and Pin SystemSyntorr, Inc. K160264Additive Orthopaedics Hammertoe Correction SystemAdditive Orthopaedics, LLC K160194StarFuse Interphalangeal PinPhalanx Innovations K152662S-WireSpinal Resources, Inc. K153204In2Bones Kirschner wireIn2bones Sas K152627IFS Fixation Scaffold SystemMetric Medical Devices, 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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