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Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register

The Tracker / December 2025 / K253325

510(k) cleared

ZipToe Hammertoe Fusion System

Toetal Solutions · Dec 29, 2025 · K253325

FDA cleared the ZipToe Hammertoe Fusion System from Toetal Solutions on Dec 29, 2025 under K253325, a traditional 510(k). The device falls under product code HTY, Pin, Fixation, Smooth, regulated at 21 CFR 888.3040 as a Class 2 device. The review panel was Orthopedic.

FDA logged the submission as received on Sep 30, 2025. The decision came 90 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for Toetal Solutions in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K253325?

K253325 is the FDA 510(k) for ZipToe Hammertoe Fusion System, submitted by Toetal Solutions. FDA's decision date was Dec 29, 2025, under product code HTY (Pin, Fixation, Smooth).

Who makes the ZipToe Hammertoe Fusion System?

Toetal Solutions, based in Malvern, PA, is the applicant of record for K253325.

How long did the K253325 review take?

FDA received the submission on Sep 30, 2025 and issued its decision on Dec 29, 2025, 90 days later.

← All decisions in December 2025