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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 / November 2025 / K253423

510(k) cleared

ToeJack MIS Bunion System

Nvision Biomedical Technologies, Inc. · Nov 18, 2025 · K253423

FDA cleared the ToeJack MIS Bunion System from Nvision Biomedical Technologies, Inc. on Nov 18, 2025 under K253423, a traditional 510(k). The device falls under product code HRS, Plate, Fixation, Bone, regulated at 21 CFR 888.3030 as a Class 2 device. The review panel was Orthopedic.

FDA logged the submission as received on Sep 25, 2025. The decision came 54 days later, inside the 90 FDA-day goal for a 510(k).

Nvision Biomedical Technologies, Inc. has 3 other decisions in the tracker over the last 12 months: K253718 (enHAnce PEEK Bunion System), K260291 (Vortex5 Tailor's Bunion Correction System), K252657 (Impact PEEK Union Nail System).

Questions & Answers

What did FDA clear under K253423?

K253423 is the FDA 510(k) for ToeJack MIS Bunion System, submitted by Nvision Biomedical Technologies, Inc.. FDA's decision date was Nov 18, 2025, under product code HRS (Plate, Fixation, Bone).

Who makes the ToeJack MIS Bunion System?

Nvision Biomedical Technologies, Inc., based in San Antonio, TX, is the applicant of record for K253423.

How long did the K253423 review take?

FDA received the submission on Sep 25, 2025 and issued its decision on Nov 18, 2025, 54 days later.

← All decisions in November 2025

Sources