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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 / March 2026 / K260291

510(k) cleared

Vortex5 Tailor's Bunion Correction System

Nvision Biomedical Technologies, Inc. · Mar 25, 2026 · K260291

FDA cleared the Vortex5 Tailor's Bunion Correction System from Nvision Biomedical Technologies, Inc. on Mar 25, 2026 under K260291, 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 Jan 29, 2026. The decision came 55 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), K253423 (ToeJack MIS Bunion System), K252657 (Impact PEEK Union Nail System).

Questions & Answers

What did FDA clear under K260291?

K260291 is the FDA 510(k) for Vortex5 Tailor's Bunion Correction System, submitted by Nvision Biomedical Technologies, Inc.. FDA's decision date was Mar 25, 2026, under product code HRS (Plate, Fixation, Bone).

Who makes the Vortex5 Tailor's Bunion Correction System?

Nvision Biomedical Technologies, Inc., based in San Antonio, TX, is the applicant of record for K260291.

How long did the K260291 review take?

FDA received the submission on Jan 29, 2026 and issued its decision on Mar 25, 2026, 55 days later.

← All decisions in March 2026

Sources