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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 / April 2026 / K253718

510(k) cleared

enHAnce PEEK Bunion System

Nvision Biomedical Technologies, Inc. · Apr 1, 2026 · K253718

FDA cleared the enHAnce PEEK Bunion System from Nvision Biomedical Technologies, Inc. on Apr 1, 2026 under K253718, 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 Nov 24, 2025. The decision came 128 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Nvision Biomedical Technologies, Inc. has 3 other decisions in the tracker over the last 12 months: K260291 (Vortex5 Tailor's Bunion Correction System), K253423 (ToeJack MIS Bunion System), K252657 (Impact PEEK Union Nail System).

Questions & Answers

What did FDA clear under K253718?

K253718 is the FDA 510(k) for enHAnce PEEK Bunion System, submitted by Nvision Biomedical Technologies, Inc.. FDA's decision date was Apr 1, 2026, under product code HRS (Plate, Fixation, Bone).

Who makes the enHAnce PEEK Bunion System?

Nvision Biomedical Technologies, Inc., based in San Antonio, TX, is the applicant of record for K253718.

How long did the K253718 review take?

FDA received the submission on Nov 24, 2025 and issued its decision on Apr 1, 2026, 128 days later.

← All decisions in April 2026

Sources