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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 / September 2025 / K252657

510(k) cleared

Impact PEEK Union Nail System

Nvision Biomedical Technologies, Inc. · Sep 19, 2025 · K252657

FDA cleared the Impact PEEK Union Nail System from Nvision Biomedical Technologies, Inc. on Sep 19, 2025 under K252657, a special 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 Aug 22, 2025. The decision came 28 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), K253423 (ToeJack MIS Bunion System).

Questions & Answers

What did FDA clear under K252657?

K252657 is the FDA 510(k) for Impact PEEK Union Nail System, submitted by Nvision Biomedical Technologies, Inc.. FDA's decision date was Sep 19, 2025, under product code HTY (Pin, Fixation, Smooth).

Who makes the Impact PEEK Union Nail System?

Nvision Biomedical Technologies, Inc., based in San Antonio, TX, is the applicant of record for K252657.

How long did the K252657 review take?

FDA received the submission on Aug 22, 2025 and issued its decision on Sep 19, 2025, 28 days later.

← All decisions in September 2025

Sources