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THE TAPE

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 / February 2026 / K252733

510(k) cleared

ATLAS Expandable Osteotomy Wedge System

MiRus, LLC · Feb 19, 2026 · K252733 · In the directory

FDA cleared the ATLAS Expandable Osteotomy Wedge System from MiRus, LLC on Feb 19, 2026 under K252733, a traditional 510(k). The device falls under product code PLF, Bone Wedge, regulated at 21 CFR 888.3030 as a Class 2 device. The review panel was Orthopedic.

FDA logged the submission as received on Aug 28, 2025. The decision came 175 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

MiRus, LLC has one other decision in the tracker over the last 12 months: K253444 (EUROPA Posterior Cervical Fusion Navigated Instruments).

Questions & Answers

What did FDA clear under K252733?

K252733 is the FDA 510(k) for ATLAS Expandable Osteotomy Wedge System, submitted by MiRus, LLC. FDA's decision date was Feb 19, 2026, under product code PLF (Bone Wedge).

Who makes the ATLAS Expandable Osteotomy Wedge System?

MiRus, LLC, based in Marietta, GA, is the applicant of record for K252733. The company is listed in the MedDevice Startups directory.

How long did the K252733 review take?

FDA received the submission on Aug 28, 2025 and issued its decision on Feb 19, 2026, 175 days later.

← All decisions in February 2026

Sources

In the startup directory

MiRus

Cardiovascular · Marietta, GA