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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 / February 2026 / K252058

510(k) cleared

ROSA Knee System with UltraSound Imaging Platform (USIP)

Balmoral Medical, LLC · Feb 6, 2026 · K252058

FDA cleared the ROSA Knee System with UltraSound Imaging Platform (USIP) from Balmoral Medical, LLC on Feb 6, 2026 under K252058, a traditional 510(k). The device falls under product code OLO, Orthopedic Stereotaxic Instrument, regulated at 21 CFR 882.4560 as a Class 2 device. The review panel was Neurology.

FDA logged the submission as received on Jul 1, 2025. The decision came 220 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for Balmoral Medical, LLC in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K252058?

K252058 is the FDA 510(k) for ROSA Knee System with UltraSound Imaging Platform (USIP), submitted by Balmoral Medical, LLC. FDA's decision date was Feb 6, 2026, under product code OLO (Orthopedic Stereotaxic Instrument).

Who makes the ROSA Knee System with UltraSound Imaging Platform (USIP)?

Balmoral Medical, LLC, based in Rosemont, IL, is the applicant of record for K252058.

How long did the K252058 review take?

FDA received the submission on Jul 1, 2025 and issued its decision on Feb 6, 2026, 220 days later.

← All decisions in February 2026