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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 / June 2026 / K260369

510(k) cleared

Dynamis Robotic Surgical System

LEM Surgical AG · Jun 20, 2026 · K260369

FDA cleared the Dynamis Robotic Surgical System from LEM Surgical AG on Jun 20, 2026 under K260369, 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 Feb 5, 2026. The decision came 135 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 LEM Surgical AG in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K260369?

K260369 is the FDA 510(k) for Dynamis Robotic Surgical System, submitted by LEM Surgical AG. FDA's decision date was Jun 20, 2026, under product code OLO (Orthopedic Stereotaxic Instrument).

Who makes the Dynamis Robotic Surgical System?

LEM Surgical AG, based in Berne, is the applicant of record for K260369.

How long did the K260369 review take?

FDA received the submission on Feb 5, 2026 and issued its decision on Jun 20, 2026, 135 days later.

← All decisions in June 2026