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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 / July 2026 / K261852

510(k) cleared

OTS Hip

Ortoma AB · Jul 1, 2026 · K261852

FDA cleared the OTS Hip from Ortoma AB on Jul 1, 2026 under K261852, a special 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 Jun 3, 2026. The decision came 28 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for Ortoma AB in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K261852?

K261852 is the FDA 510(k) for OTS Hip, submitted by Ortoma AB. FDA's decision date was Jul 1, 2026, under product code OLO (Orthopedic Stereotaxic Instrument).

Who makes the OTS Hip?

Ortoma AB, based in Gothenburg, is the applicant of record for K261852.

How long did the K261852 review take?

FDA received the submission on Jun 3, 2026 and issued its decision on Jul 1, 2026, 28 days later.

← All decisions in July 2026