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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 / K261031

510(k) cleared

POSEIDON ST

Signus Medinzintechnik GmbH · Jul 10, 2026 · K261031

FDA cleared the POSEIDON ST from Signus Medinzintechnik GmbH on Jul 10, 2026 under K261031, a traditional 510(k). The device falls under product code MQP, Spinal Vertebral Body Replacement Device, regulated at 21 CFR 888.3060 as a Class 2 device. The review panel was Orthopedic.

FDA logged the submission as received on Mar 30, 2026. The decision came 102 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 Signus Medinzintechnik GmbH in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K261031?

K261031 is the FDA 510(k) for POSEIDON ST, submitted by Signus Medinzintechnik GmbH. FDA's decision date was Jul 10, 2026, under product code MQP (Spinal Vertebral Body Replacement Device).

Who makes the POSEIDON ST?

Signus Medinzintechnik GmbH, based in Alzenau, is the applicant of record for K261031.

How long did the K261031 review take?

FDA received the submission on Mar 30, 2026 and issued its decision on Jul 10, 2026, 102 days later.

← All decisions in July 2026