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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 / November 2025 / K251365

510(k) cleared

OptumSI Implant System

Si Solutions, LLC · Nov 20, 2025 · K251365

FDA cleared the OptumSI Implant System from Si Solutions, LLC on Nov 20, 2025 under K251365, a traditional 510(k). The device falls under product code OUR, Sacroiliac Joint Fixation, regulated at 21 CFR 888.3040 as a Class 2 device. The review panel was Orthopedic.

FDA logged the submission as received on May 1, 2025. The decision came 203 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 Si Solutions, LLC in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K251365?

K251365 is the FDA 510(k) for OptumSI Implant System, submitted by Si Solutions, LLC. FDA's decision date was Nov 20, 2025, under product code OUR (Sacroiliac Joint Fixation).

Who makes the OptumSI Implant System?

Si Solutions, LLC, based in Columbia, MO, is the applicant of record for K251365.

How long did the K251365 review take?

FDA received the submission on May 1, 2025 and issued its decision on Nov 20, 2025, 203 days later.

← All decisions in November 2025