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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 / October 2025 / K252322

510(k) cleared

SIros-X System

Genesys Spine · Oct 22, 2025 · K252322

FDA cleared the SIros-X System from Genesys Spine on Oct 22, 2025 under K252322, 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 Jul 25, 2025. The decision came 89 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for Genesys Spine in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K252322?

K252322 is the FDA 510(k) for SIros-X System, submitted by Genesys Spine. FDA's decision date was Oct 22, 2025, under product code OUR (Sacroiliac Joint Fixation).

Who makes the SIros-X System?

Genesys Spine, based in Austin, TX, is the applicant of record for K252322.

How long did the K252322 review take?

FDA received the submission on Jul 25, 2025 and issued its decision on Oct 22, 2025, 89 days later.

← All decisions in October 2025