Cleared Traditional

SIros-X System

K252322 · Genesys Spine · Orthopedic
Oct 2025
Decision
89d
Days
Class 2
Risk

About This 510(k) Submission

K252322 is an FDA 510(k) clearance for the SIros-X System, a Sacroiliac Joint Fixation (Class II — Special Controls, product code OUR), submitted by Genesys Spine (Austin, US). The FDA issued a Cleared decision on October 22, 2025, 89 days after receiving the submission on July 25, 2025. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number K252322 FDA.gov
FDA Decision Cleared SESE
Date Received July 25, 2025
Decision Date October 22, 2025
Days to Decision 89 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code OUR — Sacroiliac Joint Fixation
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3040
Definition Sacroiliac Joint Fusion