Cleared Traditional

OptumSI Implant System

K251365 · Si Solutions, LLC · Orthopedic

Nov 2025

Decision

203d

Days

Class 2

Risk

About This 510(k) Submission

K251365 is an FDA 510(k) clearance for the OptumSI Implant System, a Sacroiliac Joint Fixation (Class II — Special Controls, product code OUR), submitted by Si Solutions, LLC (Columbia, US). The FDA issued a Cleared decision on November 20, 2025, 203 days after receiving the submission on May 1, 2025. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number	K251365 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 01, 2025
Decision Date	November 20, 2025
Days to Decision	203 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF