Cleared Special

iFuse Bedrock Granite Implant System

K253094 · SI-BONE, Inc. · Orthopedic
Oct 2025
Decision
16d
Days
Class 2
Risk

About This 510(k) Submission

K253094 is an FDA 510(k) clearance for the iFuse Bedrock Granite Implant System, a Sacroiliac Joint Fixation (Class II — Special Controls, product code OUR), submitted by SI-BONE, Inc. (Santa Clara, US). The FDA issued a Cleared decision on October 9, 2025, 16 days after receiving the submission on September 23, 2025. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number K253094 FDA.gov
FDA Decision Cleared SESE
Date Received September 23, 2025
Decision Date October 09, 2025
Days to Decision 16 days
Submission Type Special
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