Cleared Traditional

K222774 - iFuse Bedrock Granite Implant System

K222774 is the FDA 510(k) clearance for iFuse Bedrock Granite Implant System by SI-BONE, Inc.. It is a Class 2 Orthopedic device (product code OUR) cleared through the Traditional 510(k) pathway after a 99-day FDA review.

K222774 · SI-BONE, Inc. · Orthopedic device
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Dec 2022
Decision
99d
Days
Class 2
Risk

K222774 is an FDA 510(k) clearance for the iFuse Bedrock Granite® Implant System. Classified as Sacroiliac Joint Fixation (product code OUR), Class II - Special Controls.

Submitted by SI-BONE, Inc. (Santa Clara, US). The FDA issued a Cleared decision on December 22, 2022 after a review of 99 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3040 - the FDA orthopedic device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all SI-BONE, Inc. devices

Submission Details

510(k) Number K222774 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 14, 2022
Decision Date December 22, 2022
Days to Decision 99 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
23d faster than avg
Panel avg: 122d · This submission: 99d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code OUR Sacroiliac Joint Fixation
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3040
Definition Sacroiliac Joint Fusion
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Orthopedic devices follow this clearance model.

Regulatory Peers - OUR Sacroiliac Joint Fixation

All 103
Devices cleared under the same product code (OUR) and FDA review panel - the closest regulatory comparables to K222774.
Entasis 3D Dual-Lead Sacroiliac Implant System
K223708 · Corelink, LLC · Mar 2023
ZESPIN SI Joint Fusion System
K223521 · Aegis Spine, Inc. · Jan 2023
SI-Cure Sacroiliac Joint Fusion System
K223819 · Alevio, LLC · Jan 2023
CASSATT™ SIJ Fixation System
K211785 · Ctl Medical Corporation · Oct 2022
UNITY Sacroiliac Joint Fixation System
K222448 · Dio Medical Corporation · Oct 2022
SILO TFX MIS Sacroiliac Joint Fixation System
K221047 · Aurora Spine, Inc. · Oct 2022