Cleared Traditional

K220195 - iFuse Bedrock Granite Implant System

K220195 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 122-day FDA review.

K220195 · SI-BONE, Inc. · Orthopedic device
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May 2022
Decision
122d
Days
Class 2
Risk

K220195 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 May 26, 2022 after a review of 122 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 K220195 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 24, 2022
Decision Date May 26, 2022
Days to Decision 122 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
At panel average
Panel avg: 122d · This submission: 122d
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 105
Devices cleared under the same product code (OUR) and FDA review panel - the closest regulatory comparables to K220195.
ZESPIN SI Joint Fusion System, Paeon Posterior Cervical Fixation System, Paeon Anterior Cervical Plate System, Spinema Lumbar Plate System
K221050 · Aegis Spine, Inc. · Jun 2022
T-FIX® 3DSI Joint Fusion System
K214123 · Cutting Edge Spine, LLC · Jun 2022
iFuse-TORQ® Implant System
K213667 · SI-BONE, Inc. · Jun 2022
TRELLIS™ SI Joint Fusion System
K212962 · Orthofundamentals, LLC · Apr 2022
Blue Topaz Sacroiliac Screw System
K213590 · Osseus Fusion Systems, LLC · Mar 2022
SIMPACT Sacroiliac Joint Fixation System
K212903 · Life Spine, Inc. · Dec 2021