Cleared Traditional

K193524 - SI-BONE iFuse Implant System

K193524 is the FDA 510(k) clearance for SI-BONE iFuse 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 103-day FDA review.

K193524 · SI-BONE, Inc. · Orthopedic device
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Mar 2020
Decision
103d
Days
Class 2
Risk

K193524 is an FDA 510(k) clearance for the SI-BONE iFuse 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 March 31, 2020 after a review of 103 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 K193524 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 19, 2019
Decision Date March 31, 2020
Days to Decision 103 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
19d faster than avg
Panel avg: 122d · This submission: 103d
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 K193524.
NADIA SI Fusion System
K190580 · Ilion Medical, Inc. · Aug 2020
SI-Restore Sacroiliac Joint Fixation System
K200868 · Biofusion Medical · Apr 2020
FIREBIRD SI Fusion System
K200696 · Orthofix, Inc. · Apr 2020
M.U.S.T. Sacral Illiac Screw and Pelvic Trauma System
K193083 · Medacta International S.A. · Dec 2019
Genesys Spine Sacroiliac Joint Fusion System
K191748 · Genesys Spine · Sep 2019
EVOL® -SI Joint Fusion System
K190025 · Cutting Edge Spine, LLC · Aug 2019