Cleared Traditional

K190230 - iFuse Implant System

K190230 is the FDA 510(k) clearance for 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 56-day FDA review.

K190230 · SI-BONE, Inc. · Orthopedic device
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Apr 2019
Decision
56d
Days
Class 2
Risk

K190230 is an FDA 510(k) clearance for the 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 April 3, 2019 after a review of 56 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all SI-BONE, Inc. devices

Submission Details

510(k) Number K190230 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 06, 2019
Decision Date April 03, 2019
Days to Decision 56 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
66d faster than avg
Panel avg: 122d · This submission: 56d
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 Consultant

Domecus Consulting Services, LLC
Cindy Domecus

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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 K190230.
Genesys Spine Sacroiliac Joint Fusion System
K191748 · Genesys Spine · Sep 2019
EVOL® -SI Joint Fusion System
K190025 · Cutting Edge Spine, LLC · Aug 2019
SambaScrew 3D SI Fusion System
K183342 · Orthofix, Inc. · Apr 2019
SI-LOK® Sacroiliac Joint Fixation System, Navigation Instruments, ExcelsiusGPS® Instruments
K183119 · Globus Medical, Inc. · Feb 2019
SI-Restore® Sacroiliac Joint Fixation System
K182919 · Biofusion Medical · Jan 2019
iFuse Implant System®
K182983 · SI-BONE, Inc. · Nov 2018