Cleared Traditional

K150875 - iFuse Implant System

K150875 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 112-day FDA review.

K150875 · SI-BONE, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2015
Decision
112d
Days
Class 2
Risk

K150875 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. (San Jose, US). The FDA issued a Cleared decision on July 22, 2015 after a review of 112 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 K150875 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 01, 2015
Decision Date July 22, 2015
Days to Decision 112 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
10d faster than avg
Panel avg: 122d · This submission: 112d
Pathway characteristics
Predicate-based equivalence.

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. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Orthopedic devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov
NCT01640353 Completed Observational Industry-sponsored

Sacroiliac Joint Fusion With iFuse Implant System (SIFI)

194
Patients (actual)
26
Sites
Condition studied Degenerative Sacroiliitis; Sacroiliac Joint Disruption
Eligibility All sexes · 21 Years+
Principal investigator Bradley Duhon, MD
Sponsor SI-BONE, Inc. (industry)
Started 2012-07-01 → Primary completion 2015-01-01 → Completed 2016-02-01
Primary outcome
Subject Success
Secondary outcome
Change in SI Joint Pain on Visual Analog Scale (VAS) (0-100 mm)
View full study on ClinicalTrials.gov

Regulatory Peers - OUR Sacroiliac Joint Fixation

All 118
Devices cleared under the same product code (OUR) and FDA review panel - the closest regulatory comparables to K150875.
iFuse Implant System(R)
K152681 · SI-BONE, Inc. · Mar 2016
The Entasis Dual-Lead Sacroiliac Implant
K152237 · Corelink, LLC · Feb 2016
iFuse Implant System
K151718 · SI-BONE, Inc. · Oct 2015
SI-BONE iFuse Implant System
K150714 · SI-BONE, Inc. · Apr 2015
LIFE SPINE SACROILIAC JOINT FIXATION SYSTEM
K141246 · Life Spine, Inc. · Feb 2015
IFUSE IMPLANT SYSTEM
K141049 · SI-BONE, Inc. · Jul 2014