Cleared Traditional

K151718 - iFuse Implant System

K151718 is an FDA 510(k) clearance for iFuse Implant System, manufactured by SI-BONE, Inc.. The device is a Class 2 Orthopedic device with product code OUR cleared through the Traditional 510(k) pathway after a 126-day FDA review.

K151718 · SI-BONE, Inc. · Orthopedic device
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Oct 2015
Decision
126d
Days
Class 2
Risk

K151718 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 October 29, 2015 after a review of 126 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

FDA 510(k) Submission Details - K151718

510(k) Number K151718 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 25, 2015
Decision Date October 29, 2015
Days to Decision 126 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
4d slower than avg
Panel avg: 122d · This submission: 126d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

OUR Device Classification - Class 2, Special Controls

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 130
Devices cleared under the same product code (OUR) and FDA review panel - the closest regulatory comparables to K151718.
iFUSE Implant System
K160652 · SI-BONE, Inc. · Jun 2016
iFuse Implant System(R)
K152681 · SI-BONE, Inc. · Mar 2016
The Entasis Dual-Lead Sacroiliac Implant
K152237 · Corelink, LLC · Feb 2016
SI-TECHNOLOGY® SI-DESIS® SCREWS
K151462 · Si-Technology, LLC · Aug 2015
SImmetry Sacroiliac Joint Fusion System
K151818 · Zyga Technology, Inc. · Aug 2015
iFuse Implant System
K150875 · SI-BONE, Inc. · Jul 2015