Cleared Special

K150714 - SI-BONE iFuse Implant System

K150714 is an FDA 510(k) clearance for SI-BONE iFuse Implant System, manufactured by SI-BONE, Inc.. The device is a Class 2 Orthopedic device with product code OUR cleared through the Special 510(k) pathway after a 29-day FDA review.

K150714 · SI-BONE, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2015
Decision
29d
Days
Class 2
Risk

K150714 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. (San Jose, US). The FDA issued a Cleared decision on April 17, 2015 after a review of 29 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all SI-BONE, Inc. devices

FDA 510(k) Submission Details - K150714

510(k) Number K150714 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 19, 2015
Decision Date April 17, 2015
Days to Decision 29 days
Submission Type Special
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
93d faster than avg
Panel avg: 122d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

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 K150714.
SImmetry Sacroiliac Joint Fusion System
K151818 · Zyga Technology, Inc. · Aug 2015
iFuse Implant System
K150875 · SI-BONE, Inc. · Jul 2015
SpineFrontier SIJFuse Sacroiliac Joint Fusion Device System
K150017 · Spinefrontier, Inc. · Apr 2015
LIFE SPINE SACROILIAC JOINT FIXATION SYSTEM
K141246 · Life Spine, Inc. · Feb 2015
SImmetry Sacroiliac Joint Fusion System
K141549 · Zyga Technology, Inc. · Jan 2015
FRONTIER DEVICES FUSIO SCREW FUZE SYSTEM
K141106 · Folsom Metal Products, Inc. Dba Frontier Devices · Oct 2014