Cleared Special

K092375 - MODIFICATION TO SI JOINT FUSION SYSTEM

K092375 is an FDA 510(k) clearance for MODIFICATION TO SI JOINT FUSION 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 30-day FDA review.

K092375 · SI-BONE, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2009
Decision
30d
Days
Class 2
Risk

K092375 is an FDA 510(k) clearance for the MODIFICATION TO SI JOINT FUSION SYSTEM. Classified as Sacroiliac Joint Fixation (product code OUR), Class II - Special Controls.

Submitted by SI-BONE, Inc. (Washington, US). The FDA issued a Cleared decision on September 4, 2009 after a review of 30 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 - K092375

510(k) Number K092375 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 05, 2009
Decision Date September 04, 2009
Days to Decision 30 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
92d faster than avg
Panel avg: 122d · This submission: 30d
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 119
Devices cleared under the same product code (OUR) and FDA review panel - the closest regulatory comparables to K092375.
IFUSE IMPLANT SYSTEM
K122074 · SI-BONE, Inc. · Oct 2012
SI-FIX SACROILIAC JOINT FUSION SYSTEM
K110472 · Medtronic Sofamor Danek · May 2012
IFUSE IMPLANT SYSTEM
K110838 · SI-BONE, Inc. · Apr 2011
SI JOINT FUSION SYSTEM
K080398 · SI-BONE, Inc. · Nov 2008
SIJF CANNULATED SCREW SYSTEM
K051296 · Depuy Spine, Inc. · Aug 2005