Cleared Traditional

K150017 - SpineFrontier SIJFuse Sacroiliac Joint ...

K150017 is the FDA 510(k) clearance for SpineFrontier SIJFuse Sacroiliac Joint ... by Spinefrontier, Inc.. It is a Class 2 Orthopedic device (product code OUR) cleared through the Traditional 510(k) pathway after a 109-day FDA review.

K150017 · Spinefrontier, Inc. · Orthopedic device
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Apr 2015
Decision
109d
Days
Class 2
Risk

K150017 is an FDA 510(k) clearance for the SpineFrontier SIJFuse Sacroiliac Joint Fusion Device System. Classified as Sacroiliac Joint Fixation (product code OUR), Class II - Special Controls.

Submitted by Spinefrontier, Inc. (Beverly, US). The FDA issued a Cleared decision on April 24, 2015 after a review of 109 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 Spinefrontier, Inc. devices

Submission Details

510(k) Number K150017 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 05, 2015
Decision Date April 24, 2015
Days to Decision 109 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
13d faster than avg
Panel avg: 122d · This submission: 109d
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 Peers - OUR Sacroiliac Joint Fixation

All 103
Devices cleared under the same product code (OUR) and FDA review panel - the closest regulatory comparables to K150017.
M.U.S.T. Sacral Iliac Screw and Pelvic Trauma System
K171595 · Medacta International S.A. · Aug 2017
PathLoc-SI Joint Fusion System
K153656 · L & K Biomed Co., Ltd. · Nov 2016
RIALTO(TM) SI Fusion System, Medtronic Reusable Instruments for Use with the IPC(TM) Powerease(TM) System, and Medtronic Navigated Manual Reusable Instruments for use with the StealthStation(TM) and IPC(TM) Powerease(TM) Systems
K161210 · Medtronic Sofamor Danek · Aug 2016
LIFE SPINE SACROILIAC JOINT FIXATION SYSTEM
K141246 · Life Spine, Inc. · Feb 2015
SI-FIX SACROILIAC JOINT FUSION SYSTEM
K110472 · Medtronic Sofamor Danek · May 2012
SIJF CANNULATED SCREW SYSTEM
K051296 · Depuy Spine, Inc. · Aug 2005