Cleared Traditional

K150017 - SpineFrontier SIJFuse Sacroiliac Joint Fusion Device System

K150017 is an FDA 510(k) clearance for SpineFrontier SIJFuse Sacroiliac Joint ..., manufactured by Spinefrontier, Inc.. The device is a Class 2 Orthopedic device with 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

FDA 510(k) Submission Details - K150017

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
Combination Product No
PCCP Authorized No
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.

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 Consultant

Empirical Testing Corp
Kenneth C Maxwell

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - OUR Sacroiliac Joint Fixation

All 127
Devices cleared under the same product code (OUR) and FDA review panel - the closest regulatory comparables to K150017.
The Entasis Dual-Lead Sacroiliac Implant
K152237 · Corelink, LLC · Feb 2016
iFuse Implant System
K151718 · SI-BONE, Inc. · Oct 2015
iFuse Implant System
K150875 · SI-BONE, Inc. · Jul 2015
SI-BONE iFuse Implant System
K150714 · SI-BONE, 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