Cleared Special

K160124 - LUMIS Cannulated Pedicle Screw Fixation...

K160124 is an FDA 510(k) clearance for LUMIS Cannulated Pedicle Screw Fixation..., manufactured by Spinevision S.A.. The device is a Class 2 Orthopedic device with product code MNI cleared through the Special 510(k) pathway after a 75-day FDA review.

K160124 · Spinevision S.A. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2016
Decision
75d
Days
Class 2
Risk

K160124 is an FDA 510(k) clearance for the LUMIS Cannulated Pedicle Screw Fixation System, U.L.I.S. Pedicle Screw Fixati.... Classified as Orthosis, Spinal Pedicle Fixation (product code MNI), Class II - Special Controls.

Submitted by Spinevision S.A. (Antony, FR). The FDA issued a Cleared decision on April 4, 2016 after a review of 75 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3070 - 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 Spinevision S.A. devices

FDA 510(k) Submission Details - K160124

510(k) Number K160124 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 20, 2016
Decision Date April 04, 2016
Days to Decision 75 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
47d faster than avg
Panel avg: 122d · This submission: 75d
Pathway characteristics
Modification to existing cleared device.

MNI Device Classification - Class 2, Special Controls

Product Code MNI Orthosis, Spinal Pedicle Fixation
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3070
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 - MNI Orthosis, Spinal Pedicle Fixation

All 194
Devices cleared under the same product code (MNI) and FDA review panel - the closest regulatory comparables to K160124.
MySpine Pedicle Screw Placement Guides - LP
K153273 · Medacta International S.A. · Jun 2016
Sniper (R) Spine System
K160003 · Spine Wave, Inc. · Feb 2016
X-spine Pedicle Screw System
K152132 · X-Spine Systems, Inc. · Sep 2015
Reliance Spinal Screw System
K152131 · Reliance Medical Systems, LLC · Sep 2015
Sniper Spine System
K152174 · Spine Wave, Inc. · Aug 2015
Sniper Spine System
K151813 · Spine Wave, Inc. · Jul 2015