Cleared Special

K160124 - LUMIS Cannulated Pedicle Screw Fixation System, U.L.I.S. Pedicle Screw Fixation System

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) Official FDA 510(k) Summary (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.

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
Combination Product No
PCCP Authorized No
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 302
Devices cleared under the same product code (MNI) and FDA review panel - the closest regulatory comparables to K160124.
LumFix Spinal Fixation Sytem
K160731 · CG Bio Co., Ltd. · Oct 2016
Double Medical Universal Spine System
K151458 · Double Medical Technology, Inc. · Aug 2016
MySpine Pedicle Screw Placement Guides - LP
K153273 · Medacta International S.A. · Jun 2016
Premier
K160320 · Shandong Weigao Orthopaedic Device Co., Ltd. · Apr 2016
Sniper (R) Spine System
K160003 · Spine Wave, Inc. · Feb 2016
YAHUA Spinal System
K152324 · Beijing Weigao Yahua Artificial Joint Development Co. , Ltd. · Feb 2016