Cleared Special

K191757 - EUROPA Pedicle Screw System

K191757 is the FDA 510(k) clearance for EUROPA Pedicle Screw System by MiRus, LLC. It is a Class 2 Orthopedic device (product code NKB) cleared through the Special 510(k) pathway after a 18-day FDA review.

K191757 · MiRus, LLC · Orthopedic device
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Jul 2019
Decision
18d
Days
Class 2
Risk

K191757 is an FDA 510(k) clearance for the EUROPA Pedicle Screw System. Classified as Thoracolumbosacral Pedicle Screw System within the NKB classification (a category for thoracolumbosacral pedicle screw systems), Class II - Special Controls.

Submitted by MiRus, LLC (Marietta, US). The FDA issued a Cleared decision on July 19, 2019 after a review of 18 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 MiRus, LLC devices

Submission Details

510(k) Number K191757 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 01, 2019
Decision Date July 19, 2019
Days to Decision 18 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
104d faster than avg
Panel avg: 122d · This submission: 18d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code NKB Thoracolumbosacral Pedicle Screw System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3070
Definition Intended To Provide Immobilization And Stabilization Of Spinal Segments In Thoracic, Lumbar, And Sacral Spine As An Adjunct To 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 - NKB Thoracolumbosacral Pedicle Screw System

All 649
Devices cleared under the same product code (NKB) and FDA review panel - the closest regulatory comparables to K191757.
Elaris Pedicle Screw System
K183091 · Spinewelding AG · Aug 2019
4CIS® Chiron Spinal Fixation System
K190471 · Solco Biomedical Co., Ltd. · Jul 2019
Mariner MIS Pedicle Screw System
K191648 · SeaSpine Orthopedics Corporation · Jul 2019
Salvo™ Spine System
K191045 · Spine Wave, Inc. · Jul 2019
LineSider™ Spinal System
K190360 · Integrity Implants, Inc. · Jun 2019
VADER® one Pedicle System MIS and LightMore® Pedicle System 6.0
K190545 · Icotec AG · Jun 2019