Cleared Traditional

K182417 - ROSA ONE Brain Application

K182417 is the FDA 510(k) clearance for ROSA ONE Brain Application by Medtech S.A. It is a Class 2 Neurology device (product code HAW) cleared through the Traditional 510(k) pathway after a 155-day FDA review.

K182417 · Medtech S.A · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2019
Decision
155d
Days
Class 2
Risk

K182417 is an FDA 510(k) clearance for the ROSA ONE Brain Application. Classified as Neurological Stereotaxic Instrument (product code HAW), Class II - Special Controls.

Submitted by Medtech S.A (Montpellier, FR). The FDA issued a Cleared decision on February 7, 2019 after a review of 155 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.4560 - the FDA neurology device 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 Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Medtech S.A devices

Submission Details

510(k) Number K182417 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 05, 2018
Decision Date February 07, 2019
Days to Decision 155 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
7d slower than avg
Panel avg: 148d · This submission: 155d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HAW Neurological Stereotaxic Instrument
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.4560
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 Neurology devices follow this clearance model.

Regulatory Peers - HAW Neurological Stereotaxic Instrument

All 217
Devices cleared under the same product code (HAW) and FDA review panel - the closest regulatory comparables to K182417.
StealthStation Synergy Cranial S7 Software v.2.2.8, StealthStation Cranial Software v3.1.1
K190672 · Medtronic Navigation, Inc. · Jul 2019
Modus Nav
K183325 · Synaptive Medical, Inc. · Jul 2019
Voyager Trajectory Array Guide (V-TAG)
K191400 · Mri Interventions, Inc. · Jun 2019
AQrate Robotic Assistance System
K182000 · Globus Medical, Inc. · Jan 2019
7D Surgical System Cranial Application
K181041 · 7D Surgical, Inc. · Aug 2018
neuromate Gen III
K181706 · Renishaw Mayfield Sarl · Jul 2018