Cleared Special

K182436 - POWEREASE System (FDA 510(k) Clearance)

Class II Neurology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K182436 · Medtronic Sofamor Danek USA, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2018
Decision
27d
Days
Class 2
Risk

K182436 is an FDA 510(k) clearance for the POWEREASE System. Classified as Drills, Burrs, Trephines & Accessories (simple, Powered) (product code HBE), Class II - Special Controls.

Submitted by Medtronic Sofamor Danek USA, Inc. (Memphis, US). The FDA issued a Cleared decision on October 4, 2018 after a review of 27 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.4310 - the FDA neurology device 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 Medtronic Sofamor Danek USA, Inc. devices

Submission Details

510(k) Number K182436 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 07, 2018
Decision Date October 04, 2018
Days to Decision 27 days
Submission Type Special
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
121d faster than avg
Panel avg: 148d · This submission: 27d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code HBE Drills, Burrs, Trephines & Accessories (simple, Powered)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.4310
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 - HBE Drills, Burrs, Trephines & Accessories (simple, Powered)

All 64
Devices cleared under the same product code (HBE) and FDA review panel - the closest regulatory comparables to K182436.
Surgify Halo (54.085.SHD.U1)
K253627 · Surgify Medical OY · Mar 2026
Hubly Drill (H100)
K250815 · Hubly, Inc. · Nov 2025
GREEN
K252060 · Phasor Health, LLC · Oct 2025
UniBur
K252662 · Nakanishi, Inc. · Sep 2025
Surgify Halo (54.085.SHD.H1)
K251433 · Surgify Medical OY · Jun 2025
Surgify Halo (54.085.SHD.H1)
K250380 · Surgify Medical OY · Mar 2025