Cleared Special

K072315 - MIDAS REX CURVED BUR

K072315 is an FDA 510(k) clearance for MIDAS REX CURVED BUR, manufactured by Medtronic Powered Surgical Solutions. The device is a Class 2 Neurology device with product code HBE cleared through the Special 510(k) pathway after a 29-day FDA review.

K072315 · Medtronic Powered Surgical Solutions · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2007
Decision
29d
Days
Class 2
Risk

K072315 is an FDA 510(k) clearance for the MIDAS REX CURVED BUR. Classified as Drills, Burrs, Trephines & Accessories (simple, Powered) (product code HBE), Class II - Special Controls.

Submitted by Medtronic Powered Surgical Solutions (Fort Worth, US). The FDA issued a Cleared decision on September 18, 2007 after a review of 29 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 Powered Surgical Solutions devices

FDA 510(k) Submission Details - K072315

510(k) Number K072315 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 20, 2007
Decision Date September 18, 2007
Days to Decision 29 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
119d faster than avg
Panel avg: 148d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

HBE Device Classification - Class 2, Special Controls

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 42
Devices cleared under the same product code (HBE) and FDA review panel - the closest regulatory comparables to K072315.
IPC POWEREASE SYSTEM
K111520 · Medtronic Xomed, Inc. · Oct 2011
ELECTRIC DRILL SYSTEM [XPS 4000 SYSTEM, MIDAS REX LEGEND EHS SYSTEM, INTEGRATED POWER CONSOLE (IPC)]
K081475 · Medtronic Xomed, Inc. · Oct 2008
EMAX 2 PLUS SYSTEM, MODEL EMAX 2 PLUS MOTOR, EMAX 2 CONSOLE>FIRMWARE UPGRADE, EMAX 2 FP FOOT PEDAL
K080802 · The Anspach Effort, Inc. · Apr 2008
TWIST DRILL
K062842 · Walter Lorenz Surgical, Inc. · Dec 2006
ANSPACH COUPLER
K050628 · The Anspach Effort, Inc. · Apr 2005
ANSPACH MINIMAL ACCESS SPINAL ATTACHMENT (MASA) SYSTEM
K042783 · The Anspach Effort, Inc. · Dec 2004