Cleared Special

K213454 - Midas Rex MR8 Depth Stop Attachment

K213454 is an FDA 510(k) clearance for Midas Rex MR8 Depth Stop Attachment, 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 28-day FDA review.

K213454 · Medtronic Powered Surgical Solutions · Neurology device
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Nov 2021
Decision
28d
Days
Class 2
Risk

K213454 is an FDA 510(k) clearance for the Midas Rex MR8 Depth Stop Attachment, Midas Rex MR8 Depth Stop Tool 2.4mm, Mid.... 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 November 23, 2021 after a review of 28 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 - K213454

510(k) Number K213454 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 26, 2021
Decision Date November 23, 2021
Days to Decision 28 days
Submission Type Special
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
120d faster than avg
Panel avg: 148d · This submission: 28d
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 41
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