Cleared Traditional

K163182 - Medtronic Legend Pneumatic (FDA 510(k) Clearance)

Also includes:
MR7 Pneumatic Triton Pneumatic Drill System incorporating various Pneumatic Handpieces Attachments Surgical Dissecting Tools and System Accessories

Class II Neurology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K163182 · Medtronic Powered Surgical Solutions · Neurology device
Download Printable Device Report (PDF)
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Mar 2017
Decision
129d
Days
Class 2
Risk

K163182 is an FDA 510(k) clearance for the Medtronic Legend Pneumatic. Classified as Motor, Drill, Pneumatic (product code HBB), Class II - Special Controls.

Submitted by Medtronic Powered Surgical Solutions (Fort Worth, US). The FDA issued a Cleared decision on March 23, 2017 after a review of 129 days - within the typical 510(k) review window.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.4370 - 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 Medtronic Powered Surgical Solutions devices

Submission Details

510(k) Number K163182 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 14, 2016
Decision Date March 23, 2017
Days to Decision 129 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
19d faster than avg
Panel avg: 148d · This submission: 129d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HBB Motor, Drill, Pneumatic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.4370
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.