Cleared Traditional

K050651 - MEDTRONIC ORTHOPAEDIC TRAUMA APPLICATION

K050651 is the FDA 510(k) clearance for MEDTRONIC ORTHOPAEDIC TRAUMA APPLICATION by Medtronic Navigation, Inc.. It is a Class 2 Neurology device (product code HAW) cleared through the Traditional 510(k) pathway after a 135-day FDA review.

K050651 · Medtronic Navigation, Inc. · Neurology device
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Jul 2005
Decision
135d
Days
Class 2
Risk

K050651 is an FDA 510(k) clearance for the MEDTRONIC ORTHOPAEDIC TRAUMA APPLICATION. Classified as Neurological Stereotaxic Instrument (product code HAW), Class II - Special Controls.

Submitted by Medtronic Navigation, Inc. (Louisville, US). The FDA issued a Cleared decision on July 27, 2005 after a review of 135 days - within the typical 510(k) review window.

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 Medtronic Navigation, Inc. devices

Submission Details

510(k) Number K050651 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 14, 2005
Decision Date July 27, 2005
Days to Decision 135 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
13d faster than avg
Panel avg: 148d · This submission: 135d
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 K050651.
ZIMMER COMPUTER ASSISTED SOLUTIONS-ELECTROMAGNETIC AND IMAGELESS KNEE INSTRUMENTATION
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DEPUY CAS HIP INSTRUMENTATION
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ELEKTA ESARTE FRAME SYSTEM
K051746 · Elekta Instrument AB · Jul 2005
ACUMEN IMAGE GUIDED SURGICAL SYSTEM
K051724 · Ebi, L.P. · Jul 2005
IPLAN! DIGITAL TEMPLATING
K042543 · Brainlab AG · May 2005