Cleared Traditional

K050651 - MEDTRONIC ORTHOPAEDIC TRAUMA APPLICATION

K050651 is an FDA 510(k) clearance for MEDTRONIC ORTHOPAEDIC TRAUMA APPLICATION, manufactured by Medtronic Navigation, Inc.. The device is a Class 2 Neurology device with 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

FDA 510(k) Submission Details - K050651

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.

HAW Device Classification - Class 2, Special Controls

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 331
Devices cleared under the same product code (HAW) and FDA review panel - the closest regulatory comparables to K050651.
VOYAGER LINUX WITH TACTILE GUIDANCE SYSTEM (TGS)
K052851 · Mako Surgical Corp. · Nov 2005
NAVIGATION SW HIP 3.1 ON CI
K052213 · Brainlab AG · Nov 2005
DEPUY CAS HIP INSTRUMENTATION
K052178 · DePuy Orthopaedics, Inc. · Oct 2005
ELEKTA ESARTE FRAME SYSTEM
K051746 · Elekta Instrument AB · Jul 2005
ACUMEN IMAGE GUIDED SURGICAL SYSTEM
K051724 · Ebi, L.P. · Jul 2005
STELTHSTATION WIRELESS SURGEON MOUSE
K051029 · Medtronic Surgical Navigation · Jun 2005