Cleared Traditional

K012937 - KNEE MODULE FOR THE STEALTHSTATION SYSTEM

K012937 is the FDA 510(k) clearance for KNEE MODULE FOR THE STEALTHSTATION SYSTEM by Medtronic Surgical Navigation Technologies. It is a Class 2 Neurology device (product code HAW) cleared through the Traditional 510(k) pathway after a 147-day FDA review.

K012937 · Medtronic Surgical Navigation Technologies · Neurology device
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Jan 2002
Decision
147d
Days
Class 2
Risk

K012937 is an FDA 510(k) clearance for the KNEE MODULE FOR THE STEALTHSTATION SYSTEM. Classified as Neurological Stereotaxic Instrument (product code HAW), Class II - Special Controls.

Submitted by Medtronic Surgical Navigation Technologies (Louisville, US). The FDA issued a Cleared decision on January 25, 2002 after a review of 147 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 Surgical Navigation Technologies devices

Submission Details

510(k) Number K012937 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 31, 2001
Decision Date January 25, 2002
Days to Decision 147 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
1d faster than avg
Panel avg: 148d · This submission: 147d
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 218
Devices cleared under the same product code (HAW) and FDA review panel - the closest regulatory comparables to K012937.
ORTHOPILOT 2
K013569 · Aesculap, Inc. · Apr 2002
VECTORVISION TRAUMA
K012448 · Brainlab AG · Mar 2002
SMITH & NEPHEW IMAGE GUIDED SURGICAL INSTRUMENTS FOR KNEE APPLICATIONS
K012938 · Smith & Nephew, Inc. · Feb 2002
MODIFICATION TO LEKSELL SURGIPLAN WITH ATLASPACE
K013861 · Elekta Instrument AB · Dec 2001
HEMI-ARC SURGICAL NAVIGATOR
K013257 · Nuvasive, Inc. · Oct 2001
VECTORVISION HIP
K010602 · Brainlab AG · Sep 2001