Cleared Special

K041369 - NAVITRACK SYSTEM - S&N IMAGE FREE HIP

K041369 is the FDA 510(k) clearance for NAVITRACK SYSTEM - S&N IMAGE FREE HIP by Orthosoft, Inc.. It is a Class 2 Neurology device (product code HAW) cleared through the Special 510(k) pathway after a 29-day FDA review.

K041369 · Orthosoft, Inc. · Neurology device
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Optimized for regulatory review, auditing and printing
Jun 2004
Decision
29d
Days
Class 2
Risk

K041369 is an FDA 510(k) clearance for the NAVITRACK SYSTEM - S&N IMAGE FREE HIP, MODEL PRO-03017. Classified as Neurological Stereotaxic Instrument (product code HAW), Class II - Special Controls.

Submitted by Orthosoft, Inc. (Montreal, CA). The FDA issued a Cleared decision on June 22, 2004 after a review of 29 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.4560 - 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 Orthosoft, Inc. devices

Submission Details

510(k) Number K041369 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 24, 2004
Decision Date June 22, 2004
Days to Decision 29 days
Submission Type Special
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
119d faster than avg
Panel avg: 148d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

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 K041369.
VECTORVISION HIP 3.0
K040368 · Brainlab AG · Aug 2004
ELEKTA MICRODRIVE, MODEL 916716
K040979 · Elekta Instrument AB · Jul 2004
ACUMEN SURGICAL NAVIGATION SYSTEM
K031454 · Biomet, Inc. · Jul 2004
ZIMMER ORTHO GUIDANCE SYSTEMS- HIP INSTRUMENTS
K033223 · Zimmer, Inc. · Feb 2004
VECTORVISION CRANIAL/ENT
K023651 · Brainlab AG · Feb 2004
ZIMMER ORTHO GUIDANCE SYSTEMS- KNEE INSTRUMENTS
K033011 · Zimmer, Inc. · Feb 2004