Cleared Traditional

K022364 - NAVITRACK SYSTEM TOTAL HIP REPLACEMENT

K022364 is the FDA 510(k) clearance for NAVITRACK SYSTEM TOTAL HIP REPLACEMENT by Orthosoft, Inc.. It is a Class 2 Neurology device (product code HAW) cleared through the Traditional 510(k) pathway after a 197-day FDA review.

K022364 · Orthosoft, Inc. · Neurology device
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Feb 2003
Decision
197d
Days
Class 2
Risk

K022364 is an FDA 510(k) clearance for the NAVITRACK SYSTEM TOTAL HIP REPLACEMENT,MODEL 900.200. 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 February 4, 2003 after a review of 197 days - an extended review cycle.

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 Orthosoft, Inc. devices

Submission Details

510(k) Number K022364 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 22, 2002
Decision Date February 04, 2003
Days to Decision 197 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
49d slower than avg
Panel avg: 148d · This submission: 197d
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 K022364.
MODIFICATION TO LEKSELL STEREOTACTIC SYSTEM
K031980 · Elekta Instrument AB · Jul 2003
ELEKTA LEKSELL STEREOTACTIC SYSTEM WITH MR POST KIT
K031999 · Elekta Instrument AB · Jul 2003
VECTORVISION FLUORO3D
K024192 · Brainlab AG · Jun 2003
STRYKER NAVIGATION SYSTEM - HIP MODULE
K022365 · Stryker Instruments · Jan 2003
SMITH & NEPHEW IMAGE GUIDED SURGICAL INSTRUMENTS FOR HIP APPLICATIONS
K021798 · Smith & Nephew, Inc. · Dec 2002
VECTORVISION CT-FREE KNEE
K021306 · Brainlab AG · Oct 2002