Cleared Special

K043536 - NAVITRACK SYSTEM - S&N IMAGE FREE KNEE

K043536 is an FDA 510(k) clearance for NAVITRACK SYSTEM - S&N IMAGE FREE KNEE, manufactured by Orthosoft, Inc.. The device is a Class 2 Neurology device with product code HAW cleared through the Special 510(k) pathway after a 23-day FDA review.

K043536 · Orthosoft, Inc. · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2005
Decision
23d
Days
Class 2
Risk

K043536 is an FDA 510(k) clearance for the NAVITRACK SYSTEM - S&N IMAGE FREE KNEE. 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 January 14, 2005 after a review of 23 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.

FDA 510(k) Submission Details - K043536

510(k) Number K043536 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 22, 2004
Decision Date January 14, 2005
Days to Decision 23 days
Submission Type Special
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
126d faster than avg
Panel avg: 149d · This submission: 23d
Pathway characteristics
Modification to existing cleared device.

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 426
Devices cleared under the same product code (HAW) and FDA review panel - the closest regulatory comparables to K043536.
DEPUY CAS KNEE INSTRUMENTATION
K043223 · DePuy Orthopaedics, Inc. · Mar 2005
VECTORVISION OSTEOTOMY
K042513 · Brainlab AG · Feb 2005
NAVIGUS NEXDRIVE, MODEL MI-3000
K043091 · Image-Guided Neurologics, Inc. · Feb 2005
VECTORVISION ACL
K042512 · Brainlab AG · Jan 2005
MEDTRONIC SNT STEALTHSTATION AXIEM IMAGELESS KNEE MODULE
K043088 · Medtronic Surgical Navigation Technologies · Jan 2005
PATHFINDER
K041477 · Armstrong Healthcare Limited · Dec 2004
K043536 · NAVITRACK SYSTEM - S&N IMAGE FREE KNEE
Download PDF FDA Summary Orthosoft, Inc.