Cleared Traditional

K981315 - NAVITRACK

K981315 is an FDA 510(k) clearance for NAVITRACK, manufactured by Orthosoft, Inc.. The device is a Class 2 Neurology device with product code HAW cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K981315 · Orthosoft, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1998
Decision
90d
Days
Class 2
Risk

K981315 is an FDA 510(k) clearance for the NAVITRACK. Classified as Neurological Stereotaxic Instrument (product code HAW), Class II - Special Controls.

Submitted by Orthosoft, Inc. (Outremont, Quebec, CA). The FDA issued a Cleared decision on July 9, 1998 after a review of 90 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 Orthosoft, Inc. devices

FDA 510(k) Submission Details - K981315

510(k) Number K981315 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 10, 1998
Decision Date July 09, 1998
Days to Decision 90 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
58d faster than avg
Panel avg: 148d · This submission: 90d
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 333
Devices cleared under the same product code (HAW) and FDA review panel - the closest regulatory comparables to K981315.
STEALTHSTATION SYSTEM DIGITIZER CHANGE
K981686 · Surgical Navigation Technologies, Inc. · Aug 1998
STEALTHSTATION TREATMENT GUIDANCE PLATFORM
K981684 · Surgical Navigation Technologies, Inc. · Aug 1998
WIRELESS STANDARD PROBE, DYNAMIC REFERENCE FRAME (DRF)
K982364 · Radionics, Inc. · Aug 1998
UNIVERSAL INSTRUMENT REGISTRATION (UIR) MICROSCOPE MODULE I
K981213 · Radionics, Inc. · Jul 1998
ATLASPLAN
K980584 · Radionics, Inc. · May 1998
OPTICAL TRACKING SYSTEM (OTS)
K974602 · Radionics Software Applications, Inc. · Apr 1998