Cleared Traditional

NAVIPRO KNEE SOFTWARE MODULE (K033668) - FDA 510(k) Clearance

Class II Neurology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K033668 · Kinamed, Inc. · Neurology device
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Optimized for regulatory review, auditing and printing
Mar 2004
Decision
111d
Days
Class 2
Risk

K033668 is an FDA 510(k) clearance for the NAVIPRO KNEE SOFTWARE MODULE. Classified as Neurological Stereotaxic Instrument (product code HAW), Class II - Special Controls.

Submitted by Kinamed, Inc. (Camarillo, US). The FDA issued a Cleared decision on March 11, 2004 after a review of 111 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 Kinamed, Inc. devices

Submission Details

510(k) Number K033668 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 21, 2003
Decision Date March 11, 2004
Days to Decision 111 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
37d faster than avg
Panel avg: 148d · This submission: 111d
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 105
Devices cleared under the same product code (HAW) and FDA review panel - the closest regulatory comparables to K033668.
DEPUY CAS KNEE INSTRUMENTATION
K043223 · DePuy Orthopaedics, Inc. · Mar 2005
SMITH & NEPHEW IMAGE GUIDED SURGICAL INSTRUMENTS FOR HIP APPLICATIONS
K033341 · Smith & Nephew, Inc. · Sep 2004
ACUMEN SURGICAL NAVIGATION SYSTEM
K031454 · Biomet, Inc. · Jul 2004
ZIMMER ORTHO GUIDANCE SYSTEMS- HIP INSTRUMENTS
K033223 · Zimmer, Inc. · Feb 2004
ZIMMER ORTHO GUIDANCE SYSTEMS- KNEE INSTRUMENTS
K033011 · Zimmer, Inc. · Feb 2004
ACUMEN SURGICAL NAVIGATION SYSTEM
K031337 · Biomet, Inc. · Sep 2003