Cleared Special

IMNS MEDACTA NAVIGATION SYSTEM,33.221000US (K100314) - FDA 510(k) Clearance

Class II Neurology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K100314 · Medacta International S.A. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2010
Decision
55d
Days
Class 2
Risk

K100314 is an FDA 510(k) clearance for the IMNS MEDACTA NAVIGATION SYSTEM,33.221000US. Classified as Neurological Stereotaxic Instrument (product code HAW), Class II - Special Controls.

Submitted by Medacta International S.A. (Camarillo, US). The FDA issued a Cleared decision on March 31, 2010 after a review of 55 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 Medacta International S.A. devices

Submission Details

510(k) Number K100314 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 04, 2010
Decision Date March 31, 2010
Days to Decision 55 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
93d faster than avg
Panel avg: 148d · This submission: 55d
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 103
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