Cleared Special

K052851 - VOYAGER LINUX WITH TACTILE GUIDANCE SYS...

K052851 is the FDA 510(k) clearance for VOYAGER LINUX WITH TACTILE GUIDANCE SYS... by Mako Surgical Corp.. It is a Class 2 Neurology device (product code HAW) cleared through the Special 510(k) pathway after a 38-day FDA review.

K052851 · Mako Surgical Corp. · Neurology device
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Nov 2005
Decision
38d
Days
Class 2
Risk

K052851 is an FDA 510(k) clearance for the VOYAGER LINUX WITH TACTILE GUIDANCE SYSTEM (TGS). Classified as Neurological Stereotaxic Instrument (product code HAW), Class II - Special Controls.

Submitted by Mako Surgical Corp. (Hollywood, US). The FDA issued a Cleared decision on November 18, 2005 after a review of 38 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 Mako Surgical Corp. devices

Submission Details

510(k) Number K052851 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 11, 2005
Decision Date November 18, 2005
Days to Decision 38 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
110d faster than avg
Panel avg: 148d · This submission: 38d
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 218
Devices cleared under the same product code (HAW) and FDA review panel - the closest regulatory comparables to K052851.
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