Cleared Special

K060468 - VECTORVISION HIP

K060468 is the FDA 510(k) clearance for VECTORVISION HIP by Brainlab AG. It is a Class 2 Neurology device (product code HAW) cleared through the Special 510(k) pathway after a 25-day FDA review.

K060468 · Brainlab AG · Neurology device
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Mar 2006
Decision
25d
Days
Class 2
Risk

K060468 is an FDA 510(k) clearance for the VECTORVISION HIP. Classified as Neurological Stereotaxic Instrument (product code HAW), Class II - Special Controls.

Submitted by Brainlab AG (Heimstetten, DE). The FDA issued a Cleared decision on March 20, 2006 after a review of 25 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 Brainlab AG devices

Submission Details

510(k) Number K060468 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 23, 2006
Decision Date March 20, 2006
Days to Decision 25 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
123d faster than avg
Panel avg: 148d · This submission: 25d
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 217
Devices cleared under the same product code (HAW) and FDA review panel - the closest regulatory comparables to K060468.
VECTORVISION SPINE
K053159 · Brainlab AG · Jun 2006
IPLAN FLOW
K053164 · Brainlab AG · Mar 2006
BIOMET PRE-CALIBRATED COMPUTER AIDED SURGERY NAVIGATION INSTRUMENTS FOR HIP APPLICATIONS
K060121 · Biomet Manufacturing Corp · Mar 2006
IMAGELESS HIP MODULE FOR THE STEALTHSTATION SYSTEM
K052623 · Medtronic Navigation, Inc. · Mar 2006
CI KNEE, CI MI TKR
K052966 · Brainlab AG · Feb 2006
IPLAN
K053127 · Brainlab AG · Feb 2006