Cleared Special

K052623 - IMAGELESS HIP MODULE FOR THE STEALTHSTA...

K052623 is the FDA 510(k) clearance for IMAGELESS HIP MODULE FOR THE STEALTHSTA... by Medtronic Navigation, Inc.. It is a Class 2 Neurology device (product code HAW) cleared through the Special 510(k) pathway after a 160-day FDA review.

K052623 · Medtronic Navigation, Inc. · Neurology device
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Mar 2006
Decision
160d
Days
Class 2
Risk

K052623 is an FDA 510(k) clearance for the IMAGELESS HIP MODULE FOR THE STEALTHSTATION SYSTEM. Classified as Neurological Stereotaxic Instrument (product code HAW), Class II - Special Controls.

Submitted by Medtronic Navigation, Inc. (Louisville, US). The FDA issued a Cleared decision on March 2, 2006 after a review of 160 days - an extended review 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. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Medtronic Navigation, Inc. devices

Submission Details

510(k) Number K052623 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 23, 2005
Decision Date March 02, 2006
Days to Decision 160 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
12d slower than avg
Panel avg: 148d · This submission: 160d
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 K052623.
IPLAN FLOW
K053164 · Brainlab AG · Mar 2006
BIOMET PRE-CALIBRATED COMPUTER AIDED SURGERY NAVIGATION INSTRUMENTS FOR HIP APPLICATIONS
K060121 · Biomet Manufacturing Corp · Mar 2006
VECTORVISION HIP
K060468 · Brainlab AG · Mar 2006
CI KNEE, CI MI TKR
K052966 · Brainlab AG · Feb 2006
IPLAN
K053127 · Brainlab AG · Feb 2006
ZIMMER COMPUTER ASSISTED SOLUTIONS-ELECTROMAGNETIC AND IMAGELESS KNEE INSTRUMENTATION
K052425 · Zimmer, Inc. · Dec 2005