Cleared Special

K052623 - IMAGELESS HIP MODULE FOR THE STEALTHSTATION SYSTEM

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

K052623 · Medtronic Navigation, Inc. · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

FDA 510(k) Submission Details - K052623

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
11d slower than avg
Panel avg: 149d · This submission: 160d
Pathway characteristics
Modification to existing cleared device.

HAW Device Classification - Class 2, Special Controls

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 426
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
K052623 · IMAGELESS HIP MODULE FOR THE STEALTHSTATION SYSTEM
Download PDF FDA Summary Medtronic Navigation,…