Cleared Traditional

K061248 - AXIEM IMAGELESS HIP MODULE FOR THE STEALTHSTATION SYSTEM

K061248 is an FDA 510(k) clearance for AXIEM IMAGELESS HIP MODULE FOR THE STEA..., manufactured by Medtronic Navigation, Inc.. The device is a Class 2 Neurology device with product code HAW cleared through the Traditional 510(k) pathway after a 120-day FDA review.

K061248 · Medtronic Navigation, Inc. · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2006
Decision
120d
Days
Class 2
Risk

K061248 is an FDA 510(k) clearance for the AXIEM 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 August 31, 2006 after a review of 120 days - within the typical 510(k) review window.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.4560 - the FDA neurology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K061248

510(k) Number K061248 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 03, 2006
Decision Date August 31, 2006
Days to Decision 120 days
Submission Type Traditional
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
29d faster than avg
Panel avg: 149d · This submission: 120d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K061248.
PIGALILEO TOTAL KNEE REPLACEMENT (TKR) SYSTEM
K061362 · Plus Orthopedics AG · Oct 2006
NAVIVISION
K062086 · Brainlab AG · Sep 2006
LAPDOC I
K061224 · Robodent GmbH · Sep 2006
VECTORVISION HIP
K060727 · Brainlab AG · Aug 2006
UNI KNEE SURGETICS NAVIGATION SYSTEM
K062146 · Praxim S.A · Aug 2006
STRYKER ORTHOPAEDICS RFID INSTRUMENTATION
K053348 · Howmedica Osteonics Corp. · Aug 2006
K061248 · AXIEM IMAGELESS HIP MODULE FOR THE STEALTHSTATION SYSTEM
Download PDF FDA Summary Medtronic Navigation,…