Cleared Traditional

K040368 - VECTORVISION HIP 3.0

K040368 is an FDA 510(k) clearance for VECTORVISION HIP 3.0, manufactured by Brainlab AG. The device is a Class 2 Neurology device with product code HAW cleared through the Traditional 510(k) pathway after a 192-day FDA review.

K040368 · Brainlab AG · Neurology device
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Aug 2004
Decision
192d
Days
Class 2
Risk

K040368 is an FDA 510(k) clearance for the VECTORVISION HIP 3.0. 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 August 23, 2004 after a review of 192 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. 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.

View all Brainlab AG devices

FDA 510(k) Submission Details - K040368

510(k) Number K040368 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 13, 2004
Decision Date August 23, 2004
Days to Decision 192 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
44d slower than avg
Panel avg: 148d · This submission: 192d
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 334
Devices cleared under the same product code (HAW) and FDA review panel - the closest regulatory comparables to K040368.
NAVIGUS PASSIVE PROBE, MODEL NP-1000
K040334 · Image-Guided Neurologics, Inc. · Oct 2004
IPLAN! FLOW
K041330 · Brainlab AG · Sep 2004
SMITH & NEPHEW IMAGE GUIDED SURGICAL INSTRUMENTS FOR HIP APPLICATIONS
K033341 · Smith & Nephew, Inc. · Sep 2004
ELEKTA MICRODRIVE, MODEL 916716
K040979 · Elekta Instrument AB · Jul 2004
ACUMEN SURGICAL NAVIGATION SYSTEM
K031454 · Biomet, Inc. · Jul 2004
NAVITRACK SYSTEM - S&N IMAGE FREE HIP, MODEL PRO-03017
K041369 · Orthosoft, Inc. · Jun 2004