Cleared Special

K072573 - VECTORVISION HIP AND HIP SR

K072573 is an FDA 510(k) clearance for VECTORVISION HIP AND HIP SR, manufactured by Brainlab AG. The device is a Class 2 Neurology device with product code HAW cleared through the Special 510(k) pathway after a 29-day FDA review.

K072573 · Brainlab AG · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2007
Decision
29d
Days
Class 2
Risk

K072573 is an FDA 510(k) clearance for the VECTORVISION HIP AND HIP SR. Classified as Neurological Stereotaxic Instrument (product code HAW), Class II - Special Controls.

Submitted by Brainlab AG (Feldkirchen, DE). The FDA issued a Cleared decision on October 11, 2007 after a review of 29 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.

FDA 510(k) Submission Details - K072573

510(k) Number K072573 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 12, 2007
Decision Date October 11, 2007
Days to Decision 29 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
120d faster than avg
Panel avg: 149d · This submission: 29d
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 K072573.
STRYKER NAVIGATION SYSTEM INFINITUS HIP RESURFACING MODULE
K072271 · Stryker Corp. · Dec 2007
TOTAL HIP SURGETICS NAVIGATION SYSTEM
K072267 · Praxim S.A · Dec 2007
VECTOR VISION HIP
K072716 · Brainlab AG · Oct 2007
BRAINSUITE NET
K070556 · Brainlab AG · Sep 2007
NAVITRACK SYSTEM- PARTIAL HIP RESURFACING UNIVERSAL
K071929 · Orthosoft, Inc. · Sep 2007
SPINEASSIST SYSTEM
K063607 · Mazor Surgical Technologies , Ltd. · Aug 2007
K072573 · VECTORVISION HIP AND HIP SR
Download PDF FDA Summary Brainlab AG