Cleared Traditional

K111558 - SURGICASE GUIDE

K111558 is the FDA 510(k) clearance for SURGICASE GUIDE by Materialise NV. It is a Class 2 Neurology device (product code HAW) cleared through the Traditional 510(k) pathway after a 298-day FDA review.

K111558 · Materialise NV · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2012
Decision
298d
Days
Class 2
Risk

K111558 is an FDA 510(k) clearance for the SURGICASE GUIDE. Classified as Neurological Stereotaxic Instrument (product code HAW), Class II - Special Controls.

Submitted by Materialise NV (Leuven, BE). The FDA issued a Cleared decision on March 27, 2012 after a review of 298 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 Materialise NV devices

Submission Details

510(k) Number K111558 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 03, 2011
Decision Date March 27, 2012
Days to Decision 298 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
150d slower than avg
Panel avg: 148d · This submission: 298d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K111558.
QUADCUT
K130608 · Medtronic Navigation, Inc. · Aug 2013
SYNTHES NAVIGABLE PEDICLE PREPARATION INSTRUMENTS
K122211 · Synthes Spine · Dec 2012
KARL STORZ NAVIGATIONPANEL UNIT (NPU) SYSTEM
K122096 · KARL STORZ Endoscopy-America, Inc. · Sep 2012
IPLAN
K101627 · Brainlab AG · Jun 2011
DISPOSABLE REFLECTIVE MARKER SPHERES
K100038 · Brainlab AG · Jul 2010
VECTORVISION CRANIAL, VECTORVISION ENT, KOLIBRI CRANIAL, KOLIBRI ENT, CRANIAL ESSENTIAL, CRANIAL UNLIMITED
K092467 · Brainlab AG · May 2010