Cleared Special

K004027 - STRYKER REMOTE SURGICAL PLANNING SYSTEM

K004027 is the FDA 510(k) clearance for STRYKER REMOTE SURGICAL PLANNING SYSTEM by Stryker Instruments. It is a Class 2 Neurology device (product code HAW) cleared through the Special 510(k) pathway after a 28-day FDA review.

K004027 · Stryker Instruments · Neurology device
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Jan 2001
Decision
28d
Days
Class 2
Risk

K004027 is an FDA 510(k) clearance for the STRYKER REMOTE SURGICAL PLANNING SYSTEM. Classified as Neurological Stereotaxic Instrument (product code HAW), Class II - Special Controls.

Submitted by Stryker Instruments (Kalamazoo, US). The FDA issued a Cleared decision on January 24, 2001 after a review of 28 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.

View all Stryker Instruments devices

Submission Details

510(k) Number K004027 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 27, 2000
Decision Date January 24, 2001
Days to Decision 28 days
Submission Type Special
Review Panel Neurology (NE)
Summary Statement
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: 148d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

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 K004027.
STEREOTACTIC FRAME BASED SYSTEM
K003486 · Stryker Instruments · May 2001
LORENZ FIDUCAIL SCREW
K010427 · Walter Lorenz Surgical, Inc. · Mar 2001
Z-TOUCH
K003268 · Brainlab AG · Feb 2001
STRYKER NAVIGATION SYSTEM-SPINE & FLUOROSCOPY MODULES
K003111 · Stryker Instruments · Jan 2001
STRYKER NAVIGATION SYSTEM - ENT MODULE
K002732 · Stryker Corp. · Oct 2000
OPTICAL TRACKING SYSTEM (OTS)
K001950 · Radionics, Inc. · Jul 2000