Cleared Traditional

K991706 - VIRTUOSO-STEREOTAXIC PLANNING SOFTWARE

K991706 is an FDA 510(k) clearance for VIRTUOSO-STEREOTAXIC PLANNING SOFTWARE, manufactured by Stryker Corp.. The device is a Class 2 Neurology device with product code HAW cleared through the Traditional 510(k) pathway after a 202-day FDA review.

K991706 · Stryker Corp. · Neurology device
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Dec 1999
Decision
202d
Days
Class 2
Risk

K991706 is an FDA 510(k) clearance for the VIRTUOSO-STEREOTAXIC PLANNING SOFTWARE. Classified as Neurological Stereotaxic Instrument (product code HAW), Class II - Special Controls.

Submitted by Stryker Corp. (Kalamazoo, US). The FDA issued a Cleared decision on December 7, 1999 after a review of 202 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 Stryker Corp. devices

FDA 510(k) Submission Details - K991706

510(k) Number K991706 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 19, 1999
Decision Date December 07, 1999
Days to Decision 202 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
54d slower than avg
Panel avg: 148d · This submission: 202d
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 341
Devices cleared under the same product code (HAW) and FDA review panel - the closest regulatory comparables to K991706.
BRAINLAB STEREOTACTIC ARC
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3D1 MICROPOSITIONING HEADSTAGE
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AXON MP-1 MICROPOSITIONER
K990683 · Axon Instruments, Inc. · Nov 1999
THE MAYFIELD / ACCISS SYSTEM WITH WINDOWS NT FOR CRANIAL SURGERY, THE MAYFIELD / OPTICAL ACCISS SYSTEM WITH WINDOWS NT F
K992843 · Ohio Medical Instrument Co., Inc. · Nov 1999