Cleared Traditional

MODIFICATION TO: STRYKER NAVIGATION SYSTEM, STRYKER FLUOROSCOPY SYSTEM,VIRTUAL FLUOROSCOPY (K012380) - FDA 510(k) Clearance

Class II Neurology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K012380 · Stryker Leibinger · Neurology device
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Dec 2001
Decision
130d
Days
Class 2
Risk

K012380 is an FDA 510(k) clearance for the MODIFICATION TO: STRYKER NAVIGATION SYSTEM, STRYKER FLUOROSCOPY SYSTEM,VIRTUA.... Classified as Neurological Stereotaxic Instrument (product code HAW), Class II - Special Controls.

Submitted by Stryker Leibinger (Kalamazoo, US). The FDA issued a Cleared decision on December 3, 2001 after a review of 130 days - within the typical 510(k) review window.

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 Leibinger devices

Submission Details

510(k) Number K012380 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 26, 2001
Decision Date December 03, 2001
Days to Decision 130 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
18d faster than avg
Panel avg: 148d · This submission: 130d
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 104
Devices cleared under the same product code (HAW) and FDA review panel - the closest regulatory comparables to K012380.
ENDOMAP
K014113 · Siemens Medical Solutions USA, Inc. · Jun 2002
ORTHOPILOT 2
K013569 · Aesculap, Inc. · Apr 2002
SMITH & NEPHEW IMAGE GUIDED SURGICAL INSTRUMENTS FOR KNEE APPLICATIONS
K012938 · Smith & Nephew, Inc. · Feb 2002
VOYAGER 6.0 SOFTWARE OPTION
K000310 · Philips Medical Systems (Cleveland), Inc. · Feb 2000
VIEWPOINT ENT/ORTHOPEDIC OPTION
K991256 · Philips Medical Systems (Cleveland), Inc. · Oct 1999
VIEWPOINT TOOLS- STERRAD
K983764 · Philips Medical Systems (Cleveland), Inc. · Jul 1999