Cleared Traditional

K022579 - STRYKER NAVIGATION SYSTEM-KNEE MODULE

K022579 is an FDA 510(k) clearance for STRYKER NAVIGATION SYSTEM-KNEE MODULE, manufactured by Stryker Leibinger. The device is a Class 2 Neurology device with product code HAW cleared through the Traditional 510(k) pathway after a 301-day FDA review.

K022579 · Stryker Leibinger · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2003
Decision
301d
Days
Class 2
Risk

K022579 is an FDA 510(k) clearance for the STRYKER NAVIGATION SYSTEM-KNEE MODULE. 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 June 2, 2003 after a review of 301 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K022579

510(k) Number K022579 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 05, 2002
Decision Date June 02, 2003
Days to Decision 301 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
152d slower than avg
Panel avg: 149d · This submission: 301d
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 418
Devices cleared under the same product code (HAW) and FDA review panel - the closest regulatory comparables to K022579.
MODIFICATION TO LEKSELL STEREOTACTIC SYSTEM
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IGI-SYSTEM
K023424 · Denx Advanced Dental Systems · May 2003
NAVITRACK SYSTEM-FLUOROSPINE, MODEL 900.005
K031156 · Orthosoft, Inc. · May 2003
K022579 · STRYKER NAVIGATION SYSTEM-KNEE MODULE
Download PDF FDA Summary Stryker Leibinger