Cleared Special

K022460 - SMITH & NEPHEW IMAGE GUIDED SURGICAL SYSTEM FOR KNEE APPLICATIONS

K022460 is an FDA 510(k) clearance for SMITH & NEPHEW IMAGE GUIDED SURGICAL SY..., manufactured by Smith & Nephew, Inc.. The device is a Class 2 Neurology device with product code HAW cleared through the Special 510(k) pathway after a 24-day FDA review.

K022460 · Smith & Nephew, Inc. · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2002
Decision
24d
Days
Class 2
Risk

K022460 is an FDA 510(k) clearance for the SMITH & NEPHEW IMAGE GUIDED SURGICAL SYSTEM FOR KNEE APPLICATIONS. Classified as Neurological Stereotaxic Instrument (product code HAW), Class II - Special Controls.

Submitted by Smith & Nephew, Inc. (Memphis, US). The FDA issued a Cleared decision on August 19, 2002 after a review of 24 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.

FDA 510(k) Submission Details - K022460

510(k) Number K022460 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 26, 2002
Decision Date August 19, 2002
Days to Decision 24 days
Submission Type Special
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
125d faster than avg
Panel avg: 149d · This submission: 24d
Pathway characteristics
Modification to existing cleared device.

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 426
Devices cleared under the same product code (HAW) and FDA review panel - the closest regulatory comparables to K022460.
NAVIGUS MANUAL DISPOSABLE MICRODRIVE WITH DIGITAL DISPLAY, MODELS MI-1000 & MI-1010
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IPLAN
K020631 · Brainlab AG · Sep 2002
NAVITRACK SYSTEM-OPTICAL TKR CT-LESS, MODEL 900.120
K021760 · Orthosoft, Inc. · Aug 2002
STEALTHSTATION SYSTEM THREE DIMENSIONAL C-ARM INTERFACE
K022414 · Medtronic Surgical Navigation Technologies · Aug 2002
SPHERZ
K022074 · I.Z.I. Corp. · Aug 2002
ALPHA DRIVE SYSTEM
K013396 · Alpha Omega , Ltd. · Aug 2002
K022460 · SMITH & NEPHEW IMAGE GUIDED SURGICAL SYSTEM FOR KNEE APPLICATIONS
Download PDF FDA Summary Smith & Nephew, Inc.