Cleared Special

K022460 - SMITH & NEPHEW IMAGE GUIDED SURGICAL SY...

K022460 is the FDA 510(k) clearance for SMITH & NEPHEW IMAGE GUIDED SURGICAL SY... by Smith & Nephew, Inc.. It is a Class 2 Neurology device (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)
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.

View all Smith & Nephew, Inc. devices

Submission Details

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
124d faster than avg
Panel avg: 148d · This submission: 24d
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 225
Devices cleared under the same product code (HAW) and FDA review panel - the closest regulatory comparables to K022460.
VECTORVISION CT-FREE KNEE
K021306 · Brainlab AG · Oct 2002
SMITH & NEPHEW IMAGE SURGICAL INSTRUMENTS FOR TRAUMA APPLICATIONS
K021815 · Smith & Nephew, Inc. · Oct 2002
IPLAN
K020631 · Brainlab AG · Sep 2002
ORTHOPILOT HTO MODULE
K021327 · Aesculap, Inc. · Jul 2002
KOLIBRI IGS SYSTEMS
K014256 · Brainlab AG · Jul 2002
ENDOMAP
K014113 · Siemens Medical Solutions USA, Inc. · Jun 2002