Cleared Special

K033341 - SMITH & NEPHEW IMAGE GUIDED SURGICAL INSTRUMENTS FOR HIP APPLICATIONS

K033341 is an FDA 510(k) clearance for SMITH & NEPHEW IMAGE GUIDED SURGICAL IN..., 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 329-day FDA review.

K033341 · Smith & Nephew, Inc. · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2004
Decision
329d
Days
Class 2
Risk

K033341 is an FDA 510(k) clearance for the SMITH & NEPHEW IMAGE GUIDED SURGICAL INSTRUMENTS FOR HIP 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 September 10, 2004 after a review of 329 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. 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. Elevated predicate reliance 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 - K033341

510(k) Number K033341 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 17, 2003
Decision Date September 10, 2004
Days to Decision 329 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
180d slower than avg
Panel avg: 149d · This submission: 329d
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 K033341.
VECTORVISION UNI-KNEE
K041899 · Brainlab AG · Oct 2004
NAVIGUS PASSIVE PROBE, MODEL NP-1000
K040334 · Image-Guided Neurologics, Inc. · Oct 2004
IPLAN! FLOW
K041330 · Brainlab AG · Sep 2004
VECTORVISION HIP 3.0
K040368 · Brainlab AG · Aug 2004
ELEKTA MICRODRIVE, MODEL 916716
K040979 · Elekta Instrument AB · Jul 2004
ACUMEN SURGICAL NAVIGATION SYSTEM
K031454 · Biomet, Inc. · Jul 2004
K033341 · SMITH & NEPHEW IMAGE GUIDED SURGICAL INSTRUMENTS FOR HIP APPLICATIONS
Download PDF FDA Summary Smith & Nephew, Inc.