Cleared Special

K033669 - SMITH & NEPHEW LOCKING BONE PLATE SYSTEM (LOCKING BONE PLATES AND SCREWS)

K033669 is an FDA 510(k) clearance for SMITH & NEPHEW LOCKING BONE PLATE SYSTE..., manufactured by Smith & Nephew, Inc.. The device is a Class 2 Orthopedic device with product code HRS cleared through the Special 510(k) pathway after a 19-day FDA review.

K033669 · Smith & Nephew, Inc. · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2003
Decision
19d
Days
Class 2
Risk

K033669 is an FDA 510(k) clearance for the SMITH & NEPHEW LOCKING BONE PLATE SYSTEM (LOCKING BONE PLATES AND SCREWS). Classified as Plate, Fixation, Bone within the HRS classification (a category comprising bone fixation plates and orthopedic hardware), Class II - Special Controls.

Submitted by Smith & Nephew, Inc. (Cordova, US). The FDA issued a Cleared decision on December 10, 2003 after a review of 19 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3030 - the FDA orthopedic device regulatory 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 - K033669

510(k) Number K033669 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 21, 2003
Decision Date December 10, 2003
Days to Decision 19 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
103d faster than avg
Panel avg: 122d · This submission: 19d
Pathway characteristics
Modification to existing cleared device.

HRS Device Classification - Class 2, Special Controls

Product Code HRS Plate, Fixation, Bone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3030
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 Orthopedic devices follow this clearance model.

Regulatory Peers - HRS Plate, Fixation, Bone

All 1332
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K033669.
VOLAR RADIUS PLATE WITH ANGULAR STABILITY
K033756 · I.T.S. Implantat-Technologie-Systeme GmbH · Feb 2004
TRIMED RADIAL BULLET
K030877 · Tri-Med, Inc. · Feb 2004
EVOLVE RADIAL PLATE
K033456 · Wrightmedicaltechnologyinc · Jan 2004
CANNULATED ARTHRORIVET AND CANNULATED RC ARTHRORIVET
K033519 · Biomet, Inc. · Dec 2003
GROWTH GUIDANCE PLATE
K031493 · University of Utah/School of Medicine · Nov 2003
ARTHREX FIBERWIRE BUTTON REPAIR KIT, MODEL AR-8920DS/AR-8921DS
K031666 · Arthrex, Inc. · Nov 2003
K033669 · SMITH & NEPHEW LOCKING BONE PLATE SYSTEM (LOCKING BONE PLATES AND SCREWS)
Download PDF FDA Summary Smith & Nephew, Inc.