Cleared Traditional

EVOLVE RADIAL PLATE (K033456) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K033456 · Wrightmedicaltechnologyinc · Orthopedic device
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Jan 2004
Decision
90d
Days
Class 2
Risk

K033456 is an FDA 510(k) clearance for the EVOLVE RADIAL PLATE. Classified as Plate, Fixation, Bone within the HRS classification (a category comprising bone fixation plates and orthopedic hardware), Class II - Special Controls.

Submitted by Wrightmedicaltechnologyinc (Arlington, US). The FDA issued a Cleared decision on January 28, 2004 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3030 - the FDA orthopedic device regulatory 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. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Wrightmedicaltechnologyinc devices

Submission Details

510(k) Number K033456 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 30, 2003
Decision Date January 28, 2004
Days to Decision 90 days
Submission Type Traditional
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
32d faster than avg
Panel avg: 122d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 695
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K033456.
LCP RADIAL HEAD PLATING SYSTEM
K040777 · Synthes (Usa) · Jun 2004
SYNTHES (USA) 2.4 MM LCP WRIST PLATE
K040588 · Synthes (Usa) · May 2004
PERIARTICULAR LOCKING PLATES AND SCREWS, 2358, 2359 SERIES
K040593 · Zimmer, Inc. · Apr 2004
SMITH & NEPHEW LOCKING BONE PLATE SYSTEM (LOCKING BONE PLATES AND SCREWS)
K033669 · Smith & Nephew, Inc. · Dec 2003
CANNULATED ARTHRORIVET AND CANNULATED RC ARTHRORIVET
K033519 · Biomet, Inc. · Dec 2003
ARTHREX FIBERWIRE BUTTON REPAIR KIT, MODEL AR-8920DS/AR-8921DS
K031666 · Arthrex, Inc. · Nov 2003