Cleared Traditional

GROWTH GUIDANCE PLATE (K031493) - FDA 510(k) Clearance

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

K031493 · University of Utah/School of Medicine · Orthopedic device
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Nov 2003
Decision
192d
Days
Class 2
Risk

K031493 is an FDA 510(k) clearance for the GROWTH GUIDANCE 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 University of Utah/School of Medicine (Salt Lake City, US). The FDA issued a Cleared decision on November 20, 2003 after a review of 192 days - an extended review cycle.

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 University of Utah/School of Medicine devices

Submission Details

510(k) Number K031493 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 12, 2003
Decision Date November 20, 2003
Days to Decision 192 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
70d slower than avg
Panel avg: 122d · This submission: 192d
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 696
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K031493.
EVOLVE RADIAL PLATE
K033456 · Wrightmedicaltechnologyinc · Jan 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
SYNTHES 4.0MM TITANIUM (TI.) LOCKING SCREWS
K032559 · Synthes (Usa) · Oct 2003
ANTHREX TITANIUM OPENING WEDGE OSTEOTOMY SYSTEM
K032187 · Arthrex, Inc. · Sep 2003