Cleared Traditional

REPROCESSED EXTERNAL FIXATION ACCESSORIES (K081342) - FDA 510(k) Clearance

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

K081342 · Sterilmed, Inc. · Orthopedic device
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Aug 2008
Decision
92d
Days
Class 2
Risk

K081342 is an FDA 510(k) clearance for the REPROCESSED EXTERNAL FIXATION ACCESSORIES. Classified as Appliance, Fixation, Nail/blade/plate Combination, Multiple Component (product code KTT), Class II - Special Controls.

Submitted by Sterilmed, Inc. (Maple Grove, US). The FDA issued a Cleared decision on August 13, 2008 after a review of 92 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 Sterilmed, Inc. devices

Submission Details

510(k) Number K081342 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 13, 2008
Decision Date August 13, 2008
Days to Decision 92 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
30d faster than avg
Panel avg: 122d · This submission: 92d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KTT Appliance, Fixation, Nail/blade/plate Combination, Multiple Component
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 - KTT Appliance, Fixation, Nail/blade/plate Combination, Multiple Component

All 175
Devices cleared under the same product code (KTT) and FDA review panel - the closest regulatory comparables to K081342.
SMITH & NEPHEW RAIL SYSTEM
K090926 · Smith & Nephew, Inc. · Jun 2009
ACE FISCHER EXTERNAL FIXATION SYSTEM
K083789 · DePuy Orthopaedics, Inc. · Mar 2009
SYNTHES LARGE EXTERNAL FIXATION, MR CONDITIONAL
K082650 · Synthes (Usa) · Nov 2008
VARIAX DISTAL FIBULA PLATE
K081284 · Howmedica Osteonics Corp. · Jul 2008
OMEGA 3 TROCHANTERIC STABILIZING PLATE
K081278 · Howmedica Osteonics Corp. · May 2008
JET-X BAR SYSTEM CLAMPS, BARS AND POSTS-MR SAFE
K072212 · Smith & Nephew, Inc. · Mar 2008