Cleared Traditional

REPROCESSED EXTERNAL FIXATION DEVICE (K081586) - FDA 510(k) Clearance

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

K081586 · Sterilmed, Inc. · Orthopedic device
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Optimized for regulatory review, auditing and printing
Aug 2008
Decision
74d
Days
Class 2
Risk

K081586 is an FDA 510(k) clearance for the REPROCESSED EXTERNAL FIXATION DEVICE. 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 18, 2008 after a review of 74 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Sterilmed, Inc. devices

Submission Details

510(k) Number K081586 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 05, 2008
Decision Date August 18, 2008
Days to Decision 74 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
48d faster than avg
Panel avg: 122d · This submission: 74d
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 K081586.
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