Cleared Traditional

K081342 - REPROCESSED EXTERNAL FIXATION ACCESSORIES

K081342 is an FDA 510(k) clearance for REPROCESSED EXTERNAL FIXATION ACCESSORIES, manufactured by Sterilmed, Inc.. The device is a Class 2 Orthopedic device with product code KTT cleared through the Traditional 510(k) pathway after a 92-day FDA review.

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

FDA 510(k) Submission Details - K081342

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
Combination Product No
PCCP Authorized No
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.

KTT Device Classification - Class 2, Special Controls

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 363
Devices cleared under the same product code (KTT) and FDA review panel - the closest regulatory comparables to K081342.
NBX - NON-BRIDGING EXTERNAL FIXATOR - SHOULDER
K082833 · Nutek Orthopaedics, Inc. · Feb 2009
SYNTHES LARGE EXTERNAL FIXATION, MR CONDITIONAL
K082650 · Synthes (Usa) · Nov 2008
REPROCESSED EXTERNAL FIXATION DEVICE
K081586 · Sterilmed, Inc. · Aug 2008
LOWER EXTREMITY EXTERNAL FIXATION - EXPANDED INDICATIONS
K081244 · Biomet Trauma · Jul 2008
VARIAX DISTAL FIBULA PLATE
K081284 · Howmedica Osteonics Corp. · Jul 2008
OMEGA 3 TROCHANTERIC STABILIZING PLATE
K081278 · Howmedica Osteonics Corp. · May 2008