Cleared Traditional

REPROCESSED EXTERNAL FIXATION DEVICES (K052918) - FDA 510(k) Clearance

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

K052918 · Alliance Medical Corp. · Orthopedic device
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Jan 2006
Decision
102d
Days
Class 2
Risk

K052918 is an FDA 510(k) clearance for the REPROCESSED EXTERNAL FIXATION DEVICES. Classified as Appliance, Fixation, Nail/blade/plate Combination, Multiple Component (product code KTT), Class II - Special Controls.

Submitted by Alliance Medical Corp. (Phoenix, US). The FDA issued a Cleared decision on January 27, 2006 after a review of 102 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 Alliance Medical Corp. devices

Submission Details

510(k) Number K052918 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 17, 2005
Decision Date January 27, 2006
Days to Decision 102 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
20d faster than avg
Panel avg: 122d · This submission: 102d
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 K052918.
DEPUY PEAK FX HIP PLATE
K063509 · DePuy Orthopaedics, Inc. · Jan 2007
OMEGA 3 SYSTEM
K062066 · Howmedica Osteonics Corp. · Aug 2006
VARIAX LOCKING PLATE SYSTEM
K060613 · Howmedica Osteonics Corp. · Apr 2006
HOFFMANN II MRI EXTERNAL FIXATION SYSTEM
K053472 · Howmedica Osteonics Corp. · Jan 2006
HOFFMANN II ROD TO WIRE COUPLING
K053349 · Howmedica Osteonics Corp. · Dec 2005
HOFFMANN II COMPACT MRI EXTERNAL FIXATION SYSTEM
K053038 · Howmedica Osteonics Corp. · Nov 2005