Cleared Traditional

K052918 - REPROCESSED EXTERNAL FIXATION DEVICES

K052918 is an FDA 510(k) clearance for REPROCESSED EXTERNAL FIXATION DEVICES, manufactured by Alliance Medical Corp.. The device is a Class 2 Orthopedic device with product code KTT cleared through the Traditional 510(k) pathway after a 102-day FDA review.

K052918 · Alliance Medical Corp. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K052918

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
Combination Product No
PCCP Authorized No
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.

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 287
Devices cleared under the same product code (KTT) and FDA review panel - the closest regulatory comparables to K052918.
OMEGA 3 SYSTEM
K062066 · Howmedica Osteonics Corp. · Aug 2006
UNITY HUMERAL PLATE
K060545 · Tornier · Apr 2006
VARIAX LOCKING PLATE SYSTEM
K060613 · Howmedica Osteonics Corp. · Apr 2006
HOFFMANN II MRI EXTERNAL FIXATION SYSTEM
K053472 · Howmedica Osteonics Corp. · Jan 2006
VANGUARD REPROCESSED EXTERNAL FIXATION DEVICES
K053051 · Vanguard Medical Concepts, Inc. · Dec 2005
HOFFMANN II ROD TO WIRE COUPLING
K053349 · Howmedica Osteonics Corp. · Dec 2005