Cleared Special

K052065 - ALLIANCE MEDICAL CORPORATION REPROCESSE...

K052065 is an FDA 510(k) clearance for ALLIANCE MEDICAL CORPORATION REPROCESSE..., manufactured by Alliance Medical Corp.. The device is a Class 2 Orthopedic device with product code KTT cleared through the Special 510(k) pathway after a 24-day FDA review.

K052065 · Alliance Medical Corp. · Orthopedic device
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Aug 2005
Decision
24d
Days
Class 2
Risk

K052065 is an FDA 510(k) clearance for the ALLIANCE MEDICAL CORPORATION 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 August 22, 2005 after a review of 24 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Alliance Medical Corp. devices

FDA 510(k) Submission Details - K052065

510(k) Number K052065 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 29, 2005
Decision Date August 22, 2005
Days to Decision 24 days
Submission Type Special
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
98d faster than avg
Panel avg: 122d · This submission: 24d
Pathway characteristics
Modification to existing cleared device.

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 K052065.
VANGUARD REPROCESSED EXTERNAL FIXATION DEVICES
K051616 · Vanguard Medical Concepts, Inc. · Sep 2005
ALLIANCE MEDICAL CORPORATION REPROCESSED EXTERNAL FIXATION DEVICES
K052062 · Alliance Medical Corp. · Aug 2005
ALLIANCE MEDICAL CORPORATION REPROCESSED EXTERNAL FIXATION DEVICES
K052064 · Alliance Medical Corp. · Aug 2005
MODIFICATION TO HOFFMANN II MICRO EXTERNAL FIXATION SYSTEM
K052037 · Howmedica Osteonics Corp. · Aug 2005
SYNTHES (USA) DISTRACTION OSTEOGENESIS SYSTEM
K051600 · Synthes (Usa) · Jul 2005
VANGUARD REPROCESSED EXTERNAL FIXATION DEVICES
K051180 · Vanguard Medical Concepts, Inc. · Jul 2005