Cleared Special

ALLIANCE MEDICAL CORPORATION REPROCESSED EXTERNAL FIXATION DEVICES (K051554) - FDA 510(k) Clearance

Class II Orthopedic device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K051554 · Alliance Medical Corp. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2005
Decision
16d
Days
Class 2
Risk

K051554 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 June 29, 2005 after a review of 16 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

Submission Details

510(k) Number K051554 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 13, 2005
Decision Date June 29, 2005
Days to Decision 16 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
106d faster than avg
Panel avg: 122d · This submission: 16d
Pathway characteristics
Modification to existing cleared device.

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 K051554.
MODIFICATION TO HOFFMANN II MICRO EXTERNAL FIXATION SYSTEM
K052037 · Howmedica Osteonics Corp. · Aug 2005
SYNTHES (USA) DISTRACTION OSTEOGENESIS SYSTEM
K051600 · Synthes (Usa) · Jul 2005
SYNTHES (USA) LOW-PROFILE WRIST FIXATOR
K051049 · Synthes (Usa) · Jul 2005
HA COATED LAG SCREW
K050849 · Smith & Nephew, Inc. · May 2005
HOFFMAN II MICRO EXTERNAL FIXATION SYSTEM
K050048 · Howmedica Osteonics Corp. · Mar 2005
TEMPFIX EXTERNAL FIXATION SYSTEM, MR SAFE
K043113 · DePuy Orthopaedics, Inc. · Jan 2005