Cleared Traditional

K012645 - REPROCESSED EBI EXTERNAL FIXATION DEVICES

K012645 is an FDA 510(k) clearance for REPROCESSED EBI EXTERNAL FIXATION DEVICES, manufactured by Alliance Medical Corp.. The device is a Class 2 Orthopedic device with product code KTW cleared through the Traditional 510(k) pathway after a 315-day FDA review.

K012645 · Alliance Medical Corp. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2002
Decision
315d
Days
Class 2
Risk

K012645 is an FDA 510(k) clearance for the REPROCESSED EBI EXTERNAL FIXATION DEVICES. Classified as Appliance, Fixation, Nail/blade/plate Combination, Single Component (product code KTW), Class II - Special Controls.

Submitted by Alliance Medical Corp. (Phoenix, US). The FDA issued a Cleared decision on June 24, 2002 after a review of 315 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 - K012645

510(k) Number K012645 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 13, 2001
Decision Date June 24, 2002
Days to Decision 315 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
193d slower than avg
Panel avg: 122d · This submission: 315d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KTW Device Classification - Class 2, Special Controls

Product Code KTW Appliance, Fixation, Nail/blade/plate Combination, Single 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 - KTW Appliance, Fixation, Nail/blade/plate Combination, Single Component

All 22
Devices cleared under the same product code (KTW) and FDA review panel - the closest regulatory comparables to K012645.
SYNTHES (USA) MODULAR BLADE PLATE SYSTEM
K080109 · Synthes (Usa) · Mar 2008
ORTHOFIX TITANIUM HUMERAL PLATING SYSTEM LSP
K062920 · Orthofix Srl · Nov 2006
LEFORTE SYSTEM BONE PLATE
K023360 · Jeil Medical Corporation · Oct 2002
SYNTHES LCP PROXIMAL HUMERUS PLATES
K011815 · Synthes (Usa) · Sep 2001
SYNTHES STRAIGHT WRIST FUSION PLATE, 170MM
K011458 · Synthes (Usa) · Aug 2001
MODULAR FOOT SYSTEM - 2.7 MM MODULE
K010321 · Synthes (Usa) · May 2001