Cleared Traditional

K012648 - REPROCESSED HOWMEDICA EXTERNAL FIXATION...

K012648 is an FDA 510(k) clearance for REPROCESSED HOWMEDICA EXTERNAL FIXATION..., 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 315-day FDA review.

K012648 · Alliance Medical Corp. · Orthopedic device
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Jun 2002
Decision
315d
Days
Class 2
Risk

K012648 is an FDA 510(k) clearance for the REPROCESSED HOWMEDICA 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 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 - K012648

510(k) Number K012648 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.

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 K012648.
TEMPFIX EXTERNAL FIXATION SYSTEM
K021933 · DePuy Orthopaedics, Inc. · Aug 2002
EBI XFIX DFS SYSTEM
K022319 · Ebi, L.P. · Aug 2002
REPROCESSED EXTERNAL FIXATION DEVICE
K012623 · Alliance Medical Corp. · Jun 2002
EBI DYNAFIX DIAPHYSEAL CORRECTION SYSTEM
K021695 · Ebi, L.P. · Jun 2002
OMEGA II SYSTEM
K020772 · Howmedica Osteonics Corp. · Jun 2002
EBI DFS OPTIROM ELBOW FIXATOR
K021312 · Ebi, L.P. · May 2002