Cleared Traditional

K964400 - ALPHATEC EXTERNAL FIXATION SYSTEM

K964400 is an FDA 510(k) clearance for ALPHATEC EXTERNAL FIXATION SYSTEM, manufactured by Alphatec Mfg., Inc.. The device is a Class 2 Orthopedic device with product code KTT cleared through the Traditional 510(k) pathway after a 175-day FDA review.

K964400 · Alphatec Mfg., Inc. · Orthopedic device
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Apr 1997
Decision
175d
Days
Class 2
Risk

K964400 is an FDA 510(k) clearance for the ALPHATEC EXTERNAL FIXATION SYSTEM. Classified as Appliance, Fixation, Nail/blade/plate Combination, Multiple Component (product code KTT), Class II - Special Controls.

Submitted by Alphatec Mfg., Inc. (Palm Desert, US). The FDA issued a Cleared decision on April 28, 1997 after a review of 175 days - an extended review cycle.

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 Alphatec Mfg., Inc. devices

FDA 510(k) Submission Details - K964400

510(k) Number K964400 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 04, 1996
Decision Date April 28, 1997
Days to Decision 175 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
53d slower than avg
Panel avg: 122d · This submission: 175d
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 312
Devices cleared under the same product code (KTT) and FDA review panel - the closest regulatory comparables to K964400.
HOFFMANN II COMPACT PERIARTICULAR CLAMP
K973321 · Howmedica, Inc. · Nov 1997
SYNTHES COMBINATION CLAMP AND DYNAMIZATION CLIP
K973017 · Synthes (Usa) · Oct 1997
DEPUY AE TK2 HIP SCREW SYSTEM
K972629 · Depuy, Inc. · Oct 1997
EBI X FIX DYNAFIX MINI EXTERNAL FIXATION SYSTEM
K970290 · Ebi, L.P. · Apr 1997
MEDOFF SLIDING PLATE (PROPOSED NAME)
K962251 · Wrightmedicaltechnologyinc · Jan 1997
ELLIS EXTERNAL MINI-FIXATOR SYSTEM
K964458 · Link America, Inc. · Dec 1996