Cleared Traditional

K962484 - SYNTHES TITANIUM EXTERNAL FIXATOR CLAMPS (TI EFC)

K962484 is an FDA 510(k) clearance for SYNTHES TITANIUM EXTERNAL FIXATOR CLAMP..., manufactured by Synthes (Usa). The device is a Class 2 Orthopedic device with product code KTT cleared through the Traditional 510(k) pathway after a 71-day FDA review.

K962484 · Synthes (Usa) · Orthopedic device
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Sep 1996
Decision
71d
Days
Class 2
Risk

K962484 is an FDA 510(k) clearance for the SYNTHES TITANIUM EXTERNAL FIXATOR CLAMPS (TI EFC). Classified as Appliance, Fixation, Nail/blade/plate Combination, Multiple Component (product code KTT), Class II - Special Controls.

Submitted by Synthes (Usa) (Paoli, US). The FDA issued a Cleared decision on September 5, 1996 after a review of 71 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Synthes (Usa) devices

FDA 510(k) Submission Details - K962484

510(k) Number K962484 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 26, 1996
Decision Date September 05, 1996
Days to Decision 71 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
51d faster than avg
Panel avg: 122d · This submission: 71d
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 358
Devices cleared under the same product code (KTT) and FDA review panel - the closest regulatory comparables to K962484.
MEDOFF SLIDING PLATE (PROPOSED NAME)
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ELLIS EXTERNAL MINI-FIXATOR SYSTEM
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MINIFIX
K964094 · Ferguson Medical · Nov 1996
ILIZAROV EXTERNAL FIXATION SYSTEM
K962808 · Smith & Nephew Richards, Inc. · Aug 1996
SYNTHES MINI EXTERNAL FIXATOR
K961350 · Synthes (Usa) · Jun 1996
EBI X FIX DYNAFIX SYSTEM/EBI DFS DISTAL RADIUS FIXATOR SC BONE SCREWS
K961433 · Electro-Biology, Inc. · Jun 1996