Cleared Traditional

EBI X FIX DYNAFIX SYSTEM (DFS) (K953406) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K953406 · Electro-Biology, Inc. · Orthopedic device
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Oct 1995
Decision
103d
Days
Class 2
Risk

K953406 is an FDA 510(k) clearance for the EBI X FIX DYNAFIX SYSTEM (DFS). Classified as Appliance, Fixation, Nail/blade/plate Combination, Multiple Component (product code KTT), Class II - Special Controls.

Submitted by Electro-Biology, Inc. (Washington, US). The FDA issued a Cleared decision on October 31, 1995 after a review of 103 days - within the typical 510(k) review window.

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 Electro-Biology, Inc. devices

Submission Details

510(k) Number K953406 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 20, 1995
Decision Date October 31, 1995
Days to Decision 103 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
19d faster than avg
Panel avg: 122d · This submission: 103d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K953406.
ALTA DOME AND PLUNGER (MEC HIP BOLT)
K961213 · Howmedica Corp. · Jun 1996
OMEGA+ COMPRESSION SCREW SYSTEM
K955306 · Howmedica Corp. · Apr 1996
VERSA-FX FEMORAL FIXATION SYSTEM
K954555 · Zimmer, Inc. · Jan 1996
DEPUY COMPRESSION HIP SCREW SYSTEM
K946156 · Depuy, Inc. · May 1995
PEDIATRIC OSTEOTOMY SYSTEM
K945233 · Howmedica Corp. · Feb 1995
HOWMEDICA(R) MONO-TUBE(TM) EXTERNAL FIXATOR SYSTEM
K930836 · Howmedica Corp. · Jan 1995