Cleared Traditional

MINIFIX (K964094) - FDA 510(k) Clearance

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

K964094 · Ferguson Medical · Orthopedic device
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Optimized for regulatory review, auditing and printing
Nov 1996
Decision
47d
Days
Class 2
Risk

K964094 is an FDA 510(k) clearance for the MINIFIX. Classified as Appliance, Fixation, Nail/blade/plate Combination, Multiple Component (product code KTT), Class II - Special Controls.

Submitted by Ferguson Medical (Chico, US). The FDA issued a Cleared decision on November 27, 1996 after a review of 47 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 Ferguson Medical devices

Submission Details

510(k) Number K964094 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 11, 1996
Decision Date November 27, 1996
Days to Decision 47 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
75d faster than avg
Panel avg: 122d · This submission: 47d
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 K964094.
SYNTHES COMBINATION CLAMP AND DYNAMIZATION CLIP
K973017 · Synthes (Usa) · Oct 1997
DEPUY AE TK2 HIP SCREW SYSTEM
K972629 · Depuy, Inc. · Oct 1997
MEDOFF SLIDING PLATE (PROPOSED NAME)
K962251 · Wrightmedicaltechnologyinc · Jan 1997
SYNTHES TITANIUM EXTERNAL FIXATOR CLAMPS (TI EFC)
K962484 · Synthes (Usa) · Sep 1996
SYNTHES MINI EXTERNAL FIXATOR
K961350 · Synthes (Usa) · Jun 1996
ALTA DOME AND PLUNGER (MEC HIP BOLT)
K961213 · Howmedica Corp. · Jun 1996