Cleared Traditional

ELLIS EXTERNAL MINI-FIXATOR SYSTEM (K964458) - FDA 510(k) Clearance

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

K964458 · Link America, Inc. · Orthopedic device
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Dec 1996
Decision
32d
Days
Class 2
Risk

K964458 is an FDA 510(k) clearance for the ELLIS EXTERNAL MINI-FIXATOR SYSTEM. Classified as Appliance, Fixation, Nail/blade/plate Combination, Multiple Component (product code KTT), Class II - Special Controls.

Submitted by Link America, Inc. (Sarasota, US). The FDA issued a Cleared decision on December 9, 1996 after a review of 32 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 Link America, Inc. devices

Submission Details

510(k) Number K964458 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 07, 1996
Decision Date December 09, 1996
Days to Decision 32 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
90d faster than avg
Panel avg: 122d · This submission: 32d
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 K964458.
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