Cleared Traditional

ETHICON EXTERNAL FIXATION WIRE (K821178) - FDA 510(k) Clearance

Class I General & Plastic Surgery device.

K821178 · Ethicon, Inc. · General & Plastic Surgery device
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Jun 1983
Decision
410d
Days
Class 1
Risk

K821178 is an FDA 510(k) clearance for the ETHICON EXTERNAL FIXATION WIRE. Classified as Appliance, Facial Fracture, External (product code FYI), Class I - General Controls.

Submitted by Ethicon, Inc. (Walker, US). The FDA issued a Cleared decision on June 11, 1983 after a review of 410 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.3250 - the FDA general and plastic surgery device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General & Plastic Surgery submissions.

View all Ethicon, Inc. devices

Submission Details

510(k) Number K821178 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 27, 1982
Decision Date June 11, 1983
Days to Decision 410 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
295d slower than avg
Panel avg: 115d · This submission: 410d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code FYI Appliance, Facial Fracture, External
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.3250
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.