Cleared Traditional

K853310 - SIMPLEX ENHANCEMENT MIXER (FDA 510(k) Clearance)

Class I Orthopedic device.

K853310 · Howmedica Corp. · Orthopedic device
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Sep 1985
Decision
35d
Days
Class 1
Risk

K853310 is an FDA 510(k) clearance for the SIMPLEX ENHANCEMENT MIXER. Classified as Mixer, Cement, For Clinical Use (product code JDZ), Class I - General Controls.

Submitted by Howmedica Corp. (Rutherford, US). The FDA issued a Cleared decision on September 11, 1985 after a review of 35 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.4210 - 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 Howmedica Corp. devices

Submission Details

510(k) Number K853310 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 07, 1985
Decision Date September 11, 1985
Days to Decision 35 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
87d faster than avg
Panel avg: 122d · This submission: 35d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JDZ Mixer, Cement, For Clinical Use
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 888.4210
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.