Cleared Traditional

K925025 - PRISM BONE CEMENT MIXING SYSTEM (FDA 510(k) Clearance)

Class I Orthopedic device.

K925025 · Depuy, Inc. · Orthopedic device
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Jan 1994
Decision
460d
Days
Class 1
Risk

K925025 is an FDA 510(k) clearance for the PRISM BONE CEMENT MIXING SYSTEM. Classified as Mixer, Cement, For Clinical Use (product code JDZ), Class I - General Controls.

Submitted by Depuy, Inc. (Warsaw, US). The FDA issued a Cleared decision on January 5, 1994 after a review of 460 days - an unusually long review period, suggesting complex equivalence evaluation.

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: 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 Orthopedic submissions.

View all Depuy, Inc. devices

Submission Details

510(k) Number K925025 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 02, 1992
Decision Date January 05, 1994
Days to Decision 460 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
338d slower than avg
Panel avg: 122d · This submission: 460d
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.