Cleared Traditional

K843219 - ZIMMER BONE CEMENT CENTRIFUGATION SYS

K843219 is an FDA 510(k) clearance for ZIMMER BONE CEMENT CENTRIFUGATION SYS, manufactured by Zimmer, Inc.. The device is a Class 1 Orthopedic device with product code JDZ cleared through the Traditional 510(k) pathway after a 106-day FDA review.

K843219 · Zimmer, Inc. · Orthopedic device
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Nov 1984
Decision
106d
Days
Class 1
Risk

K843219 is an FDA 510(k) clearance for the ZIMMER BONE CEMENT CENTRIFUGATION SYS. Classified as Mixer, Cement, For Clinical Use (product code JDZ), Class I - General Controls.

Submitted by Zimmer, Inc. (Warsaw, US). The FDA issued a Cleared decision on November 29, 1984 after a review of 106 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Zimmer, Inc. devices

FDA 510(k) Submission Details - K843219

510(k) Number K843219 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 15, 1984
Decision Date November 29, 1984
Days to Decision 106 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
16d faster than avg
Panel avg: 122d · This submission: 106d
Pathway characteristics
Predicate-based equivalence.

JDZ Device Classification - Class 1, General Controls

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.

Regulatory Peers - JDZ Mixer, Cement, For Clinical Use

All 11
Devices cleared under the same product code (JDZ) and FDA review panel - the closest regulatory comparables to K843219.
MIX EVAC II
K854077 · Stryker Corp. · Jan 1986
SIMPLEX ENHANCEMENT MIXER
K853310 · Howmedica Corp. · Sep 1985
CEMENTRIFUGE
K851205 · Biodynamic Technologies, Inc. · Jul 1985
HOWMEDICA MIX-KIT II
K792186 · Howmedica Corp. · Dec 1979
MIXING BOWL & SPATULA, DISPOSABLE
K780857 · Howmedica Corp. · Jun 1978
MIX EVAC BONE CEMENT
K760617 · Stryker Corp. · Oct 1976