Cleared Traditional

K861086 - ZIMMER VACUUM MIXING SYSTEM

K861086 is an FDA 510(k) clearance for ZIMMER VACUUM MIXING SYSTEM, 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 24-day FDA review.

K861086 · Zimmer, Inc. · Orthopedic device
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Apr 1986
Decision
24d
Days
Class 1
Risk

K861086 is an FDA 510(k) clearance for the ZIMMER VACUUM MIXING SYSTEM. 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 April 14, 1986 after a review of 24 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 Zimmer, Inc. devices

FDA 510(k) Submission Details - K861086

510(k) Number K861086 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 21, 1986
Decision Date April 14, 1986
Days to Decision 24 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
98d faster than avg
Panel avg: 122d · This submission: 24d
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 K861086.
PRISM BONE CEMENT MIXING SYSTEM
K925025 · Depuy, Inc. · Jan 1994
STRYKER HIGH VACUUM BONE CEMENT MIXER/INJECT SYST
K912190 · Stryker Corp. · Aug 1991
REUSABLE BOWL AND SPATULA FOR MIXING BONE CEMENTS
K892937 · Dentsply Intl. · Jun 1989
MIX EVAC II
K854077 · Stryker Corp. · Jan 1986
SIMPLEX ENHANCEMENT MIXER
K853310 · Howmedica Corp. · Sep 1985
CEMENTRIFUGE
K851205 · Biodynamic Technologies, Inc. · Jul 1985