Cleared Traditional

K912190 - STRYKER HIGH VACUUM BONE CEMENT MIXER/I...

K912190 is the FDA 510(k) clearance for STRYKER HIGH VACUUM BONE CEMENT MIXER/I... by Stryker Corp.. It is a Class 1 Orthopedic device (product code JDZ) cleared through the Traditional 510(k) pathway after a 104-day FDA review.

K912190 · Stryker Corp. · Orthopedic device
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Aug 1991
Decision
104d
Days
Class 1
Risk

K912190 is an FDA 510(k) clearance for the STRYKER HIGH VACUUM BONE CEMENT MIXER/INJECT SYST. Classified as Mixer, Cement, For Clinical Use (product code JDZ), Class I - General Controls.

Submitted by Stryker Corp. (Kalamazoo, US). The FDA issued a Cleared decision on August 29, 1991 after a review of 104 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 Stryker Corp. devices

Submission Details

510(k) Number K912190 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 17, 1991
Decision Date August 29, 1991
Days to Decision 104 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
18d faster than avg
Panel avg: 122d · This submission: 104d
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.

Regulatory Peers - JDZ Mixer, Cement, For Clinical Use

All 10
Devices cleared under the same product code (JDZ) and FDA review panel - the closest regulatory comparables to K912190.
EXACTECH ALL POLY ACETABULAR CUP
K934253 · Exactech, Inc. · Apr 1994
PRISM BONE CEMENT MIXING SYSTEM
K925025 · Depuy, Inc. · Jan 1994
REUSABLE BOWL AND SPATULA FOR MIXING BONE CEMENTS
K892937 · Dentsply Intl. · Jun 1989
ZIMMER VACUUM MIXING SYSTEM
K861086 · Zimmer, Inc. · Apr 1986
MIX EVAC II
K854077 · Stryker Corp. · Jan 1986
SIMPLEX ENHANCEMENT MIXER
K853310 · Howmedica Corp. · Sep 1985