Cleared Traditional

K912190 - STRYKER HIGH VACUUM BONE CEMENT MIXER/INJECT SYST

K912190 is an FDA 510(k) clearance for STRYKER HIGH VACUUM BONE CEMENT MIXER/I..., manufactured by Stryker Corp.. The device is a Class 1 Orthopedic device with 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

FDA 510(k) Submission Details - K912190

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.

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 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