Cleared Traditional

CMW CEMENT PRESSURISATION SYSTEM (K897134) - FDA 510(k) Clearance

Class I Orthopedic device.

K897134 · Dentsply Intl. · Orthopedic device
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Mar 1990
Decision
65d
Days
Class 1
Risk

K897134 is an FDA 510(k) clearance for the CMW CEMENT PRESSURISATION SYSTEM. Classified as Dispenser, Cement (product code KIH), Class I - General Controls.

Submitted by Dentsply Intl. (York, US). The FDA issued a Cleared decision on March 2, 1990 after a review of 65 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.4200 - 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 Dentsply Intl. devices

Submission Details

510(k) Number K897134 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 27, 1989
Decision Date March 02, 1990
Days to Decision 65 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
57d faster than avg
Panel avg: 122d · This submission: 65d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KIH Dispenser, Cement
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 888.4200
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 - KIH Dispenser, Cement

All 9
Devices cleared under the same product code (KIH) and FDA review panel - the closest regulatory comparables to K897134.
SMARTMIX PRE-FILLED MIXING SYSTEM
K042591 · DePuy Orthopaedics, Inc. · Oct 2004
P.F.C. CEMENT PRESSURIZING SYSTEM
K943906 · Johnson & Johnson Professionals, Inc. · Dec 1994
ORTHOPEADIC CEMENT DELIVERY SYSTEM
K851881 · Dentsply Intl. · Jun 1985
BRIGHAM TIBIAL CEMENT PRESSURIZER
K833675 · Howmedica Corp. · Dec 1983
HOWMEDICA FEMORAL PRESSURING SEAL
K811317 · Howmedica Corp. · May 1981
OH-HARRIS
K801388 · Johnson & Johnson Professionals, Inc. · Jul 1980