Cleared Traditional

K851205 - CEMENTRIFUGE

K851205 is an FDA 510(k) clearance for CEMENTRIFUGE, manufactured by Biodynamic Technologies, Inc.. The device is a Class 1 Orthopedic device with product code JDZ cleared through the Traditional 510(k) pathway after a 112-day FDA review.

K851205 · Biodynamic Technologies, Inc. · Orthopedic device
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Jul 1985
Decision
112d
Days
Class 1
Risk

K851205 is an FDA 510(k) clearance for the CEMENTRIFUGE. Classified as Mixer, Cement, For Clinical Use (product code JDZ), Class I - General Controls.

Submitted by Biodynamic Technologies, Inc. (Arlington, US). The FDA issued a Cleared decision on July 16, 1985 after a review of 112 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 Biodynamic Technologies, Inc. devices

FDA 510(k) Submission Details - K851205

510(k) Number K851205 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 26, 1985
Decision Date July 16, 1985
Days to Decision 112 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
10d faster than avg
Panel avg: 122d · This submission: 112d
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 K851205.
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
ZIMMER BONE CEMENT CENTRIFUGATION SYS
K843219 · Zimmer, Inc. · Nov 1984
HOWMEDICA MIX-KIT II
K792186 · Howmedica Corp. · Dec 1979
MIXING BOWL & SPATULA, DISPOSABLE
K780857 · Howmedica Corp. · Jun 1978