Cleared Traditional

THE UNIVERSAL BONE CEMENT RESISTOR (K924323) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K924323 · Biodynamic Technologies, Inc. · Orthopedic device
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Feb 1993
Decision
169d
Days
Class 2
Risk

K924323 is an FDA 510(k) clearance for the THE UNIVERSAL BONE CEMENT RESISTOR. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented (product code JDI), Class II - Special Controls.

Submitted by Biodynamic Technologies, Inc. (Arlington, US). The FDA issued a Cleared decision on February 12, 1993 after a review of 169 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3350 - 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

Submission Details

510(k) Number K924323 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 27, 1992
Decision Date February 12, 1993
Days to Decision 169 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
47d slower than avg
Panel avg: 122d · This submission: 169d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JDI Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3350
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Orthopedic devices follow this clearance model.

Regulatory Peers - JDI Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented

All 280
Devices cleared under the same product code (JDI) and FDA review panel - the closest regulatory comparables to K924323.
HOWMEDICA REVISION HIP SYSTEM
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EXACTECH FEMORAL STEM
K925201 · Exactech, Inc. · Jun 1993
STABILITY HIP FEMORAL COMPONENT
K915594 · Depuy, Inc. · Apr 1993
DEPUY HIP PROSTHESIS
K914078 · Depuy, Inc. · Jan 1993
HOWMEDICA(R) HNR SYSTEM
K922503 · Howmedica Corp. · Sep 1992
RX 90 ACETABULAR COMPONENT SYSTEM
K920639 · Biomet, Inc. · Jun 1992