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Significance and Use
The tests suggested within this guide cover many different, but not all possible, areas of research and concern with regard to modular hip stems and modular knee components.
Due to the unlimited possible modular designs, this guide should be utilized as a guide for what should be considered with regard to device safety testing. There may be circumstances where alternative test methods may be useful. It is still the responsibility of the investigator to address all safety concerns that are inherent to individual modular designs.
The tests suggested herein should be utilized in such a way that the results reflect the effects of modularity, if any.
Tests that are checked in Fig. 1 or Fig. 2 or indicated in this guide as a possible test to consider may not be applicable to every implant design.
FIG. 1 Total Hip Implants
FIG. 2 Total Knee Implant
1.1 This guide covers a procedure to assist the developer of a modular joint replacement implant in the choice of appropriate tests and evaluations to determine device safety.
1.2 This guide does not attempt to define all test methods associated with modular device evaluation.
1.3 This guide does not cover intentional intraoperative disassembly but is meant only to suggest testing necessary to determine inadvertent disassembly loads.
1.4 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.
2. Referenced Documents (purchase separately) The documents listed below are referenced within the subject standard but are not provided as part of the standard.
F648 Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants
F897 Test Method for Measuring Fretting Corrosion of Osteosynthesis Plates and Screws
F1440 Practice for Cyclic Fatigue Testing of Metallic Stemmed Hip Arthroplasty Femoral Components Without Torsion
F1800 Test Method for Cyclic Fatigue Testing of Metal Tibial Tray Components of Total Knee Joint Replacements
ICS Number Code 11.040.40 (Implants for surgery, prothetics and orthotics)
UNSPSC Code 42321700(Hip joint implants); 42321800(Knee joint implants)