Standard Guide for Evaluating Modular Hip and Knee Joint Components

Importancia y uso:

4.1 The tests suggested within this guide cover many different, but not all possible, areas of research and concern with regard to modular hip and modular knee components.

4.2 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.

4.3 The tests suggested herein should be utilized in such a way that the results reflect the effects of modularity, if any.

4.4 Tests that are checked in Table 1, Table 2, or Table 3 or indicated in this guide as a possible test to consider may not be applicable to every implant design.

Subcomité:

F04.22

Referida por:

F2887-23, F2665-21, F3018-17

Volúmen:

13.01

Número ICS:

11.040.40 (Implants for surgery, prothetics and orthotics)

Palabras clave:

arthroplasty; disassembly; hip arthroplasty; knee arthroplasty; modular; orthopaedic medical devices;