Standard Guide for Assessment of Hard-on-Hard Articulation in Total Hip Joint Replacement and Resurfacing Hip Joint Replacement

Importancia y uso:

4.1 This document provides guidance for a range of assessments and evaluations to aid in preclinical research and device development of hard-on-hard total and resurfacing hip joint replacements used for the repair of musculoskeletal disorders.

4.2 The user is encouraged to use appropriate ASTM or ISO standards to conduct the physical, chemical, mechanical, biocompatibility, and preclinical tests on alloy fabricated forms, ceramic material samples, device components, or devices before assessment in an in vitro model.

4.3 Studies to support regulatory submissions should conform to appropriate regulatory requirements and guidelines for the development of medical devices.

4.4 Assessments with physical, chemical, mechanical, biocompatibility, and preclinical tests on hard-on-hard femoral and acetabular components are not necessarily predictive of human results and therefore should be interpreted cautiously with respect to potential applicability to clinical conditions. Referenced metal-on-metal or ceramic-on-ceramic hip joint replacement publications can be found in the References section at the end of this guide for further review.

Subcomité:

F04.22

Referida por:

F3047M-23

Volúmen:

13.02

Número ICS:

11.040.40 (Implants for surgery, prosthetics and orthotics)

Palabras clave:

ceramic-on-ceramic; cobalt-28% chromium-6% molybdenum alloy; Co28Cr6Mo; Ti-6Al-4V alloy; high purity alumina; high purity alumina matrix composite; hip resurfacing; metal-on-ceramic; metal-on-metal; modular acetabular component; musculoskeletal joint replacement; orthopedic device; total hip arthroplasty; total hip joint replacement;