An international leader in wear particle (debris) studies following biomechanical wear testing and biomechanical fatigue testing of orthopedic devices.  We analyse samples of either saline or serum containing wear particles (debris). These samples are generated during biomechanical testing of the articulating implant such as a spinal disc, artificial hip or knee replacement. Tests are also conducted on spinal implants such as posterior dynamic fixators, nucleus replacements and facet joint replacements. Wear particle (debris) studies are not limited to biomechanical wear testing, but are also relevant to biomechanical fatigue testing.  Biomechanical fatigue testing can result in the implant (whether artificial hip, knee spinal disc, nucleus replacement) generating wear particles (debris) which must also be analysed. 

All wear particle (debris) studies are conducted according to the ASTM F 1877 and ISO 1785 test specifications.  These tests are required by the FDA for the approval of new orthopedic implants, such as artificial hips, artificial knees, spinal discs, nucleus replacements, posterior dynamic fixators and facet joint replacement. 

6° of Freedom has over 6 years of experience in wear particle (debris) analysis.  We have conducted such studies for a number of multinational implant manufacturers wishing to obtain FDA approval or CE marking for a new product. Our reports are therefore used by companies completing FDA or CE mark submissions.

6° of Freedom are able to conduct analysis on ceramic metallic polymeric and elastomeric wear particles (debris) suspended in saline or serum, following either biomechanical fatigue testing or biomechanical wear testing.  We are able to analyze very fine wear particles (debris) and resolve wear particles (debris) down to 20nm using high resolution scanning electron microscopy, should this facility be required by the client.