Orthopedic Implant Wear and Fatigue Testing
If you want a cost effective and comprehensive wear testing service from a reliable, ISO-17025 accredited supplier, then Lucideon has the facilities and expertise to ensure your orthopedic devices are fit for purpose over the lifetime of the implant. Our engineers have years of experience using the latest generation, gold-standard simulators to provide wear testing of hips, knees, spines, and small joints, such as ankles and shoulders. We conform to a range of ASTM and ISO standards, but also often design and develop novel fixtures and frame modifications to accommodate complex designs.
If you are looking to:
- Simulate and evaluate the wear performance of your new bearing materials, or compare a new design with an existing one.
- Outsource your orthopedic implant wear testing to accelerate new product developments and avoid in-house delays.
- Find a supplier that can provide a comprehensive service and the full suite of information you require for your regulatory submission.
- Find out what is happening at the surface of your material.
then we can help.
Using the latest AMTI and ProSim wear simulators, we test new devices for regulatory submissions and evaluate the performance of existing products. ISO 17025 accredited, we work to universally accepted ISO and ASTM standards, but can also help you to develop test methods for joints where standards are not yet available. Our in-house machine shop allows us to make design-specific fixtures in order to expedite the process of beginning a test on a new design.
- Simulated wear and impingement wear testing, including fixture design and machining to ISO 14242 (hip), ISO 14243 (knee) and ASTM F2582-14 (impingement)
- Fatigue and mechanical testing of hip, knee, shoulder, spine, ankle, and other implants
- Debris analysis to ISO 17853 and ASTM F1877
- Surface roughness and surface imaging
- Polymer aging to ASTM F2003.
Using a combination of techniques we offer analysis of wear debris generated. In addition to following the ASTM standard, using SEM evaluation to provide qualitative information, we also use laser diffraction techniques to gather more detailed, quantitative information such as particle size distribution, and chemical analysis to understand the composition of the particles.
As well as extensive mechanical, physical and chemical testing, we are able, through our world-leading surface analysis facilities, to give you a real understanding of what is happening at the interface between your materials.
- Does a coating or process used to improve the hardness/wear properties of your component affect the base material in any way?
- Does the articulation cause material transfer or migration across the interface or into the surface that could be detrimental?
- Is a chemical reaction occurring between the dissimilar materials and affecting the properties or biocompatibility of the components?
- Is the wear pattern consistent and, if not, is it because of the materials or the design?
We also have a representative in Asia, the Hong Kong Standards and Testing Centre. They can be contacted on Tel: +852 2666 1888, Email : firstname.lastname@example.org
STC Medical Device Services
Through a partnership with Lucideon STC provides regulatory support, materials analysis, product classification, testing, registration and licensing of joint medical devices.
STC is presently providing comprehensive biocompatibility assessments in accordance with requirements mandated by different regulatory bodies, including: in-vitro cytotoxicity, skin sensitization, irritation and acute toxicity etc. In collaboration with Lucideon, they are able to provide a one-stop medical device service.