RJ Lee Group’s (RJLG) medical device experts exhibited at the 22nd Annual Meeting of the North American Spine Society (NASS) in Austin, Texas, October 23-27, 2007, at the Austin Convention Center.
Wear fatigue and debris characterization is one of the services that our medical device experts provide, using a variety of analytical techniques, including Computer-Controlled Scanning Electron Microscopy (CCSEM), Raman microscopy, polarized light microscopy, and FTIR. We employ ASTM Test Method F 1877, which encompasses a series of procedures (including optical microscopy, SEM and energy dispersive X-ray (EDS) analysis) for characterization of the morphology, quantity, size, and size distribution of particles produced by wear test machines, total joint simulation systems, and abrasion testing. Additional medical device laboratory services include contamination identification, high resolution SEM imaging, particle sizing / characterization, technical support of FDA submittals, forensic defect analysis, device cleanliness assessments and litigation support services.
RJ Lee Group has consistently demonstrated the ability to provide the highest quality particulate analysis of wear debris from tested spinal implant assemblies, and has directly contributed to several successful applications for FDA approval. The ability to analyze such a high number of particles in such a short amount of time through the use of computer controlled SEM techniques reduces assumptions about how representative a given sample is, and provides the customer with a much higher level of confidence in the data. Furthermore, RJ Lee Group has forged a collaborative relationship with Lisa Ferrara of OrthoKinetic Technologies, LLC, one of the leading biomechanical engineers in the field of spinal implants specializing in FDA submittals, which will help to provide our clients the highest level of support when seeking FDA approval.