 |
Caution: Investigational device, limited by Federal (or United States) law to investigational use. The FSU device is currently not available in the United States. Information is presented on the website for general education. Flexuspine's FSU (Functional Spinal Unit) Total Spinal Segment Replacement is designed to provide an alternative to fusion by reestablishing mobility to an affected segment of the lumbar spine. It is a comprehensive device comprised of an interbody disc component (Core) and posterior dynamic resistance component (Dampener) that was designed as a system to replace the natural kinematics of the motion segment. FSU Wear Testing and Particulate Animal Study The motion of any joint, human or man-made, will experience the effects of wear, which can produce microscopic particles. All arthroplasty devices exhibit wear, and, in the vast majority of cases, the body can manage the resultant particles. But depending on their size and amount, the body's cellular response to these foreign elements can sometimes lead to the destruction of surrounding bone leading to possible device loosening.1 Wear testing of the Flexuspine FSU was performed to characterize the volumetric wear potential of the FSU system. Testing in animals was also performed to evaluate the physiological response to wear debris comparable to that produced by the FSU system in vitro. The FSU Core CoCr metal-on-metal articulation demonstrated wear comparable to metal-on-metal total disc replacements.2 The FSU silicone dampeners also showed minimal wear and sufficient durability under clincally relevant motions.
Bushelow M, Walker J, Coppes J, Hinter M, Nechtow W, Kaddick C, "Comparison of Wear Rates: Metal/UHMWPE and Metal-on-Metal Total Disc Arthroplasty," Spine J, 2007, 7(5S): 97S-98S. 1 Jacobs, "Wear Particles" JBJS (2007) 88:99-102 2 Maverick and ProDisc L Total Disc Replacement Devices |
