Smith & Nephew Gets 510(k) Clearance for Wear Resistant Knee Replacement Technology

Smith & Nephew has just received 510(k) clearance from the FDA for claims related to their VERILAST technology, a combination of transformed metal alloy with highly cross-linked polyethylene designed to minimize wear. Most total knee replacements consist of a cobalt-chrome metal alloy femoral component, while the tibial component is made from ultra-high molecular weight polyethylene (UHMWPE) or highly cross-linked polyethylene (a plastic). These implants usually fail due to thinning of the plastic component from wear and friction, which then requires a revision surgery to replace the implant. If one can minimize wear then, theoretically, the implants will last much longer.
Smith & Nephew’s VERILAST technology consists of a femoral component made from their OXINIUM material: a hypo-allergenic zirconium metal alloy with a transformed ceramic surface. The advantages of using a ceramic material as a surface are the resistance to scratching and the significantly reduced wear, which Smith & Nephew demonstrated in a laboratory trial in which their devices were able to withstand the equivalent of 30 years of wear. In addition, the device contains no detectable nickel, which is the element that most commonly causes allergic reactions in patients with implanted orthopedic devices.
Read the press release here…
Link: VERILAST Technology…
Product page: The LEGION Total Knee System…