Millenium Biologix Announces FDA 510(k) Clearance for First Device Based on Microporous Skelite(TM) Technology

23-Nov-2005

Millenium Biologix Corporation announced that it has received a Class II 510(k) clearance from the U.S. food and Drug Administration ("FDA") to market and sell its Microporous Skelite(TM) Resorbable Cement Restrictor product in the United States.

"This clearance allows us to bring our first product to market based on our Microporous Skelite Technology," said Dr. Timothy Smith, President and COO of Millenium. "This Microporous Skelite Technology enables the development of specialized synthetic bone graft implants with greater compressive strength and impact resistance. With these enhanced properties, the range of orthopedic applications for our Skelite technology has been broadened to include those where higher stresses are involved."

The Microporous Skelite Resorbable Cement Restrictor is a hollow, rounded rectangular device with textured surfaces on two opposing sides and is available in various sizes. It is packaged as a sterile, single use implantable device that is intended to be used as a cement restrictor in orthopedic surgeries such as those involving the femoral and tibial canals in hip stem and total knee replacements.

https://www.bionity.com/en/news/50416/millenium-biologix-announces-fda-510-k-clearance-for-first-device-based-on-microporous-skelite-tm-technology.html