Millenium Biologix receives 510(k) approval for first Microporous Skelite product

New York, Nov. 22 - Millenium Biologix Corp. said it received class 2 510(k) clearance from the Food and Drug Administration to market and sell its Microporous Skelite 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 Timothy Smith, president and chief operating officer of Millenium, in a news release.

The Microporous Skelite Resorbable Cement Restrictor is a hollow, rounded rectangular device with textured surfaces on two opposing sides. It is 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.

Millenium says the device allows the development of specialized synthetic bone graft implants with greater compressive strength and impact resistance.

Millenium is a Kingston, Ont., biomedical company working on implantable medical devices and skeletal tissue regeneration products for targeted orthopedic uses.

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