Etex Corp.'s bone sub materials get another 510(k)

April 27, 2009 by MassDevice staff

The Food & Drug Administration cleared Etex Corp.'s orthopedic putty for use in small-bone repairs.

The Cambridge biotech said the federal watchdog agency gave the nod to 1cc and 5cc sizes of its Beta-bsm injectable paste and Gamma-bsm moldable putty, on top of existing clearances for the 5cc and 10cc sizes.

The bone substitute materials are used to make osteo-conductive scaffolds that ape the nanocrystalline structure of human bone. The smaller sizes were developed for hand and foot/ankle surgeries. The products are used to fill voids in bone that the bone doesn't depend on for stability.

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