ETEX wins another bone putty nod from the FDA

March 9, 2010 by MassDevice staff

ETEX Corp. won 510(k) clearance from the Food & Drug Administration for its CarriGen bone graft substitute and wasted no time getting the product on the market.

The Cambridge, Mass.-based biotech firm said the nanocrystalline calcium phosphate bone void filler is available for immediate sale through its independent sales force, according to a press release.

The FDA cleared CarriGen to correct defects in the pelvis, extremities and spine, including posterolateral spine fusion, according to the release. It's a viscous putty made by mixing with saline solution or blood and can be injected or molded into a defect, designed to set into a porous scaffold to allow natural bone to fill in around the scaffold.

It's the latest 510(k) clearance for one of ETEX's bone putty products. In April 2009 the FDA cleared 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.

In January, the company inked a distribution deal with an OrthoPediatrics Corp. to sell its bone putties into the pediatric market in the U.S. and Canada.

Permalink