Bacterin's OsteoSelect PLUS Demineralized Bone Matrix Putty has received 510(k) clearance from the FDA. The product, which includes demineralized cortical chips and OsteoSelect Putty, is set for launch in the fourth quarter.
Abyrx has entered into a distribution deal with SurgiCor to help bring its hemostatic bone putty products to orthopedic and spinal surgeons across the U.S. The deal covers Abyrx's Hemasorb, Hemasorb Plus, Hemasorb Apply and AHBP.
Globus Medical has disclosed that it received a warning letter from the FDA on Sept. 26 over its MicroFuse bone-growth putty. "These deficiencies relate to the company's MicroFuse putty manufactured between Oct. 25, 2012, and Dec. 20, 2012, and mechanical testing of the company's MicroFuse putty, procedures to control environmental conditions in a clean room at the company's facility, and internal procedures for medical device reporting," the medical-device maker said. "The company is currently addressing the deficiencies cited by the FDA in the warning letter and intends to work expeditiously to address each of the outstanding issues."
Z-Medica, which has developed the QuikClot line of devices used to treat heavy bleeding, has set up a facility in Boston. The expansion gives the Wallingford, Conn.-based company closer access to research and development efforts in Massachusetts that focus on finding new ways to control bleeding, President and CEO Larry Hicks said.
The FDA has granted CryoLife conditional investigational device exemption approval for its PerClot system. The company said the device, which consists of absorbable polysaccharide granules, is designed for use as an ancillary hemostatic tool when conventional methods to control bleeding during surgery are impractical or ineffective.