08.25.15
Bacterin International Inc. has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its Osteoselect Plus demineralized bone matrix (DBM) putty.
Osteoselect Plus is a next-generation DBM putty composed of Osteoselect putty with the addition of demineralized cortical chips. The product provides an additional sterile grafting solution for customers. Osteoselect Plus will also eliminate the need to mix bone chips and DBM putty intra-operatively, saving time and reducing graft variability.
“We are very pleased with the FDA’s decision to approve Osteoselect Plus for marketing and distribution,” said Chief Scientific Officer Gregory Juda, Ph.D. “We developed this next generation bone graft material in response to surgeon demand using design input from surgeon customers. Because of their involvement in the development process, we are confident that osteoselect plus will be successfully received in the market and will serve to make our comprehensive product portfolio even stronger.”
With this notice and clearance from the FDA, Xtant Medical is prepared to launch Osteoselect Plus to customers in the fourth quarter of this year. The company will work with its primary group purchasing organization and integrated delivery network customers to add this product to current contracts, making it available immediately upon product launch. This is the first 510(k) approval for Bacterin International since acquiring X-spine Systems and rebranding as Xtant Medical Inc. earlier this summer.
According to company officials, this latest launch is the first of many planned product releases as management focuses on rounding out the combined product portfolio.
"This new product will help drive the company’s growth and provides an opportunity for increased market share," officials noted in a press release.
Osteoselect Plus is a next-generation DBM putty composed of Osteoselect putty with the addition of demineralized cortical chips. The product provides an additional sterile grafting solution for customers. Osteoselect Plus will also eliminate the need to mix bone chips and DBM putty intra-operatively, saving time and reducing graft variability.
“We are very pleased with the FDA’s decision to approve Osteoselect Plus for marketing and distribution,” said Chief Scientific Officer Gregory Juda, Ph.D. “We developed this next generation bone graft material in response to surgeon demand using design input from surgeon customers. Because of their involvement in the development process, we are confident that osteoselect plus will be successfully received in the market and will serve to make our comprehensive product portfolio even stronger.”
With this notice and clearance from the FDA, Xtant Medical is prepared to launch Osteoselect Plus to customers in the fourth quarter of this year. The company will work with its primary group purchasing organization and integrated delivery network customers to add this product to current contracts, making it available immediately upon product launch. This is the first 510(k) approval for Bacterin International since acquiring X-spine Systems and rebranding as Xtant Medical Inc. earlier this summer.
According to company officials, this latest launch is the first of many planned product releases as management focuses on rounding out the combined product portfolio.
"This new product will help drive the company’s growth and provides an opportunity for increased market share," officials noted in a press release.