Quick Facts
FONT-SIZE Plus   Neg
Share SHARE

RTI Biologics Gets 510(k) Clearance From FDA For Porcine Dermis Implant

RTI Biologics Inc. (RTIX: Quote), a provider of orthopedic and other biologic implants, said has received 510(k) clearance from the U.S. Food and Drug Administration or FDA for its porcine dermis implant. The implant is planned for use in soft tissue repair procedures such as hernia repair.

Stored hydrated and ready-to-use, the porcine dermis implant consists of non-crosslinked porcine dermis, designed to act as a scaffold that allows for neovascularization and reincorporation with the patient's own tissue.

The implant, would be made available in various shapes and sizes, is sterilized through the Tutoplast Tissue Sterilization Process, a chemical process to sterilize and preserve tissue for implantation. Since the first clinical use in 1971, there has been zero incidence of implant-associated infection from millions of implants sterilized through the process.

The company added that the implants would be processed at RTI's facility in Neunkirchen, Germany for commercial distribution in the U.S. later this year. The facility has been validated for processing and has begun production of the implants.

Click here to receive FREE breaking news email alerts for RTI Surgical Inc. and others in your portfolio

by RTT Staff Writer

For comments and feedback: editorial@rttnews.com

Business News

Editors Pick
Beverages giant Coca-Cola Co. reported Tuesday a profit for the third quarter that decreased 14 percent from last year, despite higher worldwide volumes, reflecting a revenue drop. Adjusted earnings per share matched analysts' expectations, even as quarterly revenues missed their estimates. Following the announcement, the company's shares are trading more than five percent lower in early deals. Apple Inc. said Monday that its fourth quarter profit rose 13% from last year, driven by strong sales of its iPhones and Mac computers. The company's quarterly earnings per share also came in above analysts' expectations as did its quarterly sales. At the same time, the company gave an upbeat revenue forecast for the current quarter, which includes the all important holiday season. Programmable chipmaker Xilinx Inc. (XLNX) said Thursday after the markets closed that its second quarter profit rose 21% from last year, helped by higher revenue and better cost control. The company's quarterly earnings per share also came in above analysts' expectations as did its quarterly revenue....
comments powered by Disqus
FREE Newsletters, Analysis & Alerts

 

Stay informed with our FREE daily Newsletters and real-time breaking News Alerts. Sign up to receive the latest information on business news, health, technology, biotech, market analysis, currency trading and more.