logo
Share SHARE
FONT-SIZE Plus   Neg

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.

by RTT Staff Writer

For comments and feedback: editorial@rttnews.com

Business News

Quick Facts

Editors Pick
Online retail giant Amazon.com Inc. (AMZN) is reportedly in talks to buy luxury online fashion retailer Net-a-Porter. The news of acquisition was first reported by Women's Wear Daily, which said the deal would be completed for about 2 billion euros, indicating the biggest acquisition yet by Amazon.... Tim Cook, the CEO of tech giant Apple Inc., in an interview said he intends to give away all his wealth to charity. Cook, in an interview to Fortune, said he plans to donate all his wealth to philanthropic projects after paying for his 10-year old nephew's college education. According to Fortune,... Is it a 'personal life crisis' that led the Germanwings' co-pilot Andreas Lubitz to deliberately lowering the plane carrying 149 people to French Alps mountain? Police is investigating to find evidences to prove this suggestion.
comments powered by Disqus
Follow RTT