RTI Biologics® Receives 510(k) Clearance for Porcine Dermis Implant March 13, 2013
RTI Biologics Inc., is a long standing provider of orthopedic and other biologic implants. The company has now announced that it has received FDA 510(k) clearance for its porcine dermis implant. The implant is intended for use in soft tissue repair procedures such as hernia repair.
RTI Biologics Inc. is a leading provider of sterile biologic implants for surgeries around the world with a commitment to advancing science, safety and innovation. RTI prepares human donated tissue and xenograft tissue for transplantation through extensive testing and screening, precision shaping and using proprietary, validated processes. These allograft and xenograft implants are used in orthopedic, dental and other specialty surgeries.
Stored hydrated and ready-to-use, the porcine dermis implant is comprised of non-crosslinked porcine dermis, designed to act as a scaffold that allows for neovascularization and reincorporation with the patient’s own tissue. The implants will be made available in various shapes and sizes.
The implant is sterilized through the Tutoplast® Tissue Sterilization Process, which is 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 implants will 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.
“We are extremely pleased to have received 510(k) clearance in the first quarter of the year,” said Brian K. Hutchison, president and chief executive officer. “Our newly developed surgical specialties direct distribution team is eager to add the porcine dermis implant to their current biologics portfolio, and this clearance supports our schedule for a full launch later this year.”
Source: RTI Biologics, Inc., Business Wire