RTI Biologics® Receives 510(k) Clearance for Porcine Dermis Implant
ALACHUA, Fla. -- March 13, 2013
RTI Biologics Inc. (RTI) (Nasdaq:RTIX), a leading provider of orthopedic and
other biologic implants, is pleased to announce that the company has received
510(k) clearance from the U.S. Food and Drug Administration (FDA) for its
porcine dermis implant. The implant is intended for use in soft tissue repair
procedures such as hernia repair.
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
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.”
About RTI Biologics Inc.
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.
RTI’s innovations continuously raise the bar of science and safety for
biologics – from being the first company to offer precision-tooled bone
implants and assembled technology to maximize each gift of donation, to
inventing validated sterilization processes that include viral inactivation
steps. These processes — BioCleanse®, Tutoplast® and Cancelle™ SP DBM — have a
combined record of more than four million implants distributed with zero
incidence of implant-associated infection. These processes have been validated
by tissue type to inactivate or remove viruses, bacteria, fungi and spores
from the tissue while maintaining biocompatibility and functionality.
RTI’s worldwide corporate headquarters are located in Alachua, Fla., with
international locations in Germany and France. The company is accredited by
the American Association of Tissue Banks in the United States and is a member
RTI Biologics Inc.
Jenny Highlander, APR, 386-418-8888
Manager, Corporate Communications
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