Pioneer(R) Surgical Technology Receives 510(k) Clearance To Market FortrOss(TM), A Next Generation Bone Void Filler

Main Category: Bones / Orthopaedics
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 05 Sep 2008 - 2:00 PDT

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Pioneer Surgical Technology, Inc. has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market FortrOss, a novel bone graft substitute utilizing the power of nanotechnology for orthopaedic applications. The FortrOss bone void filler is a scaffold for the in-growth of new bone and other connective tissues, when superior bone regeneration is required.

Pioneer's President and CEO Matthew Songer says, "There has been an incredible effort to bring this next generation bone graft substitute to the market. In a little more than a year since the 2007 acquisitions of Encelle(TM), Inc. and Angstrom(TM) Medica, the three teams have combined the nanotechnology of the nanOss material with the osteopromotive scaffold technology of the E-Matrix(TM) to create the most advanced bone void filler on the market."

The osteoconductive matrix in FortrOss utilizes Pioneer's nanOss(TM) technology and is designed to mimic the nanostructures inherent in boney tissue. Dr. Edward Ahn, Vice President of Biomaterials at Pioneer states, "Because the nanOss hydroxyapatite in FortrOss resembles the size, shape, and chemistry of native bone, boney tissue has a great affinity for nanOss and recognizes it as native tissue. This mimicry of native bone makes nanOss superior to other calcium phosphates on the market."

"The FortrOss carrier is a collagen based bioscaffold processed to provide an osteopromotive effect. Pioneer's patented E-Matrix technology provides the unique open structure for bone growth and repair," according to Dr. Ron Hill, Vice President of Research and Development at Pioneer.

The combined nanotechnology-based osteoconduction and osteopromotive E-Matrix scaffold of FortrOss positions Pioneer to impact significantly the dynamic field of bone and tissue repair. FortrOss is expected to be U.S. market released later this year.

About Pioneer Surgical Technology

Pioneer Surgical Technology, headquartered in Marquette, Michigan, is a dynamic medical device firm with a full line of cutting-edge motion preservation devices either available commercially in Europe or under clinical evaluation in the US. Pioneer's signature articulating PEEK-on-PEEK technology is the most advanced design in the industry. In addition, Pioneer's comprehensive portfolio of vertebral spacers, cervical plating systems, and MIS and Mini-Open Rod systems include familiar trade names such as Contact(TM), IJAK(R), Clarity(TM), SlimFuse(TM), and Quantum(R).

Pioneer entered the orthobiologics market with two acquisitions in 2007. Encelle(TM), Inc., developed E-Matrix(TM) for tissue regeneration. Angstrom(TM) Medica, Inc. is the first company to obtain FDA approval for a nanotechnology device -- nanOss(TM) -- a hydroxyapatite bone void filler.

Pioneer's three divisions ... Orthopedics, Spine, and Biologics ... produce state of the art, cost-effective solutions for surgical procedures that have proven difficult or problematic for both surgeons and patients.

Pioneer Surgical Technology, Inc.
http://www.pioneersurgical.com