EATONTOWN, N.J., April 25 /PRNewswire-FirstCall/ -- Osteotech, Inc. (Nasdaq: OSTE), a leader in the emerging field of biologic solutions for regenerative medicine, announced today that the United States Food and Drug Administration ("FDA") has cleared its 510(k) submission for the Plexur P(TM) Biocomposite for use in spinal applications as a bone void filler and as a bone graft extender. Previously, Osteotech received FDA clearance for Plexur P(TM) for use in filling bony voids of the pelvis and extremities.
Sam Owusu-Akyaw, Osteotech's President and Chief Executive Officer, stated, "We are very pleased to receive FDA clearance for the use of our Plexur P(TM) product in the spine. We continue to receive many favorable comments from orthopedic surgeons about the efficacy of Plexur P(TM) and we will immediately offer our Plexur P(TM) product to spine surgeons supported by the clinical information and experience we have gained over the last year. Our proprietary Plexur(R) Technology continues to be one of the keys to our product pipeline and future growth initiatives."
To date, the Plexur P(TM) Biocomposite has been used by a variety of surgeons in tibial plateau fractures, tibial osteotomies and a variety of foot and ankle procedures, and can now be used in the spine. Our Plexur P(TM) product can be combined with our proprietary Grafton(R) DBM, local bone or our new Kinesis(TM) BMAC(TM) cellular system. Plexur P(TM) is available as granules, cylinders, blocks, wedges and sheets. For more information about the Plexur P(TM) Biocomposite, please go to our websites at http://www.plexur.com or http://www.osteotech.com.
|SOURCE Osteotech, Inc.|
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