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news.Osteotech has announced that the FDA has cleared its 510(k) submission for Plexur M biocomposite for use in spinal applications.
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In spinal applications, Plexur M may be used in conjunction with autograft as bone void filler. Previously, Osteotech has received the FDA clearance for Plexur M to be used in filling bony voids or gaps in the pelvis and extremities.
The Plexur technology is designed to utilize bone tissue for procedure-specific surgical applications in combination with a wide variety of polymers.
Sam Owusu-Akyaw, president and CEO of Osteotech, said: “We are very pleased to receive FDA clearance for use of Plexur M in the spine. Plexur M is the second, of what we hope to be many more, bone-polymer biocomposites developed under our proprietary Plexur® Technology.”