New Orthopaedic Material Market-Ready
Plexur M biocomposite, a bone polymer manufactured by Osteotech, was cleared by the U.S. Food and Drug Administration for marketing. One indication for the polymer is as a bone void filler for spinal applications.
For use in spine surgeries, the material is to be utilized with an autograft as a bone filler. The system was previously approved by the FDA for use in the pelvis or extremities to fill gaps or voids in bone.
This is the second bone-polymer biocomposite released by the company. Osteotech’s Plexur P was already approved by the FDA. That material is indicated for treatment completed as part of reconstructive surgeries or during trauma. The company’s Plexur is crafted from bone tissue which is combined with an array of polymers.
The product will undergo a preliminary limited launch to allow the company continued data collection. Information gained during that time will be leveraged to develop technique guidelines and marketing materials.
July 31, 2008 Related topics: Product Approval & Certification, Orthopedic