BioMimetic Therapeutics Inc announced that the US Food & Drug Administration (FDA) has accepted for review its Premarket Approval (PMA) application for Augment Bone Graft for use in foot and ankle fusions in the US. The FDA has now filed the application and begun the comprehensive review of the clinical module, the company added.

Biocomposites has launched geneX ds, a dual syringe mixing and minimally invasive delivery system containing geneX, the unique resorbable bone graft material with a negative surface charge. The powder and liquid components of geneX are provided pre-packed in separate syringes. The syringes connect together and allow a faster, simpler and cleaner way for mixing geneX. The resulting setting paste can then be delivered through a 3.15″ dispenser (included).

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DePuy Mitek, Inc. has announced the launch of the HEALIX™ BR Dual Threaded Anchor System, the first suture anchor for arthroscopic rotator cuff repair made with the company’s proprietary BIOCRYL® RAPIDE™ biocomposite material, shown in pre-clinical trials to resorb and promote bone formation within the implant profile2. BIOCRYL RAPIDE has become an important technology platform in orthopedics sports medicine. The biocomposite material, exclusive to DePuy Mitek products, has more than four years of clinical success in more than 100,000 patients. BIOCRYL RAPIDE is currently used in the MILAGRO Bioreplaceable Interference Screw for anterior cruciate ligament (ACL) repair.

The FDA has cleared Osteotech Inc.’s Plexur P biocomposite for use in spinal applications as a bone void filler and graft extender. Osteotech has already received FDA clearance for Plexur P for use in filling bony voids of the pelvis and extremities. The biocomposite has been used in tibial plateau fractures, tibial osteotomies and foot and ankle procedures. The company aims to immediately offer our Plexur P(TM) product to spine surgeons.

Osteotech Inc. has received FDA approval for its 510(k) submission for its Plexur M(TM) Biocomposite. Plexur M is intended for use in filling bony voids or gaps of the skeletal system that are not intrinsic to the stability of the bony structure. During the healing process, Plexur M is remodeled and replaced by host bone. When heated, Plexur M becomes moldable and pliable, which allows surgeons various options for use during surgery. During the cooling process, Plexur M hardens, providing a versatile porous scaffold to help in regeneration of damaged and diseased bones.

Osteotech’s president and CEO Sam Owusu-Akyaw has indicated that the company intends to file an additional submission for the use of this product in spinal applications during the second quarter of the year.