FDA clears Baxter’s prepackaged synthetic bone filler graft

Baxter International received an FDA clearance for a new formulation of its Actifuse synthetic bone graft substitute, now deliverable via a prepackaged syringe that requires no mixing or preparation.

For use in a variety of orthopedic surgeries, Actifuse Flow uses the same silicate-substitution technology to help accelerate bone formation after being placed in small voids or gaps in the skeletal system.

The latest addition to Baxter’s osteobiologics portfolio, it is designed to maintain a flowable consistency throughout surgery. As the graft is resorbed, it is replaced by the patient’s own bone during the healing process.

In a statement, Baxter said it expects Actifuse Flow to be used in open and less-invasive surgeries in the pelvis, extremities and posterolateral spine, and described it as being well-suited to fill small bone defects and complex geometries.

The Deerfield, Illinois-based company expects Actifuse Flow to be available to U.S. customers by the end of the year, in 5 mL, 3 mL and 1.5 mL sizes. The graft substitute is intended only as a filler for gaps and voids, and not where it will serve as structural or load-bearing support.

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