NovaBone Putty Wins FDA Clearance for Interbody Fusion Use

The U.S. Food and Drug Administration (FDA) has cleared NovaBone Products’ bioactive synthetic bone graft for use in the intervertebral disc space, thus allowing NovaBone Putty to be employed in the intervertebral disc space with approved interbody fusion devices.

Known for its bioactive and osteostimulative properties, NovaBone Putty offers a unique formulation of calcium sodium phosphosilicate (Bioglass) particulate mixed with a synthetic binder. This composition facilitates bone void filling and is gradually replaced by new bone tissue during the natural healing process.

“FDA clearance for this interbody indication highlights our commitment to expanding the applications of NovaBone Putty,” NovaBone CEO Carolin Archibald said. “Surgeons have an option for interbody fusion that leverages our advanced bioactive technology to help foster natural bone growth while ensuring ease of handling in critical applications.”

Using previously cleared reference devices, NovaBone substantiated the putty’s sterility, biocompatibility, and shelf life while also ensuring compliance with the FDA’s Class II Special Controls for Resorbable Calcium Salt Bone Void Filler Devices.

This FDA clearance builds on NovaBone’s mission to develop bioactive bone graft solutions that support natural bone healing and demonstrate clinical reliability. NovaBone Putty has a strong record of effectiveness in millions of clinical applications globally, enhancing surgical outcomes and contributing to better patient care.

A Halma company, Florida-based NovaBone is privately held. The company developed the first bioactive synthetic bone graft offered to the orthopedic community and has been at the forefront of bioactive glass bone graft devices. It has developed numerous formulations and delivery systems of its patented, bioactive technology platform that results in accelerated bone growth. In total, the firm’s exclusively formulated bone graft substitute has been used to repair osseous defects throughout the skeletal system for more than a decade and used in over 1 million clinical applications.