"NovaBone Secures FDA Clearance for Expanded Indications of Putty in Interbody Fusion Applications"
NovaBone Products, a leader in synthetic bone graft solutions, has announced its latest milestone: FDA clearance for its bioactive synthetic bone graft, NovaBone Putty, now expanded for use in the intervertebral disc space. This clearance marks an important addition to NovaBone’s existing portfolio, extending the use of NovaBone Putty for interbody fusion procedures to support a broader range of spinal and orthopedic surgical needs.
The FDA clearance, granted under K242299, allows NovaBone Putty to be used in the intervertebral disc space alongside FDA-cleared 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.
Carolin Archibald, CEO of NovaBone, commented, “FDA clearance for this interbody indication highlights our commitment to expanding the applications of NovaBone Putty. Surgeons have a trusted option for interbody fusion that leverages our advanced bioactive technology to help foster natural bone growth while ensuring ease of handling in critical applications.”
The recent clearance underscores NovaBone’s dedication to providing innovative solutions that align with the highest safety and performance standards. Using reference devices previously cleared under K240404 and K082672, NovaBone substantiated the device’s sterility, biocompatibility, and robust 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 history of pioneering bioactive bone graft solutions that support natural bone healing and demonstrate clinical reliability. Used in millions of clinical applications globally, NovaBone Putty has a strong record of effectiveness, enhancing surgical outcomes and contributing to better patient care.
For more information about the newly FDA-cleared NovaBone Putty for interbody fusion applications, please contact NovaBone [Click Here]
About NovaBone
NovaBone, a Halma company, is privately held and based in Florida since 2002. NovaBone developed the first bioactive synthetic bone graft offered to the orthopedic community and has long 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, their exclusively formulated bone graft substitute has been used for the repair of osseous defects throughout the skeletal system for over a decade and used in over a million clinical applications with unparalleled success validating the safety and efficacy of NovaBone's technology.
