November 12, 2024 – NovaBone Merchandise, a frontrunner in artificial bone graft options, has introduced its newest milestone: FDA clearance for its bioactive artificial bone graft, NovaBone Putty, now expanded to be used within the intervertebral disc area. This clearance marks an necessary addition to NovaBone’s present portfolio, extending the usage of NovaBone Putty for interbody fusion procedures to help a broader vary of spinal and orthopedic surgical wants.
The FDA clearance, granted below K242299, permits NovaBone Putty for use within the intervertebral disc area alongside FDA-cleared interbody fusion units. Recognized for its bioactive and osteostimulative properties, NovaBone Putty gives a singular formulation of Calcium Sodium Phosphosilicate (Bioglass) particulate blended with an artificial binder. This composition facilitates bone void filling and is regularly changed by new bone tissue throughout the pure therapeutic course of.
Carolin Archibald, CEO of NovaBone, commented, “FDA clearance for this interbody indication highlights our dedication to increasing the purposes of NovaBone Putty. Surgeons have a trusted possibility for interbody fusion that leverages our superior bioactive know-how to assist foster pure bone progress whereas guaranteeing ease of dealing with in essential purposes.”
The latest clearance underscores NovaBone’s dedication to offering revolutionary options that align with the best security and efficiency requirements. Utilizing reference units beforehand cleared below K240404 and K082672, NovaBone substantiated the machine’s sterility, biocompatibility, and strong shelf-life whereas additionally guaranteeing compliance with the FDA’s Class II Particular Controls for Resorbable Calcium Salt Bone Void Filler Gadgets.
This FDA clearance builds on NovaBone’s historical past of pioneering bioactive bone graft options that help pure bone therapeutic and show medical reliability. Utilized in thousands and thousands of medical purposes globally, NovaBone Putty has a robust report of effectiveness, enhancing surgical outcomes and contributing to raised affected person care.
For extra details about the newly FDA-cleared NovaBone Putty for interbody fusion purposes, please contact NovaBone [Click Here]
About NovaBone
NovaBone, a Halma firm, is privately held and primarily based in Florida since 2002. NovaBone developed the primary bioactive artificial bone graft provided to the orthopedic group and has lengthy been on the forefront of bioactive glass bone graft units. It has developed quite a few formulations and supply techniques of its patented, bioactive know-how platform that ends in accelerated bone progress. In whole, their completely formulated bone graft substitute has been used for the restore of osseous defects all through the skeletal system for over a decade and utilized in over 1,000,000 medical purposes with unparalleled success validating the protection and efficacy of NovaBone’s know-how.
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