NovaBone Putty Receives FDA Clearance for Interbody Fusion Applications
核心洞察
NovaBone Putty (搜索) has received FDA clearance for use in interbody fusion procedures, expanding its application in spinal and orthopedic surgeries.
The bioactive synthetic bone graft is formulated with Calcium Sodium Phosphosilicate (Bioglass) to facilitate bone void filling and natural bone regeneration.
This clearance underscores NovaBone (搜索)'s commitment to providing innovative solutions that meet high safety and performance standards in bone healing.
NovaBone (搜索) Products has announced FDA clearance for NovaBone Putty (搜索), a bioactive synthetic bone graft, for use in interbody fusion procedures. This clearance expands the applications of NovaBone Putty to support a broader range of spinal and orthopedic surgical needs.
The FDA clearance, granted under K242299, allows NovaBone Putty (搜索) to be used in the intervertebral disc space alongside FDA-cleared interbody fusion devices. NovaBone Putty is composed 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.
Executive Commentary
Carolin Archibald, CEO of NovaBone (搜索), stated, "FDA clearance for this interbody indication highlights our commitment to expanding the applications of NovaBone Putty (搜索). Surgeons now 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."
Clinical Use and Safety
The recent clearance underscores NovaBone (搜索)’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.
About NovaBone Products
NovaBone (搜索), a Halma company, has been developing bioactive glass bone graft devices since 2002. Their 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.