NanoBone® SBX Putty ; NanoBone® QD

NanoBone® SBX Putty and NanoBone® QD are bone void fillers consisting of nanocrystalline hydroxyapatite granules embedded in an aqueous gel. They are used to fill bony voids or gaps in the skeletal system (extremities, spine, intervertebral disc space, pelvis) caused by surgery or trauma. The material resorbs and is replaced with bone during healing.

Both devices consist of phase-pure non-sintered nanocrystalline osteoconductive hydroxyapatite embedded in a highly porous silica gel matrix with interconnected nano, micro, and macro pores mimicking human cancellous bone. The devices differ only in packaging: SBX Putty uses a sterile applicator with attached plunger, while QD uses a sterile cartridge with separate plunger. Neither sets in-situ after implantation.

Not stated in this summary.

The submission expands indications to include intervertebral disc space, where the predicate devices are already cleared. Although material composition differs from predicates, these differences do not raise different safety and effectiveness questions because prior animal model studies in posterolateral spine fusion support performance in intervertebral applications. The subject devices were previously cleared under K190110 with established sterility, shelf-life, biocompatibility, and performance data meeting FDA's Class II Special Controls guidance for resorbable calcium salt bone void fillers.