OsteoFlo HydroFiber

OsteoFlo HydroFiber is a resorbable bone void filler made of calcium phosphate, bioglass, and a synthetic polymer binder. It is intended to fill osseous defects in non-load-bearing skeletal sites (pelvis, posterolateral spine, intervertebral disc space) and can be used alone or combined with autograft as a bone graft extender. The device is supplied sterile and dry, requires mixing with aqueous solution before use, and is gradually resorbed and replaced with host bone during healing.

OsteoFlo HydroFiber and its predicates are all resorbable calcium salt bone void fillers with a binder that resorbs to expose calcium phosphate-based particles acting as an osteoconductive scaffold. The subject device's material composition differs from the predicates, but contains the same functional components—calcium phosphate particles and a resorbable binder—and is packaged and sterilized using similar methods to the predicate devices.

Biocompatibility per ISO 10993-1:2018; sterilization validation per ISO 11137-1:2006 and ISO 11137-2:2013; packaging validation per ISO 11607-1:2009 and ISO 11607-2:2006; shelf-life testing per ASTM 1980-16; and in vivo evaluation in a lapine posterolateral fusion model.

Although the subject device's material composition varies from the predicates, biocompatibility testing, material characterization, and in vivo animal study demonstrate that these compositional differences do not raise different safety or effectiveness questions. The device shares the same indications for use, similar design principles (resorbable binder exposing calcium phosphate scaffold), and comparable performance characteristics to the predicate devices, establishing substantial equivalence.