OsteoFlo HydroFiber

OsteoFlo HydroFiber is a sterile, resorbable bone void filler made of calcium phosphate particles bound together. It is mixed with aqueous solution (saline, blood, autograft, or bone marrow) before use and packed into bone defects in the extremities, pelvis, spine, or intervertebral disc space. The device is gradually resorbed and replaced by new bone during healing and may be used alone or combined with autograft as a bone graft extender.

Both the subject device and primary predicate (MASTERGRAFT Putty) are sterile, dry solids mixed with solution at use to form moldable putty. They share the same osteoconductive mechanism: a resorbed binder exposes calcium phosphate particles that act as scaffold for bone formation. The devices differ in package formats and material composition, but performance testing shows these differences do not affect safety or effectiveness.

ISO 10993-1:2018 (biocompatibility); ISO 11137-1:2006 and ISO 11137-2:2013 (sterilization validation); ISO 11607-1:2009 and ISO 11607-2:2006 (packaging validation); ASTM 1980-16 (shelf-life); AAMI ST72 (endotoxin); material characterization via x-ray diffraction, particle size analysis, and porosity assessment; in vivo rabbit metaphyseal defect model; pyrogenicity testing.

The device has identical intended use to MASTERGRAFT Putty and functions through the same osteoconductive mechanism. Although material composition and packaging differ, non-clinical testing demonstrates these differences raise no new safety or effectiveness questions. The testing shows equivalent performance in biocompatibility, sterilization, packaging integrity, shelf-life stability, and in vivo bone formation, establishing that the device performs comparably to the predicate.