Porous Biologic Scaffold

The Porous Biologic Scaffold is a resorbable bone void filler intended for use in bone defects of the pelvis, intervertebral disc space, and posterolateral spine. It comes in two versions: one with demineralized allograft bone matrix in a collagen mesh, and another with activated biphasic ceramic granules in a collagen mesh. Both are combined with autograft bone prior to implantation and are resorbed and replaced with host bone during healing.

Version 1 uses a porous collagen mesh with human demineralized allograft bone matrix (available prefilled or separately packaged). Version 2 uses a porous resorbable collagen mesh with activated biphasic ceramic granules (also available prefilled or separately packaged). Both can be hydrated with blood, saline, or bone marrow aspirate. The devices differ in material composition from predicates but maintain the same collagen mesh structure and intended bone void filler function.

Not stated in this summary.

The subject device has the same intended use and indications as the predicate devices (Attrax Putty and Fibergraft BG Putty) for bone void filling in spinal and pelvic applications. Although material composition differs (demineralized allograft or biphasic ceramics versus the predicates' materials), these differences do not raise different safety and effectiveness questions because the effects were addressed through prior functional animal model performance data. Performance is further supported by reference to the previously cleared K240765 device, leveraging sterility, shelf-life, biocompatibility, and bench performance data per FDA's Class II Special Controls Guidance.