Porous Biologic Scaffold

The Porous Biologic Scaffold is a resorbable bone void filler for non-structural skeletal defects in the pelvis and posterolateral spine. It comes in two versions: one with demineralized allograft bone matrix and one with biphasic ceramic granules, both contained in a porous collagen mesh. The device is combined with autograft bone as a bone graft extender and resorbs during healing, being replaced by host bone.

The device consists of a porous resorbable collagen mesh bag that is either prefilled or separately packaged with either demineralized allograft bone matrix (Version 1) or activated biphasic ceramic granules (Version 2). Both versions can be hydrated with blood, saline, or bone marrow aspirate and are available in four sizes (18×50mm, 18×100mm, 24×50mm, 24×100mm). The separate packaging format allows clinician filling and closure with absorbable suture.

ISO 10993 biocompatibility testing for permanent bone-contacting implants, ANSI/AAMI ST72 for bacterial endotoxin limits, XRD and FTIR for material characterization, and athymic rodent model for osteoinduction testing.

The Porous Biologic Scaffold demonstrates substantial equivalence because it shares the same intended use (bone void filler for non-structural defects), similar technological characteristics (resorbable scaffold with bone matrix or ceramic fill), and the same principles of operation as the predicate Mastergraft Putty. Animal testing via posterolateral spine fusion in rabbits showed substantially equivalent new bone formation and fusion rates compared to both the predicate device and iliac crest bone graft, and any technological differences do not raise new safety or effectiveness questions.