Grafton™ DBM; Grafton Plus™ DBM Paste; Magnifuse™ Bone Graft

Grafton™ DBM, Grafton Plus™ DBM Paste, and Magnifuse™ Bone Graft are human bone products containing demineralized bone matrix (DBM) intended as bone graft extenders, substitutes, and void fillers for skeletal defects in posterolateral spine, intervertebral disc space, pelvis, and extremities. These devices are absorbed and replaced by host bone during healing and must be used with FDA-cleared intervertebral fusion devices when used in spinal procedures.

Grafton™ DBM is an inert additive-containing human DBM in gel, putty, matrix, or orthoblend forms. Grafton Plus™ DBM Paste is human DBM combined with an inert additive yielding particular physical form and handling properties. Magnifuse™ Bone Graft is human DBM with surface demineralized cortical bone chips sealed in an absorbable mesh pouch, provided ready-to-use in various package sizes, and may be mixed with fluids such as bone marrow aspirate, blood, sterile water, or saline.

Not stated in this summary.

The devices and predicates share the same intended use and specific indications for intervertebral disc space, with no differences in technological characteristics that raise different safety or effectiveness questions. Material composition differences (inert additives, mesh pouch, surface demineralized chips) are addressed through prior functional animal model performance data on bone grafting materials. Robust analysis of bone grafting materials in posterolateral spine fusion studies supports the devices' performance in intervertebral body space, and the clinical analysis demonstrates the subject devices are substantially equivalent to their predicates.