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BioSphere MIS Putty is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. BioSphere MIS Putty is indicated to be gently packed into bony voids or gaps of the skeletal system as a bone void filler in the extremities and pelvis, and as a bone graft extender in the posterolateral spine. These defects may be surgically created osseous defects created from traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced with bone during the healing process.

BioSphere MIS Putty ("BioSphere MIS") is an osteoconductive, bioactive bone void filler that, like its predicate device, is composed primarily of medical-grade 4555 bioactive glass particles. The composition and formula of this material is unchanged and is identical to that used in the BioSphere Putty predicate. The bioactive glass is mixed with an inert, moldable carrier using the exact same composition and formula as used in the predicate device. The only difference between the two devices is that BioSphere MIS Putty is supplied in a prefilled cannula with a delivery gun to aid with placement into certain types of bony voids that are otherwise difficult to reach. The manner in which the device is delivered to the target site does not play any role in the putty achieving its intended clinical purpose (i.e., supporting bone regeneration). Upon implantation of BioSphere MIS Putty into the target site, the carrier is absorbed by the site and the remaining bioactive glass particles provide an osteoconductive surface for bone formation. The bioactive glass particles are supplied in a spherical form, and the natural packing of the spheres creates 3-dimensional, interconnected porosity that allows for bone regeneration throughout the defect site. This is the same mechanism of action as with the predicate. In the posterolateral spine, BioSphere MIS Putty can be combined with autograff as a bone graft extender in the same manner as the predicate BioSphere Putty.

BioSphere Putty is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. BioSphere Putty is indicated to be gently packed into bony voids or gaps of the skeletal system (i.e. the extremities and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced with bone during the healing process.

BioSphere Putty is an osteoconductive, bioactive bone void filler that, like its predicate device (NovaBone), is composed of 4555 bioactive glass particles. In BioSphere Putty, the bioactive glass is mixed with an inert, moldable carrier that aids in placement of the product into bony voids. Upon implantation, the carrier is absorbed by the site and the remaining bioactive glass particles provide an osteoconductive surface for bone formation. The bioactive glass particles are provided in a spherical form, and the natural packing of the spheres creates 3-dimensional, interconnected porosity that allows for bone regeneration throughout the defect site.