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Porous Biologic Scaffold is a bone void filler intended for use in osseous defects of the skeletal system that are not intrinsic to the stability of the bony structure. These defects may be surgically created or the result of traumatic injury to the bone. Porous Biologic Scaffold is indicated to be packed gently into bony voids or gaps of the pelvis, intervertebral disc space, and posterolateral spine and is used combined with autograft as a bone graft extender. The device is resorbed and replaced with host bone during the healing process. When used in intervertebral body fusion procedures, Porous Biologic Scaffold must be used with an intervertebral body fusion device cleared by FDA for use with a bone void filler.

Porous Biologic Scaffold is a resorbable bone void filler that is available in two versions: Version 1 is comprised of a porous collagen mesh that is either prefilled or separately packaged with human demineralized allograft bone matrix. In the prefilled format, the demineralized bone matrix is completely enclosed inside the collagen mesh. In the separately packaged format, an open-ended collagen mesh bag is supplied with separately packaged demineralized bone matrix and is filled and sewn closed with absorbable suture by the clinician. Version 1 of the Porous Biologic Scaffold may be hydrated with blood, saline, or bone marrow aspirate, and is combined with autograft bone prior to implantation. Version 2 is comprised of a porous resorbable collagen mesh bag either prefilled or separately packaged with activated biphasic ceramic granules. In the prefilled format, the biphasic granules are completely enclosed inside the collagen mesh. In the separately packaged format, an openended collagen mesh bag is supplied with separately packaged biphasic granules and is filled and sewn closed with absorbable suture by the clinician. Version 2 of the Porous Biologic Scaffold may be hydrated with blood, saline, or bone marrow aspirate, and is combined with autograft bone prior to implantation. Both formats of the Porous Biologic Scaffold are supplied terminally sterile and are available in sizes of 18 x 50 mm, 18 x 100 mm, 24 x 50 mm, and 24 x 100 mm.

Synthetic Bone Putty is a bone void filler intended for use in osseous defects of the skeletal system that are not intrinsic to the stability of the bony structure. These defects may be surgically created or the result of traumatic injury to the bone. Synthetic Bone Putty is indicated to be packed gently into bony voids or gaps of the pelvis, posterolateral spine, or intervertebral disc space, and may be used either standalone or in combination with autograft extender. The device is resorbed and replaced with host bone during the healing process. When used in intervertebral body fusion procedures, Synthetic Bone Putty must be used with an intervertebral body fusion device cleared by FDA for use with a bone void filler.

Synthetic Bone Putty is composed of biphasic ceramic granules in an alkylene oxide polymer carrier, and it is identical to the device cleared in K221644. This submission expands the device's indication to include use in the intervertebral spine.

Synthetic Bone Putty is a bone void filler intended for use in bony voids or gaps of the skeletal system that are not intrinsic to the stability of the bony structure. These defects may be surgically created or a result of traumatic injury to the bone. Synthetic Bone Putty is indicated to be packed gently into bony voids or gaps of the pelvis and posterolateral spine and may be used either standalone or in combination with autograft as a bone graft extender. The device is resorbed and replaced with host bone during the healing process.

Synthetic Bone Putty is a resorbable bone void filler comprised of biphasic ceramic granules suspended in an alkylene oxide polymer carrier. The device can be used either standalone or in combination with autograft bone as a bone graft extender. Synthetic Bone Putty is supplied terminally sterile in an open-barrel syringe applicator that is packaged in a sterile barrier blister pack. The device is offered in sizes of Small, Medium, and Large.