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PLEXUR M is intended for use in filling bony voids or gaps of the skeletal system (i.e. extremities and pelvis) that are not intrinsic to the stability of the bony structure. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. In addition, Plexur M may be used in conjunction with autograft as a bone void filler in the spine. PLEXUR M is resorbed/remodeled and is replaced by host bone during the healing process.

PLEXUR M is a bone void filler product that contains, as a key constituent, processed human bone particles that are mixed with resorbable/biodegradeable non-tissue components. It is intended to be heated at the time of use, whereupon it becomes moldable, thus allowing the surgeon to pack it into the implant site or shape it to accommodate variations in the geometry and size of the particular implant site. As it cools down, the PLEXUR M returns to its normal hardened/rigid state and remains this way at body temperature. The surgeon may further shape, cut or grind PLEXUR M in the hardened state using conventional surgical instruments. PLEXUR M is packaged/provided for single use in a sterile form. PLEXUR M is resorbed/remodeled and is replaced by host bone during the healing process. A compact, single use heater is available as a means to heat the PLEXUR M at the time of use to make it pliable. Alternatively, PLEXUR M may be heated in a water bath.

PLEXUR P is intended for use in filling bony voids or gaps of the skeletal system (i.e., spine, pelvis and extremities) that are not intrinsic to the stability of the bony structure. These defects may be surgically created osseous defects or osseous defects resulting from traumatic injury to the bone. Plexur P may also be used as a bone graft extender in the spine. PLEXUR P is resorbed/remodeled and is replaced by host bone during the healing process.

PLEXUR P is bone void filler that contains as its principal constituents processed human allograft bone tissue and a resorbable polymer. PLEXUR P is produced in various physical forms/shapes/geometries and may be further shaped or cut by the surgeon to meet the particular needs and preferences of the surgeon. PLEXUR P is intended for use as bone void filler in bony voids or gaps of the skeletal system (i.e., spine, pelvis, and extremities) not intrinsic to the stability of the bony structure. Plexur P mav also be used as a bone graft extender in the spine. PLEXUR P is provided in ready-to-use form in various package sizes by volume or dimension and is intended for single patient use.

PLEXUR M is intended for use in filling bony voids or gaps of the skeletal system (i.e., extremities, pelvis) that are not intrinsic to the stability of the bony structure. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. PLEXUR M is resorbed/remodeled and is replaced by host bone during the healing process.

PLEXUR M is a bone void filler product that contains, as a key constituent, processed human bone particles that are mixed with resorbable/biodegradeable non-tissue components. It is intended to be heated at the time of use, whereupon it becomes moldable, thus allowing the surgeon to pack it into the implant site or shape it to accommodate variations in the geometry and size of the particular implant site. As it cools down, the PLEXUR M returns to its normal hardened/rigid state and remains this way at body temperature. The surgeon may further shape, cut or grind PLEXUR M in the hardened state using conventional surgical instruments. PLEXUR M is packaged/provided for single use in a sterile form. PLEXUR M is resorbed/remodeled and is replaced by host bone during the healing process. A compact, single use heater is available as a means to heat the PLEXUR M at the time of use to make it pliable. Osteotech is seeking approval of this single use heater as part of this 510(k) submission. Alternatively, PLEXUR M may be heated in a water bath.

PLEXUR P is intended for use in filling bony voids or gaps of the skeletal system (i.e., extremities, pelvis) that are not intrinsic to the stability of the bony structure. These defects may be surgically created osseous defects or osseous defects resulting from traumatic injury to the bone. PLEXUR P is resorbed/remodeled and is replaced by host bone during the healing process.

PLEXUR P is a bone void filler that contains as its principal constituents processed human allograft bone tissue and a resorbable polymer. PLEXUR P is produced in various physical forms/shapes/geometries and may be further shaped or cut by the surgeon to meet the particular needs and preferences of the surgeon. PLEXUR P is intended for use as a bone void filler in bony voids or gaps of the skeletal system (i.e., extremities, pelvis) not intrinsic to the stability of the bony structure. PLEXUR P is provided in ready-to-use form in various package sizes by volume or dimension and is intended for single patient use.

GRAFTON® DBM is intended to be packed into bony voids or gaps to fill and/or augment dental intraosseous, oral and cranio-/maxillofacial defects. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone, including periodontal/infrabony defects; alveolar ridge augmentation (sinusotomy, osteotomy, cystectomy); dental extraction sites (ridge maintenance, implant preparation/placement); sinus lifts; cystic defects; craniofacial augmentation. GRAFTON® DBM may be used alone in a manner comparable to autogenous bone chips or allograft bone particulate (demineralized freeze dried bone), or it may be mixed with either allograft or autograft bone or bone marrow as a bone graft extender. GRAFTON® DBM is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. GRAFTON® DBM is resorbed/remodeled and is replaced by host bone during the healing process.

GRAFTON® DBM is a human bone allograft product containing human demineralized bone matrix (DBM) and an inert additive for intraoperative handling. It is intended to fill and/or augment dental intraosseous, oral and cranio-/maxillofacial defects. GRAFTON® DBM is provided ready-to-use in various physical forms. It is packaged in various sizes by volume or dimension for single patient use. GRAFTON® DBM is a demineralized bone product that is osteoconductive as well as osteoinductive in an athymic rat assay. It is prepared via a proprietary processing method of Osteotech, Inc. that has been validated to consistently produce DBM that is osteoinductive in an athymic rat assay.

GRAFTON® DBM is intended for use as a bone graft extender, bone graft substitute, and bone void filler in bony voids or gaps of the skeletal system (i.e., spine, pelvis and extremities); surgically created defects or defects created by trauma. The voids or gaps may be large or small and may be unicortical or bicortical. GRAFTON® DBM is resorbed/remodeled and is replaced by host bone during the healing process.

GRAFTON®DBM is a human bone allograft product containing human demineralized bone matrix (DBM) and an inert additive for intraoperative use in filling bony voids or gaps of the skeletal system needing structural support. It is intended to be used in bony voids or gaps that are not intrinsic to the stability of the bony structure. GRAFTON® DBM is provided ready-to-use in various physical forms and in various package sizes by volume or dimension. GRAFTON® DBM is a demineralized bone product that is osteoconductive as well as osteoinductive in an athymic rat assay. It is prepared via a proprietary process of Osteotech, Inc. that has been validated to consistently produce DBM that is osteoinductive in an athymic rat assay. Product and process consistency are confirmed via ongoing testing of GRAFTON® DBM product for osteoinductivity in this validated athymic rat assay utilizing a five point linear scale to score bone formation at 28 days.

The GraftCage™ TLX is a vertebral body replacement device intended to replace a collapsed, damaged, or unstable vertebral body in the thoracic or lumbar spine (T1-L5). The GraftCage TLX is indicated for a partial or total vertebrectomy for cases of tumor or trauma (i.e., fracture). The GraftCage TLX is intended to achieve anterior decompression of the spinal cord and neural tissues and to restore the height of a collapsed vertebral body. The GraftCage TLX is intended for use with supplemental internal spinal fixation systems that are cleared by FDA for use in the thoracic and lumbar spine. These systems include posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems. The use of bone grafting material with the GraftCage TLX is optional.

The GraftCage TLX is a device designed to replace a thoracic or lumbar vertebral body and to support axial compression loads following vertebrectomy for the treatment of spinal tumors and in cases of spinal trauma/fracture. The GraftCage TLX is made from implantable PEEK (polyetheretherketone) polymer. The GraftCage TLX is rectangular -to- oval in shape, with its anterior aspect slightly convex and posterior aspect slight concave. One central (axial) fenestration and two fenestrations on each anterior and posterior aspect provide locations for the addition of bone grafting material. The superior and inferior aspects have ridges that resist expulsion and /or migration after implantation. The device is nonlordotic (0°) i.e., parallel. The lateral aspects are tapered, or bulleted, for ease of insertion. Two threaded holes, one at each lateral aspect, interface with the insertion tool. The insertion tool is a shaft attached to a handle. The shaft has a threaded end that matches both threaded holes on the GraftCage TLX and allows the surgeon to hold the GraftCage TLX while implanting it into the patient. Each threaded hole is at a different angle relative to the long axis of the implant. The different angles allow the surgeon to choose the best surgical approach depending upon the specific clinical situation.

VIAGRAF® DBM Paste is intended for use in filling bony voids or gaps of the extremities that are not intrinsic to the stability of the bony structure. The voids or gaps may be surgically created defects or defects created by traumatic injury to the bone. VIAGRAF® DBM Paste is resorbed/remodeled and is replaced by host bone during the healing process.

VIAGRAF DBM Paste is an osteoconductive human bone allograft product consisting of human demineralized bone matrix (DBM) to which an inert starchbased carrier has been added. It is intended for use in filling bony voids or gaps of the extremities not intrinsic to the stability of the bony structure. VIAGRAF® DBM Paste is provided in a ready-to-use paste-like, malleable form that can be molded or manipulated by the user into various shapes. It is provided in various package sizes by volume.

The GraftCage™ ACX is a vertebral body replacement device intended to replace a collapsed, damaged, or unstable vertebral body in the thoracic or lumbar spine (TI-L5). The GraftCage™ ACX is indicated for a partial or total vertebrectomy for cases of tumor or trauma (i.e., fracture). The GraftCage™ ACX is intended to achieve anterior decompression of the spinal cord and neural tissues and to restore the height of a collapsed vertebral body. The GraftCage™ ACX is intended for use with supplemental internal spinal fixation systems that are cleared by FDA for use in the thoracic and lumbar spine. These systems include posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems. The use of bone grafting material with the GraftCage™ ACX is optional.

The GraftCage™ ACX is a device designed to replace a thoracic or lumbar vertebral body and to support axial compression loads following vertebrectomy for the treatment of spinal tumors and in bases of spinal trauma/fracture. The GraftCage™ ACX is made from implantable PEEK-OPTIMA (polyetheretherketone) polymer. The GraftCage™ ACX is basically rectangular in shape. One central (axial) fenestration and one fenestration on each lateral aspect (on certain sizes) provide locations for the addition of bone grafting material. The superior and inferior aspects have ridges that resist expulsion and for migration after implantation. The device offers lordotic and non-lordotic i.e., parallel configurations. The posterior aspect of both design configurations is tapered, or bulleted, for ease of insertion. A single threaded hole at the posterior aspect interfaces with the insertion tool. The insertion tool is a shaft attached to a handle. The shaft has a threaded end that matches the threaded hole on the GraftCage™ ACX and allows the surgeon to hold the GraftCage™ ACX while implanting it into the patient.

GRAFTON PLUS®DBM Paste is intended to be packed into bony voids or gaps to fill and/or augment dental intraosseous, oral and cranio-/maxillofacial defects. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone, including periodontal/infrabony defects; alveolar ridge augmentation (sinusotomy, osteotomy, cystectomy); dental extraction sites (ridge maintenance, implant preparation/placement); sinus lifts; cystic defects; craniofacial augmentation. GRAFTON PLUS® DBM Paste may be used alone in a manner comparable to autogenous bone chips or allograft bone particulate (demineralized freeze dried bone), or it may be mixed with either allograft or autograft bone or bone marrow as a bone graft extender. GRAFTON PLUS® DBM Paste is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. GRAFTON PLUS® DBM Paste is absorbed/remodelled and replaced by host bone during the healing process.

GRAFTON PLUS® DBM Paste is a human bone allograft product consisting of human demineralized bone matrix (DBM) mixed with an inert starch-based additive. It is intended to fill and/or augment dental intraosseous, oral and cranio-/maxillofacial defects. GRAFTON PLUS® DBM Paste is provided in a ready-to-use paste-like, malleable form that can be molded or manipulated by the user into various shapes. It is provided in various package sizes by volume. GRAFTON PLUS® DBM Paste is an osteoinductive bone graft product in that it forms ossicles of bone when implanted ectopically in an athymic rat model. It is produced using a process that has been validated to consistently produce osteoinductive DBM as measured in the athymic rat test model.