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The MacroPore Puricel Lipoplasty System is intended for use in the following surgical specialties when the fragmentation, emulsification, and aspiration of soft tissue is desired: - Neurosurgery - -Gastrointestinal and Affiliated Organ Surgery -Urological Surgery -Plastic and Reconstructive Surgery -General Surgery -Orthopedic Surgery - -Gynecological Surgery - -Thoracic Surgery -Laparoscopic Surgery The MacroPore Puricel Lipoplasty System is indicated for use when the fragmentation, emulsification, and aspiration of subcutaneous fatty tissues for aesthetic body contouring is desired.

The MacroPore Puricel Lipoplasty System is a single use, pre-assembled, manual lipoaspirate system that relies on house vacuum for its energy supply. The MacroPore Puricel Lipoplasty System consists of a cannula, connection tubing, and a waste collection container. The cannula handle is attached to the collection canister via connection tubing. The cannula is a hollow tube with a single opening near the tip to communicate house-vacuum to the tissues and subsequently fragment. emulsify, and aspirate subcutaneous fatty tissues from the patient into the waste collection canister for purposes of aesthetic body contouring. The collection canister contains various capped / sealed ports and a filter to trap large tissue masses The Puricel Lipoplasty cannula is provided in various sizes ranging from 15cm - 36cm in length and 3.0 ~ 4.6mm in diameter with a single opening near the tip of the cannula. The tip region of the cannula may have a single or multiple openings that range in size from 4mm to length distributed uniformly or randomly throughout the end of the cannula. The handle of the device is 20mm in diameter and may be provided in diameters ranging from 20mm in diameter. The connecting tubing is provided with an inner diameter of 9.6mm (3/8"), an outer diameter of 14.3mm (9/16"), and a wall thickness of 2.2mm. The tubing that connects the cannula handle to the waste canister is provided in a length of 4 feet and may be provided in lengths ranging from 1 - 8 feet. The bottom of the waste collection container is also provided with the same 3/8" inner diameter connection tubing of various lengths. The proximal end of the exiting connection tubing may be provided with a barbed tubing connector to assist in the attachment of like-sized tubing for purposes of connecting the MacroPore Puricel Lipoplasty System to house vacuum and / or assorted waste traps. Connection tubing leading to and from the waste collection container is provided with a stepped clamp to allow the operator to seal the connection tubing on both sides of the waste container and prevent spillage of the collected fluids / tissues.

The MacroPore Hydrosorb Spine System, in conjunction with traditional rigid fixation, is intended for use in spinal fusion procedures as a means to maintain the relative position of weak bony tissue such as allografts or autografts. The device is not intended for load bearing indications.

The MacroPore Hydrosorb Spine System is a resorbable graft containment system composed of various sized porous plates / sheet, non-porous plates / sheets, and associated fixation screws manufactured from polylactic acid (PLA). The MacroPore Hydrosorb Spine System is composed of MacroPore Sheets, Plates, and Screws provided with and without USP barium sulfate beads (18mg - 20mg/bead) imbedded into the PLA polymer for radiopacity. MacroPore Sheets and Plates can be cut with scissors to the desired shape and size. The MacroPore Power Pen can also be used to cut or shape the MacroPore Plates / Sheets to the desired shape or size. The MacroPore Sheet and Plates are fully malleable when heated to approximately 55°C (for example, by the use of sterile hot water), and thus can be conformed three dimensionally to most any anatomical orientation. Screws range in size from 2.4mm to 6.5mm in outer diameter with lengths ranging from 4mm to 30mm. The MacroPore Sheets and Plates are provided in various sizes ranging from 1.0mm to 5.0mm in thickness according to the region to be treated. The MacroPore Sheets and Plates range in size from as small as 24mm x 18mm to as large as 100mm x 100mm. The MacroPore Sheets and Plates are provided with and without macroporous holes. The macroporous holes range in size from 500 microns to 3,000 microns in diameter. The radiopaque barium sulfate beads have an approximate nominal mass of 18mg - 20mg and range in size from 0.5mm - 2.0mm in diameter. All configurations are to be within a mass of 100 grams of polymer. Various manual instruments (screw drivers, taps, drill bit, etc.) are used in conjunction with the MacroPore Hydrosorb Spine System to assist in the installation process.

The MacroPore Surgi-Wrap MAST Bioresorbable Sheet is to be used wherever temporary wound support is required, to reinforce soft tissues where weakness exists, or for the repair of hernia or other fascial defects that require the addition of a reinforcing or bridging material to obtain the desired surgical result. The resorbable protective film minimizes tissue attachment to the device in case of direct contact with the viscera.

MacroPore Surgi-Wrap MAST Bioresorbable Sheet is a resorbable implant in sheet form manufactured from poly lactic acid (PLA). MacroPore Surgi-Wrap MAST Bioresorbable Sheet can be cut with scissors to the desired shape and size. The MacroPore Power Pen can also be used to cut or shape the MacroPore Surgi-Wrap MAST Bioresorbable Sheet to the desired shape or size. MacroPore Surgi-Wrap MAST Bioresorbable Sheet is fully malleable when heated to approximately 55°C (for example, by the use of sterile hot water), and thus can be conformed three dimensionally to most any anatomical orientation. The MacroPore Surgi-Wrap MAST Bioresorbable Sheet can be used either alone or in conjunction with soft tissue fixation devices such as resorbable sutures. which can also serve to fixate the MacroPore Surgi-Wrap MAST Bioresorbable Sheet and prevent dislocation. The MacroPore Surgi-Wrap MAST Bioresorbable Sheet may be used in conjunction with various MacroPore manual instruments. MacroPore Surgi-Wrap MAST Bioresorbable Sheet is provided in various shapes such as rectangles, ovals, and circles and will be provided in other shapes and sizes as needed for particular surgical procedures. MacroPore Surgi-Wrap MAST Bioresorbable Sheet is provided in sheets of 25mm x 25mm to 500mm and will be provided in other shapes and sizes as needed for particular surgical procedures. The thickness of the MacroPore Surgi-Wrap MAST Bioresorbable Sheet ranges from 0.02 mm to 1.0 mm according to the region to be treated. The MacroPore Surgi-Wrap MAST Bioresorbable Sheet is provided in solid sheets. The borders of the sheets may be aligned with holes to attach suture material.

The MacroPore Cardio-Wrap (TS) is indicated for use as a pericardium replacement device in patients that may require re-operation within six months.

MacroPore Cardio-Wrap (TS) is a resorbable implant in sheet form manufactured from poly lactic acid (PLA). MacroPore Cardio-Wrap (TS) can be cut with scissors to the desired shape and size. The MacroPore Power Pen can also be used to cut or shape the MacroPore Cardio-Wrap (TS) to the desired shape or size. MacroPore Cardio-Wrap (TS) Sheet is fully malleable when heated to approximately 55℃ (for example, by the use of sterile hot water), and thus can be conformed three dimensionally to most any anatomical orientation. The MacroPore Cardio-Wrap (TS) can be used either alone or in conjunction with soft tissue fixation devices such as resorbable sutures, which can also serve to fixate the MacroPore Cardio-Wrap (TS) and prevent dislocation. The MacroPore Cardio-Wrap (TS) may be used in conjunction with various MacroPore manual instruments. MacroPore Cardio-Wrap (TS) is provided in various shapes such as rectangles, ovals, and circles and will be provided in other shapes and sizes as needed for particular surgical procedures. MacroPore Cardio-Wrap (TS) is provided in sheets of 10mm to 500mm x 500mm and will be provided in other shapes and sizes as needed for particular surgical procedures. The thickness of the MacroPore Cardio-Wrap (TS) ranges from 0.05 mm to 1.0 mm according to the region to be treated. The MacroPore Cardio-Wrap (TS) is provided in solid sheets. The borders of the sheets may be aligned with holes to attach suture material.

The MacroPore OS Reconstruction System is intended to maintain the relative position of weak bony tissue such as bone grafts, bone graft substitutes, or bone fragments from comminuted fractures. The flat Protective Sheets with pore sizes up to 2.5mm are also indicated for cement restriction in total joint arthroplasty procedures. Only when used in conjunction with traditional rigid fixation, the MacroPore OS Reconstruction System is intended to maintain the relative position of weak bony tissue in trauma and reconstructive orthopedic procedures involving: - Long bones - Flat bones - Short bones - · Irregular bones - · Appendicular skeleton - Thorax When used alone (without traditional rigid fixation), the MacroPore OS Reconstruction System is intended to maintain the relative position of bone grafts or bone graft substitutes in reconstructive orthopedic procedures involving: - · Tumor resections where bone strength has not been compromised - Iliac crest harvests - Ribs (excluding multiple segmental defects such as those found in flail chest) This device is not intended for use in the spine. The device is not intended for load bearing indications unless used in conjunction with traditional rigid fixation.

MacroPore OS Reconstruction System is a resorbable graft containment system composed of various sized porous sheet and sleeves, non-porous sheets and associated fixation screws and tacks manufactured from polylactic acid (PLA). The MacroPore OS Reconstruction System is composed of MacroPore OS Reconstruction System Protective Sheets, MacroPore OS Reconstruction System Protective Sleeves, and MacroPore OS Reconstruction Screws and Tacks. The MacroPore OS Reconstruction System Protective Sheets and Protective Sleeves can be cut with scissors to the desired shape and size. The MacroPore Power Pen can also be used to cut or shape the MacroPore OS Reconstruction System to the desired shape or size. MacroPore OS Reconstruction System Protective Sheets and Protective Sleeves are fully malleable when heated to approximately 55℃ (for example, by the use of sterile hot water), and thus can be conformed three dimensionally to most any anatomical orientation. The MacroPore OS Reconstruction System Protective Sheets can be rolled into a tube or used as a flat sheet. The MacroPore OS Reconstruction System Protective Sheets and Protective Sleeves can be used either alone or in conjunction with internal bone fixation devices such as plates and screws, which also can serve to fixate the MacroPore OS Reconstruction System and prevent dislocation. The MacroPore OS Reconstruction System Tacks range in size from 1.7mm to 2.2mm in diameter with lengths from 3.6mm to 5.6mm and the MacroPore OS Reconstruction System Screws range in size from 2.0mm to 4.75mm in diameter with lengths from 3.35mm to 30mm. The MacroPore OS Reconstruction System Protective Sheet is provided in sheets of 25 x 25 mm to 160 x 200 mm. The MacroPore OS Reconstruction System Protective Sleeves are provided in lengths of 150mm to 5mm with inner diameters that range from 5mm up to 40mm. The MacroPore Reconstruction System Protective Sleeves are provided in circular, square, trapezoidal, and parabolic shapes. The MacroPore OS Reconstruction System Protective Sleeves are provided with and without serrated edges and / or tapered end(s) for ease of surgical installation. The MacroPore OS Reconstruction System Protective Sheets and Protective Sleeves are provided with and without macroporous holes. The pore size ranges from 1.7mm to 4.0mm in diameter, with pores distributed randomly or uniformly throughout the sheet/sleeve in an offset or aligned pattern. The thickness of the MacroPore OS Reconstruction System Protective Sheets ranges from 0.5mm to 5.0mm according to the orthopedic region to be treated. The thickness of the MacroPore OS Reconstruction System Protective Sleeves ranges from 0.8mm to 5.0mm according to the orthopedic region to be treated.

The MacroPore Barrier Film is indicated for use as an orbital implant wrap to cover orbital implants used in enucleation surgery and to protect the surrounding orbital tissue from the surface of the implant.

MacroPore Surgical Barrier Film is a resorbable implant in sheet form manufactured from polylactides (PLA). MacroPore Surgical Barrier Film can be cut with scissors to the desired shape and size. MacroPore Surgical Barrier Film is fully malleable when heated to approximately 55°C (for example, by the use of sterile hot water), and thus can be conformed three dimensionally to most any anatomical orientation. The MacroPore Surgical Barrier Film is provided in various shapes such as squares, rectangles, ovals, and circles. The MacroPore Surgical Barrier Film will be provided in sheets of 30mm x 30mm to 200mm x 200mm so that the surgeon may cut specific shapes and sizes. The thickness of the MacroPore Surgical Barrier Film will range from 0.05 mm to 1.0 mm. The MacroPore Surgical Barrier Film will be provided in solid sheets and in porous sheets that have pores that range in pore size from 0.5mm to 3.0mm with pores distributed randomly or uniformly throughout the film in an offset or aligned pattern. The pores are spaced at a distance of 1.5mm or greater. The MacroPore Surgical Barrier Film is fabricated from polylactide (PLA).

The MacroPore OS Trauma System is intended to maintain the relative position of weak bony tissue such as bone graft substitutes, or bone fragments from comminuted fractures. The MacroPore OS Trauma System is also indicated for cement restriction in total joint arthroplasty procedures. Only when used in conjunction with traditional rigid fixation, the MacroPore OS Trauma System is intended to maintain the relative position weak bony tissue in trauma and reconstructive orthopedic procedures involving: - Long bones - Flat bones - Short bones - Irregular bones - Appendicular skeleton - Thorax When used alone (without traditional rigid fixation), the MacroPore OS Trauma System is intended to maintain the relative position of bone graft substitutes in reconstructive orthopedic procedures involving: - Tumor resections where bone strength has not been compromised - Iliac crest harvests - Ribs This device is not intended for use in the spine. The device is not intended for load bearing indications unless used in conjunction with traditional rigid fixation.

MacroPore OS Trauma System is a resorbable graft containment system composed of various sized porous sheet and sleeves, non-porous sheets and associated fixation screws manufactured from poly (L-lactide) 70:30 (PLA). The MacroPore OS Trauma System is composed of MacroPore OS Trauma Protective Sheets, MacroPore OS Trauma Protective Sleeves, and MacroPore OS Trauma Screws. The MacroPore OS Trauma Protective Sheets and Protective Sleeves can be cut with scissors to the desired shape and size. The MacroPore Power Pen can also be used to cut or shape the MacroPore OS Trauma to the desired shape or size. MacroPore OS Trauma Protective Sheets and Protective Sleeves are fully malleable when heated to approximately 55℃ (for example, by the use of sterile hot water), and thus can be conformed three dimensionally to most any anatomical orientation. The MacroPore Power Pen can also be used to cut or shape the MacroPore OS Trauma Protective Sheets and Protective Sleeves to the desired shape or size. The MacroPore OS Trauma Protective Sheets can be rolled into a tube or used as a flat sheet. The MacroPore OS Trauma Protective Sheets and Protective Sleeves can be used either alone or in conjunction with internal bone fixation devices such as plates and screws, which also can serve to fixate the MacroPore OS Trauma and prevent dislocation. The MacroPore OS Trauma Screws range in size from 2.0mm to 4.8mm in diameter. The MacroPore OS Trauma Protective Sheet is provided in sheets of 20 x 20 mm to 120 x 120 mm and will be provided in other sizes as needed for particular surgical procedures. The MacroPore OS Trauma Protective Sleeves are provided in lengths of 150mm to 5mm with diameters that range from 10mm up to 25mm. The MacroPore OS Trauma Protective Sheets and Protective Sleeves are provided with and without macroporous holes. The pore size ranges from 500 microns to 3000 microns in diameter, with pores distributed randomly or uniformly throughout the sheet/sleeve in an offset or aligned pattern. The thickness of the MacroPore OS Trauma Protective Sheets and Protective Sleeves ranges from 0.75 mm to 3.0 mm according to the orthopedic region to be treated.

The MacroPore Surgi-Wrap (TS) is to be used wherever temporary wound support is required, to reinforce soft tissues where weakness exists, or for the repair of hernia or other fascial defects that require the addition of a reinforcing or bridging material to obtain the desired surgical result. This includes, but is not limited to the following procedures: vaginal prolapse repair, colon and rectal prolapse repair, reconstruction of the pelvic floor and sacral colposuspension.

MacroPore Surgi-Wrap (TS) is a resorbable implant in sheet form manufactured from polylactic acid (PLA). MacroPore Surgi-Wrap (TS) can be cut with scissors to the desired shape and size. The MacroPore Power Pen can also be used to cut or weld the MacroPore Surgi-Wrap (TS) to the desired shape or size. MacroPore Surgi-Wrap (TS) is fully malleable when heated to approximately 55°C (for example, by the use of warm water), and thus can be conformed to anatomic structures. MacroPore Surgi-Wrap (TS) can be rolled into a tube or used as a flat sheet. It can be fixated with tissue fixation devices such as resorbable sutures, which also can serve to fixate the MacroPore tissue fixation devices such as resorbable sutures. MacroPore Surgi-Wrap (TS) may be used in conjunction with various MacroPore manual instruments. MacroPore Surgi-Wrap (TS) is provided in sheets of 10mm to 120mm x 120mm and will be provided in other shapes and sizes in accordance to the region to be treated. The thickness of the MacroPore Surgi-Wrap (TS) is provided with and without macroporous holes from 0.02 mm to 2.0 mm according to the region to be treated. The macroporous holes range in size from 50 microns to 3,000 microns in diameter and the sheets may be aligned with holes to attach suture material.

The MacroPore ENT Reconstruction Film is indicated for the following surgical applications: - 1). Tympanic membrane repair. - 2). Tympanoplasty in the middle ear. - 3). Nasal splinting and surgical repair of nasal septum. - 4). Guided tissue regeneration of the external ear. - 5). Prevents adhesions between the septum and the nasal cavity.

MacroPore ENT Reconstruction Film is a resorbable implant in sheet form manufactured from poly lactic acid (PLA). MacroPore ENT Reconstruction Film can be cut with scissors to the desired shape and size. The MacroPore Power Pen can also be used to cut or shape the MacroPore ENT Reconstruction Film to the desired shape or size. MacroPore ENT Reconstruction Film Sheet is fully malleable when heated to approximately 55°C (for example, by the use of sterile hot water), and thus can be conformed three dimensionally to most any anatomical orientation. The MacroPore ENT Reconstruction Film can be rolled into a tube or used as a flat sheet. It can be used either alone or in conjunction with soft tissue fixation devices such as resorbable sutures, which also can serve to fixate the MacroPore ENT Reconstruction Film and prevent dislocation. The MacroPore ENT Reconstruction Film may be used in conjunction with various MacroPore manual instruments. MacroPore ENT Reconstruction Film is provided in various shapes such as rectangles, ovals, and circles and will be provided in other shapes and sizes as needed for particular surgical procedures. MacroPore ENT Reconstruction Film is provided in sheets of 10mm x 10mm to 120mm x 120mm and will be provided in other shapes and sizes as needed for particular surgical procedures. The thickness of the MacroPore ENT Reconstruction Film ranges from 0.02 mm to 2.0 mm according to the region to be treated. The MacroPore ENT Reconstruction Film is provided with and without macroporous holes. The macroporous holes range in size from 50 microns to 3,000 microns in diameter and may be in aligned, offset, or random patterns. The borders of the sheets may be aligned with holes to attach suture material

A. General Indications: Trauma procedures of the midface or craniofacial skeleton. Specific Indications: 1). Comminuted fractures of the naso-ethmoidal infraorbital areas. 2). Comminuted fractures of the frontal sinus wall. 3). Pediatric midface or craniofacial trauma 4). Lefort (I, II, III) fractures. 5). Orbital floor fractures. 6). Fractures of the maxilla, zygoma, zygomatic arch, orbital rim, nasal, ethmoid, and lacrimal bones. 7). Trauma of the craniofacial skeleton including: frontal, parietal, temporal , sphenoid, and occipital bones. B. General Indications: Reconstructive procedures of the midface or craniofacial skeleton.. Specific Indications: 1). Infant craniofacial surgery (i.e., craniosynostosis, congentital malformations, trauma, etc.). 2). Lefort (I, II, III) osteotomies. 3). Tumor reconstruction in midface or craniofacial procedures. 4). Bone graft procedures in the midface or craniofacial skeleton. 5). Pediatric reconstructive procedures. 6). Reconstructive procedures of the craniofacial skeleton including: frontal, parietal, temporal, sphenoid, and occipital bones. 7). Craniotomy flap fixation.

MacroPore FX, PS, NS, LP is a resorbable bone fixation system composed of various sized porous sheets, non-porous sheets, and associated fixation tacks and screws manufactured from poly lactic acid. The MacroPore FX, PS, NS, LP are composed of MacroPore FX, PS, NS, LP Protective Sheets and MacroPore FX and LP Screws and Tacks. MacroPore Protective Sheets can be cut with scissors to the desired shape and size. The MacroPore Power Pen can also be used to cut or shape the MacroPore Plates and Protective Sheets to the desired shape or size. The MacroPore Plate and Protective Sheets are fully malleable when heated to approximately 55°C (for example, by the use of sterile hot water), and thus can be conformed three dimensionally to most any anatomical orientation. The MacroPore FX, PS, NS, LP bone fixation system includes a selection of resorbable screws, tacks, and associated manual instruments. Tacks range in size from 1.5mm to 2.0mm in outer diameter. Screws range in size from 2.0mm in outer diameter. The MacroPore Plates and Protective Sheets come in various sizes ranging from 0.5mm in thickness according to the region to be treated. The MacroPore Protective Sheets range in size from as small as 20mm x 20mm to as large as 120mm x 120mm. The MacroPore Protective Sheet is provided with and without macroporous holes. The macroporous holes range in size from 500 microns to 3,000 microns in diameter. All configurations are to be within a mass of 18 grams of polymer. Various manual instruments (PowerTack Driver, StarBurst Screw drivers, Tack Pusher, taps, drill bit, etc.) are used in conjunction with the MacroPore FX, PS, NS, LP bone fixation system to assist in the installation process.