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The UltraConcentrator™ Permeability Hemodialyzer is indicated for use as an ultrafiltrator for the selective removal of undesirable plasma water and small dissolved solutes from blood plasma proteins and formed cellular elements, as may be present in cases of acute hemodilution such as following cardiopulmonary bypass.

The UltraConcentrator Permeability Hemodialyzer is a device that is used to remove plasma water from dilute blood plamsa proteins, increasing the concentration of plasma proteins and formed cellular elements. The UltraConcentrator is constructed of semi-permeable hollow fibers which divide the device into two compartments. An inner pathway for diluted blood perfusate is defined by the inlet and outlet connectors and flow dispersion headers which are connected through the inner lumen of semi-permeable, hollow fiber membranes. Surrounding the hollow fibers is an enclosed, vented compartment for the collection of ultrafiltrate waste water. When perfusate fluid passes through the inner diameter of the hollow fibers, water and small dissolved solutes can pass through the semi-permeable membrane walls into the annular ultrafiltrate compartment to then be discarded. The UltraConcentrator may be used manually or it may be used with the UltraConcentrator Processor, a pneumatically driven device that provides automatic processing of the UltraConcentrator. The UltraConcentrator Permeability Hemodialyzer is not intended for use with direct patient connection, nor is it intended for use as a dialyzer. Although constructed of highly permeable membrane material, the low total membrane surface area of the UltraConcentrator inherently limits the maximum rate of water removal. Neither an ultrafiltration rate monitor nor a controller is necessary.

Pro Osteon® 500R Resorbable Bone Void Filler is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. Pro Osteon 500R is indicated to be gently packed into bony voids or gaps of the skeletal system (i.e., the extremities, spine 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.

Pro Osteon 500R Resorbable Bone Void Filler is an osteoconductive porous implant similar in structure to human cancellous bone. It is supplied sterile in various shapes and sizes. Pro Osteon 500R has a trabecular structure which resembles the multidirectional interconnected porosity of cancellous bone. It has a median pore diameter of 435 microns. The implant is trabecular calcium carbonate covered by a very thin outer layer of calcium phosphate representing approximately 13% of the total implant structure. The calcium phosphate is located on the outer surface of the porosity throughout the entire structure of the implant. It is approximately 2 to 10 microns in thickness and overlays the calcium carbonate substructure. Once implanted, the calcium phosphate outer laver will slowly resorb, delaving exposure of the underlying and faster resorbing calcium carbonate. Calcium carbonate resorption will normally occur within six months or less. When Pro Osteon 500R is placed in direct contact with viable bone, the reticulated spaces in the implant are infiltrated with tissue. Bone formation occurs in apposition to the Pro Osteon 500R surface and within the interstices of the implant skeleton. As the implant resorbs, bone and soft tissue grow into the space previously occupied by the implant.

The Interpore Inducer Bone Graft Delivery Syringe is indicated for the delivery of allograft, autograft or synthetic bone graft material to an orthopaedic surgical site. In addition, it is designed to facilitate pre-mixing of a bone graft material with I.V. fluids, blood, plasma, bone marrow or other specific blood component(s) as deemed necessary by the clinical use requirements. The Interpore Inducer has a volume of approximately 15 cc.

The INTERPORE Inducer Bone Graft Delivery Syringe is a piston syringe intended for use to deliver allograft, autograft or synthetic bone graft materials to an orthopaedic surgical site. In addition, it is designed to facilitate pre-mixing of bone graft materials with I.V. fluids, blood, plasma, bone marrow or other specific blood component(s) as deemed necessary by the clinical use requirements. The Interpore Inducer has a volume of approximately 15cc. The Interpore Inducer is a specially designed syringe specifically intended to deliver bone graft materials to a surgical site. It is supplied sterile in double aseptic transfer packaging. The Interpore Inducer consists of a syringe barrel, syringe top cap, piston and plunger. The distal end of the syringe has a removable top cap which must be aseptically removed in order to load the bone graft material into the syringe. After loading the syringe, the top cap may be reattached to the syringe to constrain the contents of the syringe or to minimize potential contamination of the syringe contents. In addition, the top cap has a male luer-lok connector which may be attached to any standard female luer adapter for fluid transfer. The piston of the syringe is designed to eject fluids or blood components and bone graft materials into the operative site. It is also designed to be the attachment point for the syringe plunger. The proximal end of the piston also has a female luer-lok connector which may be connected to any standard male luer adapter for delivery of fluids or blood components into the syringe. The syringe plunger is provided separately and is attached to the proximal end of the syringe piston immediately prior to bone graft expulsion from the syringe into the surgical site.

The Odontit Autogenous Bone Collection Device is indicated for use as an aspirator for the removal and collection of blood, autogenous bone chips, or other extraneous fluids from a surgical site. Using a vacuum source, the Odontit aspirator will remove materials (including blood, bone chips and other fluids) from the surgical site and pass them through a stainless steel screen which is designed to capture and collect autogenous bone. At the option of the surgeon, this bone may be removed from the aspirator, washed and cleansed as necessary, and returned to the same patient as an autogenous bone graft. The capacity for bone collection in the screen is approximately 16 cc.

The Odontit Autogenous Bone Collection Device is a portable suction device intended for use as an aspirator for the removal and collection of blood, autogenous bone, or other extraneous fluids from a surgical site. The device consists of the following components: Body Assembly, Aspirator Tip, Screen Filter, Flex tubing, Rigid tubing and a Plunger.

The Membrane Tack is a titanium alloy, machined, miniature nail designed to stabilize guided tissue regeneration membranes during the healing process by providing an attachment mechanism for the membrane to resident and adjacent bone at the surgical site. The guided tissue regeneration membranes are intended for use in wrapping bone or cartilage, or in soft tissue defects when bony or soft tissue ingrowth and attachment is required Guided tissue regeneration membranes are also appropriate for augmentation of slight tissue deficiencies. These are medical devices currently cleared by FDA and commercially available for sale in the United States. While not yet classified by FDA, the FDA Dental Advisory Panel has recommended a Class II Classification for guided tissue regeneration devices, both resorbable and non-resorbable.

The IMZ Membrane Tack System consists of components and instruments designed to stabilize guided tissue regeneration membranes during the healing process by providing an attachment mechanism for the membrane to resident and adjacent bone at the surgical site. The Membrane Tack is fabricated of titanium alloy and has a thin low profile head and a barb at the tip for stabilization.

The INTERPORE Self-Tapping Threaded Implant is indicated for oral reconstruction in the totally edentulous mandible or maxilla, in large edentulous spans, for bilateral and unilateral free-ends and in restoration of single tooth edentulous spaces. It is designed to become an osteointegrated prosthesis allowing the attachment of removable and fixed partial or complete prosthodontic appliances. The external hexagonal projection is intended to provide an attachment system which minimizes crown rotation in single tooth applications.

The INTERPORE Self-Tapping Threaded Implant is a commercially pure titanium, machined, endosseous threaded implant with an external hex configuration on the top of the implant. The outer surface of the implant is externally threaded. The external threads originate at the inferior edge of the machined coronal collar of the implant and continue to the apical end of the implant. The apical end of the implant contains flutes which act as cutting edges to aid installation of the implant during the self-tapping procedure. The inner diameter of the implant is internally threaded with 2.5 mm threads designed for acceptance of a placement screw, a hex cover screw, a healing abutment, and a retaining screw. The latter device affixes the prosthetic appliance to the implant. The incorporation of the external hexagonal projection is intended to provide an attachment system which minimizes crown rotation in single tooth applications. It is designed to mechanically interface with a female hexagonal configuration on the mating prosthesis such that, when the retaining screw is tightened into place, the crown will not be allowed to rotate.