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The Inion CompressOn™ products are intended for maintenance of alignment and fixation of bone fractures, comminuted fractures, osteotomies, arthrodeses or bone grafts or allografts) in the presence of appropriate additional immobilization (e.g., rigid fixation implants, cast or brace). In addition, the Inion CompressOn™ Ø 3.5/4.0/4.5/5.0/6.0 mm products are specifically intended for use in following indications: A. General indication: maintenance of reduction of cancellous bone fractures, osteotomies or arthrodeses of the upper extremity, ankle and foot in the presence of appropriate brace and/or immobilization. B. Specific indications: fractures and osteotomies of the malleoli, and ankle fractures.

Inion CompressOn™ Screws are cannulated headless compression screws made of degradable co-polymers composed of L-lactic acid and D-lactic acid. These polymers have a long history of safe medical use and they degrade in vivo by hydrolysis into alpha-hydroxy acids that are metabolised by the body. The implants retain sufficient strength to fulfil their intended function during the healing period of the fracture or osteotomy, and degrade gradually thereafter. Bioresorption takes place within two to four years. The implants are provided sterile to the user and are not to be re-used or re-sterilized. Inion CompressOn™ Screws have nominal dimensions ranging from 2.7-6.0 mm in diameter and 12-90 mm in length. They are designed to be inserted using Inion® instrumentation: drill bits, bone taps, drill taps, screwdriver shafts, drill sleeves, K-wires and depth gauges. The screws can be inserted over a guide wire. Inion CompressOn™ Screws provide fixation and are not intended to replace healthy bone or withstand the stress of full load bearing.

These INION BIORESTORE™ implants are bone graft substitutes indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. INION BIORESTORE™ 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.

Inion BioRestore™ is a biodegradable bone graft substitute made of bioactive, biodegradable glass. Inion BioRestore™ system consists of different size cylinders, blocks and morsels made of degradable bioactive glass. When implanted, a kinetic modification of the surface occurs, resulting in the formation of a calcium phosphate layer that is essentially similar in composition and structure to the hydroxyapatite found in bone mineral. This apatite layer provides scaffolding onto which the patient's new bone will grow allowing complete repair of the defect. Based on pre-clinical testing, most of the material degrades in vivo in six months. The material is radiopaque. Inion BioRestore™ implants are intended for single use and are provided sterile to the user. They are completely synthetic and non-pyrogenic. With this modification, additional packaging sizes and packaging configurations are introduced for the Inion BioRestore™ morsels.

The Inion spinal graft containment plate 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. This device is not intended for load bearing indications.

INION S-2™ Biodegradable Anterior Thoraco-Lumbar Fusion System plates are bioresorbable anterior thoraco-lumbar fusion devices for graft containment (screws and plates). The plates are made of degradable poly(L-lactide-co-D,L-lactide 80:20). Based on in vitro data: the implants retain most of their initial strength 16 weeks and gradually lose their strength thereafter. Bioresorption takes place within two to four years. The implants are provided sterile to the user and are non-collagenous. The shelf life of the device is 3 years. INION S-2™ Biodegradable Anterior Thoraco-Lumbar Fusion System devices provide fixation and are not intended to replace healthy tissues or withstand the stress of full load bearing. The purpose of this submission is a line extension for new sizes.

The INION FreedomPin™ products are indicated for maintenance of alignment and fixation of bone fractures, osteotomies, arthrodeses or bone grafts in the presence of appropriate additional immobilization (e.g. rigid fixation implants, cast, brace).

The Inion FreedomPin™ products are intended to maintain accurate alignment of fragments of fractured bone in the presence of appropriate immobilization. The INION FreedomPin™ products are made of degradable co-polymers composed of L-lactic acid and D-lactic acid. These polymers have a long history of safe medical use and they degrade in vivo by hydrolysis into alpha-hydroxy acids that are metabolised by the body. The pins are dyed green for better visualization during the surgical procedure by a minimal amount of Drug and Cosmetic (D&C) Green No. 6, which is used in several biodegradable sutures and implants. Inion FreedomPins have nominal dimensions ranging from 1.5 - 3.2 mm in diameter and 30 - 70 mm in length. In addition, sterile Pin Kits are offered which contain 2-3 pins and the required sterile, single use instruments needed for the insertion. The implants retain sufficient strength to fulfil their intended function during the healing period of the fracture or osteotomy, and degrade gradually thereafter. Bioresorption takes place within two to four years. The implants are provided sterile to the user and are not to be resterilized. Inion FreedomPins provide fixation and are not intended to replace healthy bone or withstand the stress of full load bearing. Inion FreedomPins are designed to be used with customized instrumentation consisting of drill bits. K-wires, applicators. and arthroscopic pistons and tips.

The Inion FreedomScrew™M products are intended for maintenance of alignment and fixation of bone fractures, comminuted fractures, osteotomies, arthrodeses or bone grafts (i.e., autografts or allografts) in the presence of appropriate additional immobilization (e.g., rigid fixation implants, cast or brace). In addition, the Inion FreedomScrew™ Ø3.5/4.0/4.5 mm products are specifically intended for use in following indications: A. General indications: maintenance of reduction and fixation of cancellous bone fractures, osteotomies or arthrodeses of the upper extremity, ankle and foot in the presence of appropriate brace and/or immobilization. B. Specific indications: fractures and osteotomies of the malleoli, and ankle fractures.

Inion FreedomScrew™ implants are internal fracture fixation devices made of degradable co-polymer composed of 100 % poly(L-lactide-co-D,L-lactide). Based on in vitro testing, the implants retain their initial strength up to 12 weeks after implantation, and gradually lose their strength thereafter. Bioresorption takes place within two to four years. Inion FreedomScrews™ are in the range of diameter: 2.0 - 4.5 mm and length: 10 - 90 mm. The designs include fully and partially threaded screws, as well as solid and cannulated screws. Inion FreedomScrew™ implants are used together with the previously cleared Inion OTPS™ plating systems, as well as alone according to their indications for use. The Inion FreedomScrew™ products provide fixation and are not intended to replace healthy bone or withstand the stress of full load bearing. Inion FreedomScrews™ are provided sterile to the user and are non-collagenous. The shelf life of the device is 3 years and they are intended for single use only. The Inion FreedomScrews™ are primarily designed to be used with customized Inion instrumentation, such as drill bits, bone taps, holding sleeves, screwdriver shafts, countersinks, depth gauges, K-wires and cutting instruments, as well as with ISO 5835/ISO 9714 compatible instrumentation.

Inion CPS Orbital Plates are intended for use in trauma and reconstructive procedures of the orbital cavity as part of the Inion CPS 1.5/2.0/2.5 Bioabsorbable Fixation System.

The Inion CPS® Orbital Plate fixation plates made of resorbable polylactic acid/trimethylcarbonate copolymer: This copolymer degrades in vivo by hydrolysis into L-lactic, D-lactic and TMC monomers which are then metabolised by the body. Inion CPS® Orbital Plates are of dimensions: length: 25-40 mm, width: 24-40 mm, thickness: 0.5 mm. The fixation of the plates with Inion CPS® ø1.5 mm screws. The implants retain sufficient strength to fulfil their intended function during the healing period of the fracture or osteotomy, and degrade gradually thereafter. Bioresorption takes place within two to four years. The implants are provided sterile to the user and are not to be resterilized. The Inion CPS® Orbital Plates provide fixation and are not intended to replace healthy bone or withstand the stress of full load bearing. The Inion CPS® Orbital Plates are designed to be used with customized instrumentation consisting of template, drill bits, bone taps, screw driver, plate benders and a heating device.

The Inion BioRestore™ implants are bone graft substitutes indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. Inion BioRestore™ 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.

Inion. BioRestore™ is an osteoconductive and osteostimulative bioactive bone graft device. In vivo tests have demonstrated more bone formation at each post-implantation timepoint and more total bone formation compared to other osteoconductive devices such as hydroxyapatite. In vitro cell culture tests with human adipose mesenchymal stem cells have demonstrated an osteostimulative effect, defined as the active stimulation of osteoblast proliferation and differentiation as evidenced by alkaline phosphatase activity. This stimulation has been attributed as being the result of the interaction between osteoblasts and the ionic dissolution products released from Inion BioRestore™ during its absorption. Clinical data on humans on rate and extent of bone formation observed in cell culture and animal models has not been established. Bioactive materials are those materials that elicit a specific biological response at the interface of the material that results in the formation of a bond between the tissues and the material. Osteostimulation is a "... property of some bioactive materials to enhance, actively stimulate both the proliferation and differentiation of progenitor cells (e.g. mesenchymal stem cells) ... "1 The Inion BioRestore™ system consists of different size cylinders, blocks and morsels made of degradable bioactive glass. When implanted, a kinetic modification of the surface occurs, resulting in the formation of a calcium phosphate layer that is essentially similar in composition and structure to the hydroxyapatite found in bone mineral. This apatite laver provides scaffolding onto which the patient's new bone will grow allowing complete repair of the defect. Based on pre-clinical testing, most of the material degrades in vivo in six months. The material is radiopaque. Inion BioRestore™ implants are intended for single use and are provided sterile to the user. They are completely synthetic and noncollagenous.

The INION BIORESTORE™ implants are bone graft substitutes indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. INION BIORESTORE™ 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.

Inion BioRestore™ is an osteoconductive and osteostimulative bioactive bone graft device. In vivo tests have demonstrated more bone formation at each post-implantation timepoint and more total bone formation compared to other osteoconductive devices such as hydroxyapatite. In vitro cell culture tests with human adipose mesenchymal stem cells have demonstrated an osteostimulative effect, defined as the active stimulation of osteoblast proliferation and differentiation as evidenced by alkaline phosphatase activity. This stimulation has been attributed as being the result of the interaction between osteoblasts and the ionic dissolution products released from Inion BioRestore™ during its absorption. Clinical data on humans on rate and extent of bone formation observed in cell culture and animal models has not been established. Bioactive materials are those materials that elicit a specific biological response at the interface of the material that results in the formation of a bond between the tissues and the material. Osteostimulation is a "... property of some bioactive materials to enhance, actively stimulate both the proliferation and differentiation of progenitor cells (e.g. mesenchymal stem cells) ... "1.2 Inion BioRestore™ system consists of different size cylinders, blocks and morsels made of degradable bioactive glass. When implanted, a kinetic modification of the surface occurs, resulting in the formation of a calcium phosphate layer that is essentially similar in composition and structure to the hydroxyapatite found in bone mineral. This apatite layer provides scaffolding onto which the patient's new bone will grow allowing complete repair of the defect. Based on pre-clinical testing, most of the material degrades in vivo in six months. The material is radiopaque. Inion BioRestore™ implants are intended for single use and are provided sterile to the user. They are completely synthetic and noncollagenous.

The Inion Hexalon™ Biodegradable ACL/PCL Screw is intended for soft tissue (including ligament, tendon, and bone-tendon-bone graft) fixation to bone in surgeries of the knee, shoulder, elbow, ankle, foot, hand and wrist where the offered screw sizes are patient appropriate.

Inion Hexalon™ Biodegradable ACL/PCL Screw is made of resorbable polylactic acid / trimethylenecarbonate copolymer. The Inion Hexalon™ Biodegradable Screws are coloured green for better visualization during surgical operation. Inion Hexalon™ Biodegradable ACL/PCL Screws gradually lose their strength during 18-36 weeks. Bioresorption takes place within two to four years. Inion Hexalon™ Biodegradable ACL/PCL Screw is sterile and non-collagenous. The shelf life of the product is three years.