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The Kyphon Discyphor Direct™ Catheter System for the Functional Anaesthetic Discography™ Procedure, and its components, are intended for use in delivering either a single dose or continuous administration of radiopaque contrast, local anaesthetics, and/or saline solution to the intradiscal space. The Kyphon Discyphor Direct™ Outer Needle is intended for use to access the area adjacent to the intradiscal space for the purpose of facilitating sequential placement of the Discyphor Direct™ Inner Needle and Discyphor Direct™ Catheter into the intradiscal space. The Discyphor Direct ""Outer Needle is intended to be used only with the Discyphor Direct™ Catheter System. The Kyphon Discyphor Direct™ Inner Needle is intended to access the nucleus of an intervertebral disc for the purpose of performing provocative discography and facilitating placement of the Discyphor Direct™ Catheter into the intradiscal space. The Discyphor Direct " Inner Needle can be used to deliver contrast, antibiotic, and/or saline into an intervertebral disc. The Discyphor Direct" voner Needle is intended to be used only with the Discyphor Direct " Catheter System.

The Discyphor Direct™ Catheter System is comprised of a Discyphor Direct™ Catheter, a Balloon Inflation Assembly, a Stopcock Assembly, an Injection Assembly, an EPI-Guard Catheter Anchoring Device, Adhesive Clips, a Sheet of Labels, 1-cc Syringes and a Discyphor Direct™ Outer Needle (with stylet) and a Discyphor Direct™ Inner Needle (with stylet). The Discyphor Direct™ Catheter is a micro-catheter with a double lumen shaft and an inflatable balloon at its distal end. The Balloon Inflation Assembly, a Stopcock Assembly, an Injection Assembly are intended to be connected to the lumens of the catheter and to provide access to the lumens. The Balloon Inflation Assembly consists of an a 3-cc Syringe and a pressure relief valve. The Stopcock Assembly consists of a Stopcock, a Touhy Borst adapter and a Wing Nut. The Injection Assembly consists of a Touhy Borst adapter, a One-way valve and a Wing Nut. The EPI-Guard Catheter Anchoring Devices secures the catheter close to the needle puncture site. The Adhesive Clips are used to secure the catheter to the patient. The 1-cc Syringes can be used for injection of contrast, antibiotic, and/or saline into the disc space. The labels provided on the Label Sheet are used to identify the solutions used during the procedure or to denote the level at which the Discyphor Catheter has been placed. The Discyphor Direct " Outer Needle is manufactured from stainless steel and has a stainless steel stylet with a beveled tip and a polycarbonate wing. The Discyphor Direct™ Inner Needle is manufactured from stainless steel and has a stainless steel stylet.

The Kyphon Discyphor Catheter System for the Functional Anaesthetic Discography™ Procedure, and its components, are intended for use in delivering either a single dose or continuous administration of radiopaque contrast, local anaesthetics, and/or saline solution to the intradiscal space. The Kyphon Discyphor Introducer Needle is intended for use to access the area adjacent to the intradiscal space for the purpose of facilitating sequential placement of the Discyphor Spinal Needle, Discyphor Catheter and Discyphor Guidewire into the intradiscal space. The Kyphon Discyphor Introducer Needle is intended to be used only with the Kyphon Discyphor Catheter System. The Kyphon Discyphor Spinal Needle is intended to access the nucleus of an intervertebral disc for the purpose of nerforming provocative discography and facilitating placement of the Discyphor Catheter and Guidewire into the intradiscal space. The Discyphor Spinal Needle can be used to deliver contrast, antibiotic, and/or saline into an intervertebral disc. The Kyphon Discyphor Spinal Needle is intended to be used only with the Kyphon Discyphor Catheter System.

The Discyphor" Catheter System is comprised of a Discyphor" Catheter with guidewire funnel, a Discyphor" Guidewire, a Discyphor" Introducer Needle, a Discyphor" Spinal Needle, a stopcock, syringes, catheter connectors and labels. The Discyphor Catheter is a micro-catheter with a flexible shaft and a balloon located near the distal tip. The metallic Discyphor Guidewire is .009" in diameter and is radiopaque when viewed using fluoroscopy. The stopcock retains pressure within the balloon when used in conjunction with the syringes. The catheter connectors are connected to the lumens of the Discyphor Catheter and provide access to the lumens. Labels are used to identify the solutions used during the procedure or to denote the level at which the Discyphor Catheter has been placed. The Discyphor Introducer Needle is designed specifically for use with the Discyphor Catheter System. The Discyphor Introducer Needle is stainless steel with a removable stainless steel stylet. The Discyphor Catheter is delivered through the Discyphor Introducer Needle and is tracked over the Discyphor Guidewire. The Discyphor" Spinal Needle is a standard stainless steel needle with a removable stainless steel stylet. The hubs of the needle and stylet are comprised of polymer.

The Functional Anaesthetic Discography (F.A.D.) Catheter System is intended for use in delivering either a single dose or continuous administration of a radiopaque contrast, local anaesthetics, and/or saline solution to the intradiscal space. The Functional Anaesthetic Discography (F.A.D.) Introducer Needle is intended for use to access the area adjacent to the intradiscal space for the purpose of facilitating placement of the F.A.D. Catheter and Guidewire into the intradiscal space.

The F.A.D. Catheter is a micro-catheter with a flexible shaft. The F.A.D. Catheter has a polymer balloon located near the distal tip. Once the F.A.D. Catheter is properly positioned, the balloon is inflated with a radiopaque contrast medium and assists in maintaining proper catheter placement during the procedure. The balloon is then deflated prior to removal of the F.A.D. Catheter. Two stainless steel tubes are contained inside the polymer shaft of the F.A.D. Catheter and serve as lumena. The inflation lumen is used for inflating and deflating the balloon and the guidewire / injection lumen is used for insertion of a guidewire and injection of radiopaque contrast, local anaesthetics, and/or saline solution. The proximal portion of both lumena are connected to the Portex® Epidural Catheter Connector Adapters during the procedure. There are two radiopaque markers on the F.A.D. catheter shaft, located proximally and distally within the balloon, allowing for radiographic positioning of the balloon. There are eight markers on the proximal end of the catheter which can be utilized to monitor stable catheter placement during the course of the procedure. The F.A.D. Introducer Needle is designed specifically for use with the F.A.D. Catheter System. The F.A.D. Introducer Needle is manufactured from stainless steel and has a stainless steel stylet. The F.A.D. Introducer Needle has a square cut distal tip with rounded edges. The stylet has a bevel tip. The F.A.D. Introducer Needle provides access to the area adjacent to the intradiscal space. The F.A.D. Catheter is delivered through the F.A.D. Introducer Needle and is tracked over the guidewire. The F.A.D. Catheter System is comprised of the following: One F.A.D. Catheter, One F.A.D. Introducer Needle, One Spinal Needle, One Guidewire, One Stopcock, One 3cc syringe, Two 1cc syringes, Two Catheter Connectors (toughy-borst adapters), One package of sterile labels. The F.A.D. Introducer Needle is also offered a la carte.

KyphX® Inflatable Bone Tamps are intended to be used as conventional bone tamps for the reduction of fractures and/or creation of a void in cancellous bone in the spine (including use during balloon kyphoplasty with KyphX® HV-R™ Bone Cement), hand, tibia, radius and calcaneus.

The KyphX® Inflatable Bone Tamps are the identified predicate devices. They are bone tamps with an inflatable component at the distal end. The products have the same technological characteristics and intended use as described for the predicates. Safety and effectiveness for use in kyphoplasty procedures is described in K033801.

KyphX® HV-R™ bone cement is indicated for the treatment of pathological fractures of the vertebral body due to osteoporosis, cancer, or benign lesions using a balloon kyphoplasty procedure. Cancer includes multiple myeloma and metastatic lesions, including those arising from breast or lung cancer, or lymphoma. Benign lesions include hemagioma and giant cell tumor.

Like the predicate devices, KyphX® HV-RTM Bone Cement is provided as a two-component system. The powder component consists of a PMMA copolymer (polymethyl methacrylate/methyl-methacrylate-styrene-copolymer) with barium sulfate as a radiopacifier and benzoyl peroxide as an initiator. The liquid component consists of methylmethacrylate monomer, with the addition of hydroquinone as a stabilizer and N.N-dimethyl-p-toluidine as a promoter. The powder and liquid components are mixed prior to use.

The KyphX® HV-R bone cement is indicated for the treatment of pathological fractures of the vertebral body due to osteoporosis using a kyphoplasty procedure.

Like the predicate device, KyphX® HV-R bonc coment is provided as a two-component system. The powder component consists of a PMMA copolymer (polymethyl methacrylate/methyl-methacrylate-styrene-copolymer) with barium sulfate as a radiopacifier and benzoyl pcroxide as an initiator. The liquid component consists ી methylmethacrylate monomer, with the addition of hydroquinone as a stabilizer and N,N-dimethyl-p-toluidine as a promoter. The powder and liquid components are mixed prior to use.

KyphX® Directional Inflatable Bone Tamps are intended to be used as conventional bone tamps for the reduction of fractures and/or creation of a void in cancellous bone in the spine, hand, tibia, radius and calcaneous.

The KyphX Directional Inflatable Bone Tamps (IBTs) are designed to compress cancellous bone and/or move cortical bone as they inflate. The inflatable component of the IBT is near the distal tip of the device. The catheter shaft contains an outer lumen for IBT inflation and a central lumen for a stylet to facilitate catheter introduction. At full inflation volume, the balloon design allows directionality of inflation with a maximum inflated diameter that is perpendicular to the catheter shaft. One design has a uniform balloon that is concentric to the catheter shaft. Another design has a non-uniform balloon that is tangential to the catheter shaft. Directionality of the balloon is indicated by external markers on the proximal Y-adapter component. Each design enables fluoroscopic visualization of the deflated balloon.

Kyphon Inflatable Bone Tamps are intended to be used as conventional bone tamps for the reduction for fractures and/or creation of a void in cancellous bone.

The Kyphon Inflatable Bone Tamp is a bone tamp with an inflatable component at the distal end. It is designed to compress cancellous bone and/or move cortical bone as it inflates. The Inflatable Bone Tamp has a nominal length of 40 cm and consists of a double lumen catheter shaft constructed from two coaxially aligned tubings. The inflatable component is mounted near the distal tip of the catheter tubing. Two radiopaque marker bands are attached to the inner tubing and located at the proximal and distal ends of the inflatable component. A side arm adapter attached to the proximal end of the Inflatable Bone Tamp provides access to the catheter lumens. Inflation and deflation are accomplished by connecting the side arm port with an inflation syringe. The straight arm port is continuous with the inner lumen of the catheter to allow placement of a removable stiffening stylet, which attaches to the Luer fitting of the straight arm.