Search Results

The Trivergent Spinal Fixation System is intended to provide immobilization of a single spinal segment in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of lumbar and sacral spine from L2-S1: degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spinal stenosis; and failed previous fusion.

The Trivergent Spinal Fixation System is a pedicle screw system intended to stabilize and immobilize the L2-S1 spinal segments as an adjunct to fusion. The system includes a variety of screws and plates along with guides, guidewires, drills, drivers, handles, and tans. The Trivergent Spinal Fixation System plates and screws are available in a variety of geometries to accommodate various patient anatomies. The Trivergent screws come in lengths from 45mm to 60mm, and the Trivergent plates come in angles from 60° to 75°. The Trivergent Spinal Fixation System implants and instruments are provided non-sterile and are to be sterilized by the end user. The Trivergent Spinal Fixation System implants are machined from Ti-6A1-4V ELI per ASTM F136.

The Luna XD Ti Interbody Fusion System consists of the Luna XD Ti Implant and associated accessories. This system is indicated for spinal fusion procedures in skeletally mature patients with symptomatic degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to grade I spondylolisthesis or retrolisthesis at the involved level(s). The Luna XD Ti Interbody Fusion is to be used with autogenous bone graft and/or allogence bone graft composed of cancellous bone graft to facilitate fusion. Patients receiving the device should have had at least six months of nonoperative treatment prior to receiving the Luna XD Ti Implant. The Luna XD Ti Interbody Fusion System is to be used with supplemental fixation.

The Benvenue Luna XD Ti Interbody Fusion System consists of the Luna XD Ti Implant and associated accessories set of disposable accessories for use in lumbar fusion procedures to treat degenerative disc disease. The proposed indications for use for the Luna XD Ti Interbody Fusion System are identical to the primary predicate device. The Luna XD Ti Implant is provided pre-loaded and sterile within a single-use Insertion Tool. The Luna XD Ti Implant is an assembly of three (3) PEEK components referred to as the Top, Middle and Bottom, similar to the Luna 3D Gen2. Additionally, a Nitinol Spine is inserted into the middle component to retain its normally closed shape configuration. And finally, the outer top and bottom surfaces of the implant XD Ti have a commercially pure (Cp) Ti metallic powder. The final components have radiopaque tantalum markers for fluoroscopic visibility. The outer surfaces of the Top and Bottom components have teeth in addition to the already rough surface created by the Ti coating, which are designed to enhance the implant's resistance to expulsion. Upon insertion of the outer components, the middle component is inserted to expanded into its ultimate height. The central cavity of the implant accommodates placement of autogenous bone graft and/or allogenic bone graft composed of cancellous and/or corticocancellous bone graft through a graft window. The Luna XD Ti Implant is manufactured from polyetheretherketone (Evonik VESTAKEEP i4R; ASTM F2026), Nitinol (nickel titanium alloy; ASTM F2063), tantalum (ASTM F560) and commercially pure (Cp) Ti metallic powder coating layer (ASTM F 1580). The Luna XD Ti Implant is available in heights ranging from 10mm to 14mm with 2mm increments and a 6° lordotic angle and from 12mm with 2mm increments and a 12° lordotic angle. A series of vertically oriented slots allows the device to flex and enables it to be inserted from a straight cannula and then attain a closed, fixed, and circular shape upon being placed into the disc space with a bone graft pocket. Teeth engage the implant into the adjacent endplates. In addition, the outer top and bottom surfaces of the implant XD Ti have a commercially pure (Cp) Ti metallic powder conforming to ASTM F1580 with a specified grain size and morphology. This additional titanium coating offers initial stability due to increased surface roughness and possibly also long-term stability due to bony ingrowth created from osteoconductive microenvironment on the device surface. The Luna XD Ti Implant that is the subject of this 510(k) is manufactured from polyetheretherketone (Evonik VESTAKEEP i4R; ASTM F2026), Nitinol (nickel titanium alloy; ASTM F2063), tantalum (ASTM F560) and commercially pure (Cp) Ti metallic powder coating layer (ASTM F 1580). This 510(k) is submitted in support of the additional surface coating to an existing Device cleared under K183560.

The Luna 3D GEN2 Interbody Fusion System consists of the Luna 3D Implant and associated accessories. This system is indicated for spinal fusion procedures in skeletally mature patients with symptomatic degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to grade I spondylolisthesis or retrolisthesis at the involved level(s). The Luna 3D GEN2 Interbody Fusion System is to be used with autogenous bone graft and/or allogenic bone graft composed of cancellous and/or corticocancellous bone graft to facilitate fusion. Patients receiving the device should have had at least six months of nonoperative treatment prior to receiving the Luna 3D GEN2 Implant. The Luna 3D GEN2 Interbody Fusion System is to be used with supplemental fixation.

The Benvenue Luna 3D GEN2 Interbody Fusion System consists of the Luna 3D GEN2 Implant and associated accessories set of disposable and re-usable accessories for use in lumbar fusion procedures to treat degenerative disc disease. The proposed indications for use for the Luna 3D GEN2 Interbody Fusion System are identical to the primary predicate device. The Luna 3D GEN2 Implant is provided pre-loaded and sterile within a single-use Insertion Tool. The Luna 3D GEN2 Implant is available in heights ranging from 10mm to 14mm with 2mm increments and a 6° lordotic angle and from 12mm with 2mm increments and a 12° lordotic angle. A series of vertically oriented slots allows the device to flex and enables it to be inserted from a straight cannula and then attain a closed, fixed, and circular shape upon being placed into the disc space. Once the implant is in the desired position, the device is expanded into its ultimate height and forming a bone graft pocket. Teeth on the outer surfaces of the top and bottom components engage the implant into the adjacent endplates. The Luna 3D GEN2Implant that is the subject of this 510(k) is manufactured from polyetheretherketone (VESTAKEEP i4R, conforming to ASTM F2026), nitinol wire (superelastic alloy SE508, conforming to ASTM F2063) and tantalum rod conforming to ASTM F560. This 510(k) was submitted in support of the Generation 2 device.

The Luna 3D Interbody Fusion System consists of the Luna 3D Implant and associated accessories. This system is indicated for spinal fusion procedures in skeletally mature patients with symptomative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to grade I spondylolisthesis or retrolisthesis at the involved level(s). The Luna 3D Interbody Fusion System is to be used with autogenous bone graft and/or allogenic bone graft composed of cancellous and/or corticocancellous bone graft to facilitate fusion. Patients receiving the device should have had at least six months of nonoperative treatment prior to receiving the Luna 3D Implant. The Luna 3D Interbody Fusion System is to be used with supplemental fixation.

The Benvenue Luna 3D Interbody Fusion System consists of the Luna 3D Implant and associated accessories set of disposable accessories for use in lumbar fusion procedures to treat degenerative disc disease. The proposed indications for use for the Luna 3D Interbody Fusion System are identical to predicate interbody lumbar cages. The Luna 3D Implant is provided pre-loaded and sterile within a single-use Insertion Tool. The Luna 3D Implant is available in heights ranging from 8mm to 15mm in 1mm increments. A series of vertically oriented slots allows the device to flex and enables it to be inserted from a straight cannula and then attain a closed, fixed, and circular shape upon being placed into the disc space with a bone graft pocket. Teeth engage the implant into the adjacent endplates. The Luna 3D Implant is manufactured from polyetheretherketone (PEEK Optima LT-1 or Evonik VESTAKEEP i4R), stainless steel, tantalum, and silicone lubricant (NuSil MED-360).

The Luna 360 Interbody Fusion System consists of the Luna 360 Implant and associated accessories. This system is indicated for spinal fusion procedures in skeletally mature patients with symptomatic degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to grade I spondylolisthesis or retrolisthesis at the involved level(s). The Luna 360 System is to be used with autogenous bone graft. Patients receiving the device should have had at least six months of nonoperative treatment prior to receiving the Luna 360 Implant. The Luna 360 System is to be used with supplemental fixation.

The Benvenue Luna 360 System consists of the Luna 360 Implant and associated accessories set of disposable accessories for use in lumbar fusion procedures to treat degenerative disc disease. The proposed indications for use for the Luna 360 System are identical to predicate interbody lumbar cages. The Luna 360 Implant is provided pre-loaded and sterile within a single-use Insertion Tool. The Luna 360 Implant is available in heights ranging from 8mm to 13mm in 1mm increments. A series of vertically oriented slots allows the device to flex and enables it to be inserted from a straight cannula and then attain a closed, fixed, and circular shape upon being placed into the disc space with a bone graft pocket. Teeth engage the implant into the adjacent endplates. The Luna 360 Implant is manufactured from polyetheretherketone (PEEK Optima LT-1), stainless steel, tantalum, and silicone lubricant (NuSil MED-360).

The Kiva VCF Treatment System is indicated for use in the reduction and treatment of spinal fractures in the thoracic and/or lumbar spine from T6-L5. It is intended to be used in combination with the Benvenue Vertebral Augmentation Cement Kit.

The Kiva® VCF Treatment System is provided as a sterile, single use, implantable device which may be used in percutaneous procedures for the reduction and treatment of spinal fractures. The device consists of an implant, a deployment system for the implant, and a set of accessory access instruments. The deployment system component is a single-use, non- implantable device that is used to properly position and deliver the implant. It consists of a nitinol Kiva Coil, which is guided through a deployment cannula into the bone via a hand- operated mechanism. The Kiva Implant, made from PEEK Optima with barium sulfate for radiopacity, is guided over the nitinol Kiva Coil. As the Kiva Implant is pushed over the Kiva Coil, it reduces the fracture via height distraction of the vertebral body. Up to 5 loops of implant may be deployed, corresponding with a maximum height of 15mm. Once the Implant is placed into the vertebral body, PMMA bone cement is deployed into the Kiva Implant. The Kiva Implant contains the PMMA bone cement and helps extravasation. A collection of manual surgical orthopedic instrumentation (Class I needles, stylets, cannulas) is used to gain access to the vertebral body at the start of the procedure, then again later for bone cement deployment. Other instruments are optional for the physician and not provided as part of the Kiva® VCF Treatment System including a Bone Drill, a Bone Biopsy Needle and Kiva Pilot.

The Kiva® VCF Treatment System is indicated for use in the reduction and treatment of spinal fractures in the thoracic and/or lumbar spine from T6-L5. It is intended to be used in combination with the Benvenue Vertebral Augmentation Cement Kit.

The Kiva® VCF Treatment System is provided as a sterile, single use, implantable device which may be used in percutaneous procedures for the reduction and treatment of spinal fractures. The device consists of an implant, a deployment system for the implant, and a set of accessory access instruments. The deployment system component is a single-use, nonimplantable device that is used to properly position and deliver the implant. It consists of a nitino! Kiva Coil, which is guided through a deployment cannula into the bone via a hand operated mechanism. The Kiva Implant, made from PEEK Optima with barium sulfate for radiopacity, is guided over the nitinol Kiva Coil. As the Kiva Implant is pushed over the Kiva Coil, it reduces the fracture via height distraction of the vertebral body. Once the Implant is placed into the vertebral body. PMMA bone cement is deployed into the Kiva Implant. The Kiva Implant contains the PMMA bone cement and helps minimize posterior extravasation. A collection of manual surgical orthopedic instrumentation (Class I needles, stylets, cannulas) is used to gain access to the vertebral body at the start of the procedure, then again later for bone cement deployment.

The Benvenue VCF Osteo Coil System is indicated for the treatment of pathological compression fractures of the vertebral body that may result from osteoporosis, benign lesions, and/or malignant lesions, by creating channels in the existing spinal bone structure for the flow of polymethylmethacrylate bone cement (PMMA).

The Benvenue VCF Osteo Coil System is packaged as a single-use, sterile, non-implantable device. It is a surgical instrument designed to be used in percutaneous applications, for the creation of channels within the existing spinal bone structure for the flow of polymethylmethacrylate bone cement (PMMA). The Benvenue VCF Osteo Coil System consists of three primary components: Nitinol Osteo Coil, Deployment Cannula with PEEK liner, and Handle. The nitinol Osteo Coil is pre-set into a loop shape and can be temporarily straightened into a cannula for deployment into cancellous bone. Once positioned in the cancellous bone, the Osteo Coil is advanced forward out of the cannula. The surgeon controls the amount of Osteo Coil deployment with the use of the handle, which allows for incremental deployment and directional control. Upon exiting the Osteo coil regains its loop shape as it channels through the cancellous bone. The device is available in two sizes. This system does not include the bone cement.