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The Intelligent Implant Systems Mediant™ Anterior Cervical Plating System is intended for anterior cervical fixation for the following indications: degenerative disc disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.

The Intelligent Implant Systems' Mediant™ Anterior Cervical Plating System consists of bone screws (4.0 and 4.5 mm diameter) of various lengths and a series of plates for fusion of 1-. 2-. or 3- levels of the cervical spine (C2-T1). The device functions as follows: An appropriately sized plate is placed on the anterior aspect of the vertebral body of the cervical spine by inserting either a 4.0 mm or a 4.5 mm diameter bone screw through the cephalad and caudad holes and into the vertebral body. The device improves stability of the spine while supporting fusion. The Mediant™ cervical plates are provided in multiple lengths from 19 mm (one-level) through 78 mm (three-level) for one-, two- and three-level fusions. The thickness of all plates is 2.2 mm and the width is 19.0 mm. All plates interface with the same cervical bone screws. which are either 4.0 mm diameter or 4.5 mm diameter. The bone screws can best be described as semi-constrained, but can be inserted at any angle (within a ±18° angular variation) to the plate. A slider mechanism then locks the bone screws to the plate at the angle of insertion using the supplied locking pliers. The bone screw will remain fixed at the angle of insertion unless bone resorption results in high loading levels on the bone screws. If this occurs, due to the polyaxiality of the screw, the screw will re-position itself and re-lock at the new angle. All implant components of the Mediant™ Anterior Cervical Plating system are manufactured from Ti-6Al-4V ELI alloy, conforming to ASTM F136.

The Revolution™ Spinal Fixation System is intended for pedicle screw fixation of the noncervical, posterior spine in order to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: (1) degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), (2) spondylolisthesis, (3) trauma (i.e., fracture or dislocation), (4) spinal stenosis, (5) deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), (6) tumor, (7) pseudoarthrosis, (8) failed previous fusion.

The previously cleared Intelligent Implant Systems' Revolution™ Spinal Fixation System consists of monoaxial bone screws of various lengths and diameters and a series of connector assemblies for connecting the bone screws. The standard (one level) Revolution™ Connectors are provided in various lengths and are used to connect the pedicle screws and create a rigid structure. To allow for variation in screw placement, each end of the connector allows for angular compensation. One end allows for full polyaxial angulation, similar to a typical polyaxial screw. The other end has a pivoting-slide that allows for angulation in only one plane along the long axis of the Connector while also sliding within an opening in the Connector. As the distance between two screws is always variable, the slide allows the Connector to compensate for this difference, minimizing inventory. In addition, the Connectors have a threaded locking nut built into each end and each nut fits over the top of a bone screw post. These locking nuts are turned clockwise to tighten. A calibrated torque wrench provides the correct setting for locking the nuts on the bone screw post with sufficient force. The system can be unlocked, if necessary, by turning the locking nuts counterclockwise. To allow for multiple level fusions, four additional components were added to the system (K160216): 1) Transition Bone Screws, 2) Transition Connectors, 3) Two-Post Connectors, and 4) Two-Post Bone Screws. These components provide two connector attachment posts with a single bone screw, which allows the attachment of two connectors (one superior, one inferior) to a single level of the spine. In the case of the Transition Connector, the Transition Bone Screw includes a connector attachment post. This 510(k) submission adds two types of components to the system: 1) Two-Level Connectors, and 2) Two-Level Bone Screws. These components, when utilized with the previously cleared, standard Revolution™ connectors and standard bone screws, allow stabilization of two levels of the spine. These new Two-Level components allow fusion of two spinal levels when the patient's inter-pedicular distances are very short, by allowing attachment of two connector interfaces to a single bone screw. Like the previously cleared Revolution™ bone screws, the Two-Level Bone Screws are available in diameters of 4.5 mm - 7.5 mm, and in lengths from 25 mm to 55 mm. All screw diameter sizes except for the 4.5mm are cannulated for use with a 1.4 mm k-wire. The Two-Level Bone Screws have a standard thread for interfacing bone and a partially threaded post designed to engage a standard (one level) connector and a Two-Level Connector. The Two-Level Connector uses the same technology (the pivoting-slide and the spherical bearing), and has a stepped central plate. The step in the plate allows two connectors to stack on top of each other, thus requiring less horizontal space to attach two connectors. All implant components of the Revolution™ Spinal Fixation System, including the additional components, are manufactured from Ti-6Al-4V ELI alloy, conforming to ASTM F136.

The Revolution™ Spinal Fixation System is intended for pedicle screw fixation of the noncervical, posterior spine in order to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: (1) degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), (2) spondylolisthesis, (3) trauma (i.e., fracture or dislocation), (4) spinal stenosis, (5) deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), (6) tumor, (7) pseudoarthrosis, (8) failed previous fusion.

The Intelligent Implant Systems' Revolution™ Spinal Fixation System consists of monoaxial bone screws of various lengths and diameters and a series of connector assemblies for connecting the bone screws. This 510(k) submission adds four types of components to the system: 1) Transition Connector, 2) Transition Bone Screws, 3) Two-Post Connector, and 4) Two-Post Bone Screws. These components, when utilized with the existing standard Revolution™ connectors and standard bone screws, allow stabilization of multiple levels of the spine. Like the existing bone screws, the Transition and Two-Post bone screws are available in diameters of 4.5 mm - 7.5 mm, and in lengths from 25 mm to 55 mm. All screw diameter sizes except for the 4.5mm are cannulated for use with a 1.4 mm k-wire. The Transition Bone Screws and Two-Post Bone Screws have a standard thread for interfacing bone and a partially threaded post designed to engage the Revolution™ Connectors. The Transition Connector and Two-Post Connector effectively create two threaded posts from a single bone screw. These threaded posts are utilized to connect to the Revolution™ Connectors. The standard Revolution™ Connectors are provided in various lengths and are used to connect the pedicle screws and create a rigid structure. To allow for variation in screw placement, each end of the connector allows for angular compensation. One end allows for full polyaxial angulation, similar to a typical polyaxial screw. The other end has a pivoting-slide that allows for angulation in only one plane along the long axis of the Connector while also sliding within an opening in the Connector. As the distance between two screws is always variable, the slide allows the Connector to compensate for this difference, minimizing inventory and eliminating the need to cut spinal rods. In addition, the Connectors have a threaded locking nut built into each end and each nut fits over the top of a bone screw post. These locking nuts are turned clockwise to tighten. A calibrated torque wrench provides the correct setting for locking the bone screw post with sufficient force. The system can be unlocked, if necessary, by turning the locking nuts counterclockwise. All implant components of the Revolution™ Spinal Fixation System. including the new multi-level components, are manufactured from Ti-6Al-4V ELI alloy, conforming to ASTM F136.

The Revolution™ Spinal Fixation System is intended for pedicle screw fixation of the noncervical posterior spine in order to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: (1) degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), (2) spondylolisthesis, (3) trauma (i.e., fracture or dislocation), (4) spinal stenosis, (5) deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), (6) tumor, (7) pseudoarthrosis, (8) failed previous fusion.

The Intelligent Implant Systems' Revolution™ Spinal Fixation System consists of monoaxial bone screws of various lengths and diameters and a series of connector assemblies for connecting the bone screws. The Revolution™ Bone Screws have a standard thread for interfacing bone and a partially threaded post designed to engage the Revolution™ Connectors. Screws are available in 4.5mm major diameter and lengths from 25mm to 50mm and 5.5mm, 6.5mm, and 7.5mm major diameters and lengths from 25mm to 55mm. All screw diameter sizes except for the 4.5mm are cannulated for use with a 1.4 mm k-wire. To allow the surgeon to determine the height of the connector relative to the bone, screws with extended non-threaded collars are provided. These extended collars effectively provide built in spacers that prevent the bone screw from being driven too deep and control the overall height of the completed assembly. The Revolution™ Connectors are provided in various lengths and are used to connect the pedicle screws and create a rigid structure. To allow for variation in screw placement, each end of the connector allows for angular compensation. One end allows for full polyaxial angulation, similar to a typical polyaxial screw. The other end has a pivoting-slide that allows for angulation in only one plane along the long axis of the Connector while also sliding within an opening in the Connector. As the distance between two screws is always variable, the slide allows the Connector to compensate for this difference, minimizing inventory and eliminating the need to cut spinal rods. In addition, the Connectors have a threaded locking nut built into each end and each nut fits over the top of a bone screw post. These locking nuts are turned clockwise to tighten. A calibrated torque wrench provides the correct setting for locking the nuts on the bone screw post with sufficient force. The system can be unlocked, if necessary, by turning the locking nuts counterclockwise. All implant components of the Revolution™ Spinal Fixation System are manufactured from Ti-6Al-4V ELI alloy, conforming to ASTM F136.

The Marauder™ Cervical-Thoracic Spinal Fixation System implants are intended to be used as a temporary construct that assists in normal healing and are not intended to replace normal body structures. The system is intended to stabilize the spinal operative site during posterior fusion procedures, attaching to the spine by means of hooks and screws joined with spinal rods and should be removed after fusion. The Marauder™ Cervical-Thoracic Spinal Fixation System is intended to promote fusion of the cervical and thoracic spine (C1-T3) for the following conditions: degenerative disc disease (neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies); spondylolisthesis; spinal stenosis; trauma (fracture/dislocation); failed previous fusion; and/or tumors. The hooks and rods are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (CI-T3) spine. The use of screws is limited to placement in TI-T3 vertebrae for treating thoracic conditions only. Screws.are not intended to be placed in the cervical spine.

The Marauder™ Cervical-Thoracic Spinal Fixation System consists of a polyaxial bone screw with a spherical-shape head, and a standard thread for interfacing bone. Screws are available in 3.5 mm and 4.0 mm diameters and lengths from 10mm to 30mm. In addition to polyaxial screws, hooks are provided for use in the cervical and thoracic spine. Three hook geometry variations are offered with the Marauder™ Cervical-Thoracic Spinal Fixation System. The hooks use the same rod locking means as the polyaxial screw implants. Titanium rods are provided in various lengths and are used to connect pedicle screws and create a rigid structure. The rods are connected to the implants by interference with the rod saddle and held into position by the locking caps. All implant components of the Marauder™ Cervical-Thoracic Spinal Fixation System are manufactured from Ti-6Al-4V alloy, conforming to ASTM F136.

The ACTIVE TM Screw Bone Screw is intended for implantation into prepared bone during orthopaedic surgery when the surgeon determines the need for additional fixation: bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation, appropriate for the size of the device. The ACTIVE™ Screw Bone Screw is indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation, appropriate for the size of the device.

The ACTIVE ™ Screw Bone Screws subjected to this premarket notification are 4.5 mm diameter screws available in 5 mm length increments from 20 to 50 mm. The screws are manufactured from titanium alloy and have an expandable thread crest. The implants are single use only devices. The ACTIVE ™ Screw Bone Screw consists of a screw shank in conjunction with a spiral helical thread crest component. With the spiral helical thread component, the screw has the ability to expand an additional 1 mm after implantation. The ACTIVE TM Screw Bone Screw is made of wrought titanium 6AI-4V ELI (ASTM F136) and is available in a 4.5 mm diameter size from 20 mm to 50 mm and will be provided non-sterile, and is to be steam sterilized by the end user. Resterilization of screws upon contamination is not recommended.