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It is intended that this device, in any system configuration be removed after development of solid fusion mass. Hook component indications are limited to T7-L5. Sacral screw indications are limited to the sacrum only. 1) The ZODIAC Polyaxial Pedicle Screw System, when used as a hook and sacral screw fixation system (nonpedicle screw) is intended for: a. Patients having fractures of the thoracic and lumbar spine. b. Patients having deformity (i.e., idioscoliosis, neuromuscular scoliosis, or kyphoscoliosis with associated paralysis or spasticity). c. Patients having spondylolisthesis (i.e., isthmic spondylolisthesis, degenerative spondylolisthesis, and acute pars fracture allowing spondylolisthesis). 2) The ZODIAC Polyaxial Pedicle Screw System, when used as a pedicle screw system in the thoraco-lumbo-sacral region of the spine is intended for degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor and failed previous fusion (pseudoarthrosis). 3) In addition, the ZODIAC Polyaxial Pedicle Screw System, when used as a pedicle screw fixation system is intended for: a. Patients receiving only autogenous bone graft. b. Patients having the device fixed or attached to the lumbar and sacral spine and having severe spondylolisthesis grade 3 or 4 at the fifth lumbar-first sacral (L5-S1) vertebral joint. 4) The ZODIAC Polyaxial Pedicle Screw System, when used as a laminar hook and bone screw system is intended for: a. Patients having fractures of thoracic and lumbar spine. b. Patients having thoracolumbar deformity (i.e., idioscoliosis, neuromuscular scoliosis, or kyphoscoliosis with associated paralysis or spasticity). c. Patients having spondylolisthesis (i.e., isthmic spondylolisthesis, degenerative spondylolistheses and acute pars fracture allowing spondylolisthesis).

The ZODIAC Polyaxial Pedicle Screw System is comprised of various types and sizes of implantable components that are assembled to create a rigid spinal construct. System components are manufactured from titanium alloy, Ti6Al-4V ELI (ASTM F 136). System rods are available in titanium alloy or commercially pure titanium, CP Grade 4 (ASTM G67). The ZODIAC Polyaxial Pedicle Screw System is designed to facilitate optimal screw and rod placement.

The Alpha Mirage® Top Tightening Spinal System is intended for use as a posterior spinal fixation device to aid in the surgical correction of various spinal deformities and pathologies in the thoraco-lumbo-sacral portion of the spine. It is intended to provide stabilization during the development of fusion utilizing a bone graft. Specific indications for the Alpha Mirage® Top Tightening Spinal System are dependent in part on the configuration of the assembled device and the method of attachment to the spine and are listed in Indications for Use Statement. It is intended that this device, in any system configuration be removed after development of solid fusion mass. Hook component indications are limited to T7-L5. Sacral screw indications are limited to the sacrum only. 1) The Alpha Mirage® Top Tightening Spinal System, when used as a hook and sacral screw fixation system (nonpedicle screw) is intended for: a. Patients having fractures of the thoracic and lumbar spine. b. Patients having deformity (i.e., idioscoliosis, neuromuscular scoliosis, or kyphoscoliosis with associated paralysis or spasticity). c. Patients having spondylolisthesis (i.e., isthmic spondylolisthesis, degenerative spondylolisthesis, and acute pars fracture allowing spondylolisthesis). 2) The Alpha Mirage® Top Tightening Spinal System, when used as a pedicle screw system in the thoraco-lumbo-sacral region of the spine is intended for degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor and failed previous fusion (pseudoarthrosis). 3) In addition, the Alpha Mirage® Top Tightening Spinal System, when used as a pedicle screw fixation system is intended for: a. Patients receiving only autogenous bone graft. b. Patients having the device fixed or attached to the lumbar and sacral spine and having severe spondylolisthesis grade 3 or 4 at the fifth lumbar-first sacral (L5-S1) vertebral joint. 4) The Alpha Mirage® Top Tightening Spinal System, when used as a laminar hook and bone screw system is intended for: a. Patients having fractures of thoracic and lumbar spine. b. Patients having thoracolumbar deformity (i.e., idioscoliosis, neuromuscular scoliosis, or kyphoscoliosis with associated paralysis or spasticity). c. Patients having spondylolisthesis (i.e., isthmic spondylolisthesis, degenerative spondylolistheses and acute pars fracture allowing spondylolisthesis).

The Alpha Mirage® Top Tightening Spinal System is a spinal fixation system comprised of various types and sizes of components that are implanted via a posterior surgical approach and assembled to create a spinal construct. Like most other posterior spinal fixation systems, the Alpha Miraqe® Top Tightening Spinal System is comprised of 1) bone screws and hooks for attachment to the spine, 2) longitudinal rods that are attached to the bone screws and hooks directly/indirectly by means of lateral connectors, and that transmit loads across the pathologic segments of the spine, and 3) optional transverse connecting elements that link the two longitudinal rods for added construct stability. The purpose of this 510(k) is to provide for commercially pure titanium rods, which allows surgeons to manipulate the rod prior to implantation without compromising the structural strength of the construct.

It is intended that this device, in any system configuration be removed after development of solid fusion mass. Hook component indications are limited to T7-L5. Sacral screw indications are limited to the sacrum only. 1) The Alpha Mirage® Top Tightening Spinal System, when used as a hook and sacral screw fixation system (nonpedicle screw) is intended for: a. Patients having fractures of the thoracic and lumbar spine. b. Patients having deformity (i.e., idioscoliosis, neuromuscular scoliosis, or kyphoscoliosis with associated paralysis or spasticity). c. Patients having spondylolisthesis (i.e., isthmic spondylolisthesis, deqenerative spondylolisthesis, and acute pars fracture allowing spondylolisthesis). 2) The Alpha Mirage® Top Tightening Spinal System, when used as a pedicle screw system in the thoraco-lumbo-sacral region of the spine is intended for degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumore and failed previous fusion (pseudoarthrosis). 3) In addition, the Alpha Mirage® Top Tightening Spinal System, when used as a pedicle screw fixation system is intended for: a. Patients receiving only autogenous bone graft. b. Patients having the device fixed or attached to the lumbar and sacral spine and having severe spondylolisthesis grade 3 or 4 at the fifth lumbar-first sacral (L5-S1) vertebral joint. 4) The Alpha Mirage® Top Tightening Spinal System, when used as a laminar hook and bone screw system is intended for: a. Patients having fractures of thoracic and lumbar spine. b. Patients having thoracolumbar deformity (i.e., idioscoliosis, · neuromuscular scoliosis, or kyphoscoliosis with associated paralysis or spasticity). c. Patients having spondylolisthesis (i.e., isthmic spondylolisthesis, degenerative spondylolistheses and acute pars fracture allowing spondylolisthesis).

The Alpha Mirage® Top Tightening Spinal System is a spinal fixation system comprised of various types and sizes of components that are implanted via a posterior surgical approach and assembled to create a spinal construct. Like most other posterior spinal fixation systems, the Alpha Mirage® Top Tightening Spinal System is comprised of 1) bone screws and hooks for attachment to the spine, 2) longitudinal rods that are attached to the bone screws and hooks directly/indirectly by means of lateral connectors, and that transmit loads across the pathologic segments of the spine, and 3) optional transverse connecting elements that link the two longitudinal rods for added construct stability.

The Deltaloc Anterior Cervical Plate System is indicated for use in the anterior cervical spine (C2-C7); patients with trauma (including fractures), spondylolisthesis, degenerative spondylosis, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spinal stenosis, and tumors.

The Deltaloc Anterior Cervical Plate System consists of plates and screws that are used for attachment to the anterior cervical spine. Plates are offered in a variety of sizes with varying numbers of screw holes to accommodate single to quadruple level fusions. Plates are shaped with both radial and lordotic curvature and contain a deformable tab at each screw hole to capture the screws to the plate, preventing screw digression. Screws are offered in two diameters and four lengths per diameter. All screws are also available so that their angle relative to the plate is fixed or variable. The plates of the Deltaloc Anterior Cervical Plate System are manufactured from commercially pure titanium and the screws are manufactured from titanium alloy (Ti-6Al-4V).

The Alphatec External Fixation System is indicated for limb salvage from traumatic injury; fracture treatment (i.e., long bone fracture, including the tibia, femur, humerus, radius, and ulnar bones); reconstruction of extremities with deformity and dysfunction; limb lengthening; arthrodesis; and pelvic fractures.

The Alphatec External Fixation System Compression/Distraction (CD) Rod consists of a CD rod that is available in two lengths and a CD rod to rod connector. These components are designed to be used in conjunction with the Alphatec External Fixation System and the Alphatec Wire External Fixation System which were the subject of prior premarket notifications. The additional use of the CD rod with the systems listed adds the capabilities of limb lengthening during fracture fixation. The CD rod and CD rod to rod connector are manufactured from titanium alloy (Ti-6Al-4V).

The Pylon Intramedullary Nail System is indicated for internal fixation of tibial or femoral fractures including low subtrochanteric fractures, transverse fractures, oblique and spiral fractures, segmental fractures, comminuted fractures, high supracondylar and spiral fractures with bone loss, stabilization for bone transport or lengthening and shortening, open fractures, corrective osteotomies, pathologic fractures, pseudoarthrosis of the bone shaft, nonunions, malunions, metaphyseal/diaphyseal junction fractures, and acute bone lengthening and shortening.

The Pylon Intramedullary Nail System consists of intramedullary rods and screws for fixation inside the canal of the tibia or femur. The rods are cylindrically shaped and either made of a solid or cannulated construct, depending on the outer diameter of the rod. Rods are available in a variety of diameters and lengths and have holes located in the proximal and distal ends for fixation to bone by means of bone screws. Bone screws are also available in a multitude of diameters and lengths. An end cap is available that screws into the proximal end of the nails to prevent bone ingrowth which may hamper the attachment of extraction instrumentation. All components of the Pylon Intramedullary Nail System are manufactured from titanium alloy (Ti-6Al-4V).

External Fixation is useful in many areas of orthopedic surgery. Following are the major categories of application: - 1) Limb salvage from traumatic injury. - 2) Fracture treatment (i.e. long bone fracture, including the tibia, femur, humerous, radius, and ulnar bones). - 3) Reconstruction of extremities with deformity and dysfunction. 4) Arthrodesis. The surgeon must carefully evaluate the purpose for external fixation in the individual patient if the treatment is to be successful. Consideration should be given to the following factors necessary for the successful application of an external fixator. Fracture osteotmy stability, soft tissue viability, adjacent function or injury, and functional demands of the patient.

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