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The Apollo Spine Venus Facet Screw System is intended to stabilize the spine as an aid to fusion through bilateral immobilization of the facet joints, with or without bone graft, at single or multiple levels, from C2 to S1 for 4.5mm and 5.5 mm screws. For transfacet fixation the screws are inserted posteriorly through the superior side of the facet, across the facet joint, and into the pedicle. For translaminar facet fixation, the screws are inserted posteriorly through the lateral aspect of the spinous process, through the lamina, through the superior side of the facet, across the facet joint, and into the pedicle. The Apollo Venus Facet System is indicated for treatment of any or all of the following: - Pseudoarthrosis and failed previous fusions which are symptomatic or which may cause secondary instability or deformity - Spondylolisthesis - Spondylolysis - Degenerative disk disease (DDD) as defined by neck and/or back pain of discogenic origin as confirmed by radiographic studies - Degeneration of the facets with instability - Trauma including spinal fractures and/or dislocations

The Venus Facet Screw System consists of two separate diameter screws and is provided in variable lengths for cervical and lumbar use. The screws have small fenestration in the threaded portion. The system includes a cervical and lumbar facet screws. The system screws provide fixation and are designed to connect vertebral facets, resulting from such causes as degenerative disease and/or trauma. These screw kits are considered a 'family' product line with sizes based on the anatomical variations of the patient's facets. The materials contained in the device include implant grade titanium alloy, Ti-6AI-4V (ELI) per ASTM F-136. The device is sold non-sterile and is to be sterilized at the end use facility by steam sterilization. The Venus Facet Screw System is a single use device.

The Zenith Pedicle System is intended 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: degenerative spondylolisthesis with objective evidence of neurologic impairment, trauma (i.e., fracture or dislocation), deformities or curvatures ( i.e., scoliosis, kyphosis, and/or lordosis), spinal tumor, and failed previous fusion (pseudarthrosis). In addition, this device is a pedicle screw system indicated for the treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3-S1) with removal of implants after the attainment of a solid fusion.

The Apollo Spine Zenith Pedicle Screw System consists of a variety of rods and screws, which can be rigidly locked into a variety of configurations, with each construct being tailor made for the individual case. Multi axial implant screws are supplied in 5.5mm, 6.5mm, 7.5mm and 8.5mm diameter sizes. All sizes are able to receive 5.5 mm connecting rods only. All implant components are fabricated from medical grade titanium alloy (TI-6AI-4V ELI) conforming to ASTM F136 or equivalent. The Apollo Spine Zenith Pedicle Screw System is a temporary implant system, intended to be removed after solid fusion has occurred. Implant components should not be used with components from any other system or manufacturer. As with all orthopedic implants, components should not be reused.

When used as an Intervertebral Body Fusion System: The Eclipse Vertebral Spacer System-Lumbar is indicated for intervertebral body fusion in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine with accompanying radicular symptoms at one disc level from L2-S1. DDD is defined as pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should have completed six weeks of non-operative treatment. The Eclipse Vertebral Spacer System-Lumbar implants are to be used with autogenous bone graft. Supplemental fixation is required. When used as a Vertebral Body Replacement Device: The Eclipse Vertebral Spacer System-Lumbar when used as a vertebral body replacement is intended for use for partial and total replacement of a vertebral body that has been resected or excised due to tumor and/or trauma/fracture. The device is intended for use as a partial vertebral body replacement in the thoracolumbar spine at a single level from TI-L5. These devices are intended to be used with autogenous bone graft. Supplemental fixation is required.

The Eclipse Vertebral Spacer-Lumbar acts as a spacer to maintain proper Intervertebral and vertebral body spacing and angulation. The Eclipse Vertebral Spacer is manufactured from PEEK, unalloyed titanium, and Ti6Al4V titanium alloy. The device contains serrations on the superior and inferior surfaces and includes positioning pins that are advanced during placement. Pins are used to aid in the positioning and to allow for radiographic confirmation during device placement.

The Eclipse Vertebral Spacer System-Cervical is indicated for intervertebral body fusion in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level from C2 to T1. DDD is defined as pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should have completed six weeks of non-operative treatment. The Eclipse Vertebral Spacer System-Cervical implants are to be used with autogenous bone graft. Supplemental fixation is required.

The Eclipse Vertebral Spacer-Cervical acts as a spacer to maintain proper Intervertebral and vertebral body spacing and angulation. The Eclipse Vertebral Spacer is manufactured from PEEK, unalloyed titanium, and Ti6Al4V titanium alloy.

The Comet Anterior Cervical Plate System is intended for anterior fixation. immobilization and stabilization of adjacent cervical vertebral bodies as an adjunct to intervertebral fusion by autogenous and/or allogenic bone graft. The Comet Anterior Cervical Plate System is indicated for anterior cervical fixation (levels C2-C7) for the following indications: degenerative disc disease (defined as neck pain of disogenic 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, kyphosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.

Multi-level anterior cervical plates and fixation screws are being added to the previously cleared single-level Comet Anterior Cervical Plate System. The multi-level device additions consist of duallevel plate lengths ranging from 24mm through 48mm and triple-level plate lengths ranging from 36mm through 72mm. Similarly to the single-level devices, the multi-level devices contain barbed plate fixation pins that are permanently affixed to the plate. Plate fixation screws are used to secure the plate to each vertebrae. An additional plate fixation screw diameter is being added in a 3.3mm diameter in 14mm, 16mm and 18mm lengths.

The Comet Anterior Cervical Plate System is indicated for anterior cervical fixation for the following indications: degenerative disc disease, spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.

The Comet Anterior Cervical Plate System consists of an anterior cervical plate offered in lengths ranging from 10mm through 22mm. Four (4) barbed plate fixation pins are permanently affixed to the plate. A set of two (2) plate fixation screws are used to secure the plate to the superior and inferior vertebrae. Plate fixation screws are offered in two (2) diameters, each in 14mm, 16mm lengths.