Search Results

The Opticage® Expandable Interbody Fusion Device is a posterior lumbar intervertebral body fusion device and is indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). The Opticage Interbody Fusion Device can be implanted via posterior, transforaminal or lateral approach. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. Candidates for surgery should be skeletally mature and have had six months of conservative treatment. These patients may have had primary or secondary surgery, but no previous fusion at the involved levels. The device is not intended to be used as a stand-alone device. It must be used with supplemental internal spinal fixation systems that have been cleared for use in the lumbar spine (i.e. facet screw fixation systems, facet compression devices and posterior pedicle screw and rod systems).

The Opticage Expandable Interbody Fusion Devices are provided gamma sterilized and are for single use only. The devices are designed for lumbar intervertebral body fusion via posterior, transforaminal or lateral approach. They are fabricated from titanium alloy (Ti-6AI-4V) as per ASTM F136. Each device consists of five components: an upper and lower titanium plate, two titanium wedges and a central shaft. The faces of the upper and lower plates of the devices contain teeth and fenestrations to enhance bony in growth. The two titanium wedges are connected by the central shaft. The shaft can be rotated clockwise to move the wedges toward the center of the device thereby increasing the distance (i.e. height) between the upper and lower titanium plates. Alternatively, the shaft can be rotated counter clockwise to move the wedges away from the center of the device causing the distance (i.e. height) between the upper and lower plates to decrease. In this manner, the height of the construct can be continuously adjusted through a range of 5mm. A cavity internal to each device is intended to hold autogenous bone graft. The Opticage is available in a variety of configurations.

The Opticage® Interbody Fusion Device is a posterior lumbar intervertebral body fusion device and is indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. These DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). The Opticage Interbody Fusion Device can be implanted via posterior, transforaminal or lateral approach. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radios. Candidates for surgery should be skeletally mature and have had six months of conservative treatments. may have had primary or secondary surgery, but no previous fusion at the involved levels. The device is not intended to be used as a stand-alone device. It must be used with supplemental internal spinal fixation systems that have been cleared for use in the lumbar spine (i.e. facet screw fixation systems, facet compression devices and posterior pedicle screw and rod systems).

Not Found

The Opticage™ Expandable Interbody Fusion Device is a lumbar intervertebral body fusion device and is indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). The Opticage Expandable Interbody Fusion Device can be implanted via posterior, transforaminal, or lateral approach. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. Candidates for surgery should be skeletally mature and have had a six month course of conservative treatment. These patients may have had primary or secondary surgery, but no previous fusion at the involved levels. The device is not intended to be used as a stand-alone device. It must be used with supplemental internal spinal fixation systems that have been cleared for use in the lumbar spine (i.e. facet screw fixation systems, facet compression devices and posterior pedicle screw and rod systems).

The Opticage™ Expandable Interbody Fusion Devices, Model Series 9070 are designed for lumbar intervertebral body fusion via posterior, transforaminal or lateral approach. The devices are fabricated from titanium alloy (Ti-6AI-4V) as per ASTM Fl36. Each device consists of an upper and lower titanium plate, two titanium wedges and a central shaft. The two titanium wedges are connected by the central shaft. The shaft can be rotated to move the wedges toward the center of the device thereby increasing the distance (i.e. height) between the upper and lower titanium plates. Alternatively, the shaft can be rotated in the opposite direction to move the wedges away from the center of the device causing the distance (i.e. height) between the upper and lower plates to decrease. In this manner, the height of the construct can be continuously adjusted. The devices are available in a several footprint sizes. The top and bottom of the devices are fenestrated and each contain windows to enhance bony in growth. A cavity internal to each device is intended to hold autogenous bone graft. The Opticage Expandable Interbody Fusion Devices in Model Series 9070 are provided in both sterile and non-sterile versions.

The Opticage Interbody Fusion Device is a posterior lumbar intervertebral body fusion device and is indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). The Opticage Interbody Fusion Device can be implanted via posterior or transforaminal approach. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. Candidates for surgery should be skeletally mature and have had six months of conservative treatment. These patients may have had primary or secondary surgery, but no previous fusion at the involved levels. The device is not intended to be used as a stand-alone device. It must be used with supplemental internal spinal fixation systems that have been cleared for use in the lumbar spine (i.e. facet screw fixation systems, facet compression devices and posterior pedicle screw and rod systems).

The Opticage™ Expandable Interbody Fusion Device, Model Series 9070 is composed of lumbar intervertebral body fusion implants manufactured from implant grade titanium alloy and ranging in widths from 9 mm x 12 mm and lengths from 21 x 30 mm. Each implant consists of an upper and lower titanium plate and two titanium wedges that interact to change the height of the construct from a minimum of 9 mm to a maximum of 14 mm. The top and bottom plates are fenestrated and contain a window to enhance bony in-growth. A cavity internal to the device is intended to hold autogenous bone graft.

The Opticage Interbody Fusion Device is a posterior lumbar intervertebral body fusion device and is indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). The Opticage Interbody Fusion Device can be implanted via posterior or transforaminal approach. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. Candidates for surgery should be skeletally mature and have had a six month course of conservative treatment. These patients may have had primary or secondary surgery, but no previous fusion at the involved levels. The device is not intended to be used as a stand-alone device. It must be used with supplemental internal spinal fixation systems that have been cleared for use in the lumbar spine (i.e. facet screw fixation systems, facet compression devices and posterior pedicle screw and rod systems).

The Opticage Interbody Fusion Device is a lumbar intervertebral body fusion device manufactured from implant grade titanium alloy. The Opticage Interbody Fusion Device consists of an upper and lower titanium plate and two titanium wedges that interact to change the height of the device. The device is available in a single configuration that ranges in length from 29mm (closed) to 21mm (expanded) and ranges in nominal height from 9mm (closed) to 14mm (expanded). The top and bottom of the device are fenestrated and contain openings to enhance bony in growth. The Opticage Interbody Fusion Device is provided non-sterile, for single use only.

The PERPOS™ FCD-2 System isindicated for spondylolisthesis, spondylolysis, degenerative disc disease (DDD) as defined by back pain of discogenic origin as confirmed by rediographic studies, degeneration of the facets with instability and fracture, pseudoarthrosis, or failed previous fusion. The intended use of the PERPOS™ FCD-2 Anchor and Stabilizer is to stabilize the spine as an aid to fusion through bilateral immobilization of the facet joints. The PERPOS™ FCD-2 may be used to supplement legally marketed anterior fusion products in order to create an anterior/posterior fixation construction as an aid to fusion. The PERPOS FCD-2 is indicated for bilateral facet fixation, with or without bone graft, at single or multiple levels from L1-S1. The intended use of the associated manual surgical instruments is to aid in the implantation of the PERPOS™ FCD-2 Anchor and Stabilizer.

The PERPOS™ FCD-2 Single Use System consists of two each of a double-helix facet screw with a compression-locking collar, retaining ring and a self-retaining polymer washer packaged in a single use tray with the associated manual instruments. Modifications from the predicate device include changes to the washer configuration, instrumentation and packaging.

The 4.5mm BONE-LOK® PLS IMPLANT is indicated for spondylolisthesis, spondylolysis, degenerative disc disease (DDD) as defined by back pain of discogenic origin as confirmed by radiographic studies, degeneration of the facets with instability and fracture, pseudoarthrosis, or failed previous fusion. The intended use of the 4.5mm BONE-LOK® PLS Implant is to stabilize the spine as an aid to fusion through bilateral immobilization of the facet joints. The 4.5mm BONE-LOK® PLS Implant may be used to supplement legally marketed anterior fusion products in order to create an anterior/posterior fixation construction as an aid to fusion. The screws are inserted posteriorly through the superior side of the facet, across the facet joint and into the pedicle. The 4.5mm BONE-LOK® PLS Implant is intended for lumbar bilateral facet fixation, with or without bone graft, at single or multiple levels from L1 to S1. The intended use of the associated manual surgical instruments is to aid in the implantation of the 4.5mm BONE-LOK® PLS Implant.

The 4.5mm BONE-LOK® PLS Implant is a double-helix screw with a compressionlocking collar made of medical grade titanium alloy and is provided "STERILE". The Single use PERPOS™ PLS System contains the 4.5mm BONE-LOK® PLS Implant and disposable surgical instruments for use in implanting the device and is provided "STERILE". The re-usable Compression Tool is provided separately in a "NONSTERILE" condition; sterilization is by moist heat (steam autoclave) and is performed on-site.