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The GII spinal fixation system when used as a pedicle screw system in the non-cervical posterior spine, the GII spinal fixation system is to be used in skeletally mature patients as an adjunct to fusion using autograft and/or allograft for one or more of the following: (1) Degenerative or severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar/first sacral (L5-S1) joint with objective evidence of neurologic impairment, (2) Fracture, (3) Dislocation, (4) Scoliosis, (5) Kyphosis, (6) Spinal tumor, and/or (7) Failed previous fusion (pseudoarthrosis). The GII spinal fixation system when used as a hook and sacral/iliac screw fixation system in the non-cervical posterior spine, the GII spinal fixation system is to be used in skeletally mature patients as an adjunct to fusion using autograft and/or allograft for one or more of the following: (1) Degenerative spondylolisthesis with objective evidence of neurologic impairment, (2) Fracture, (3) Dislocation, (4) Scoliosis, (5) Kyphosis, (7) Spinal tumor, and/or (8) Failed previous fusion (pseudoarthrosis).

The new GII-Ti-Poly-Axial Screw is intended to be used with the existing components, nuts, washers, cross-links and instrumentation as currently provided with the cleared GII Spinal Fixation System. The previously cleared indications for use of the GII Spinal Fixation System are unchanged.

The OstaPek® VBR System are vertebral body (partial or total) replacement devices intended for use in the thoracolumbar spine (T1 - L5) to replace and restore height to a collapsed, damaged, or unstable vertebral body or portion thereof, due to tumor or trauma (fracture or disease). The system is to be used in association with bone graft and supplemental spinal fixation. The supplemental fixation system that is intended is the coLigne, AG, GII Spinal Fixation System.

The implants consist of a system of flattened, cuboid, trapezoida & rectangular shaped implants. The OstaPek® VBR System implants offer substantial variation of size and configuration to better approximate the anatomical variation observed in different vertebral levels and patient anatomy. The devices are manufactured with one or more hollowed out central areas to accommodate bone graft material. The superior and inferior surfaces are manufactured in such a way that a series of lands and grooves are formed in the anterior/posterior direction. The purpose of these lands and grooves is to improve stability and bony fixation once the device is inserted. This device is made from the exact same material as the GII Spinal Fixation System, K051089.

The GII Spinal Fixation System When used as a pedicle screw fixation system in the non-cervical posterior spine in skeletally mature patients, the GII@ Spinal System is indicated for one or more of the following: (1) degenerative spondylolisthesis with objective evidence of neurologic impairment, (2) fracture, (3) dislocation, (4) scoliosis, (5) kyphosis, (6) spinal tumor, and/or (7) failed previous fusion (pseudarthrosis). In addition, when used as a pedicle screw fixation system, the GII@ Spinal System is indicated for skeletally mature patients: (1) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar/first sacral (L5-S 1) joint; (2) who are receiving fusions using autogenous bone graft only; (3) who are having the device fixed or attached to the lumbar and sacral spine (L3 and below); and (4) who are having the device removed after the development of a solid fusion mass. The GII system is also a hook and sacral/iliac screw fixation system of the non-cervical spine indicated for (1) degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), (2) degenerative spondylolisthesis with objective evidence of neurologic impairment, (3) fracture, (4) dislocation, (5) scoliosis, (7) spinal turnor, and/or (8) failed previous fusion (pseudarthrosis).

The new plates are offered in a series of sizes designated by the number of slots or holes within the plates. The I ho w plates are single slot. The new plates are provided precurved to more closely match the natural lordotic curve of the lumbar spine. Two different curves are offered in each size. The devices are produced of a polyner matrix of Polyetherketonekctone (PEKEKK) Resins and long fiber carbon filaments. The new plates are intended to be used with the existing pedicle screws, nuts, washers, cross-links and instrumentation as currently provided with the cleared GII Spinal Fixation System. Because the new material is not a metallic material, precautions against mixing dissimilar metals or of a galvanic/corrosive interaction with the existing implants is eliminated. The previously cleared indications for use are unchanged.

When used as a pedicle screw fixation system in the non-cervical posterior spine in skeletally mature patients, the GII Spinal System is indicated for one or more of the following: (1) degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), (2) degenerative spondylolisthesis with objective evidence of neurologic impairment, (3) fracture, (4) dislocation, (5) scoliosis, (6) kyphosis, (7) spinal tumor, and/or (8) failed previous fusion (pseudarthrosis). In addition, when used as a pedicle screw fixation system, the GII Spinal System is indicated for skeletally mature patients: (1) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral (L5-S 1) joint; (2) who are receiving fusions using autogenous bone graft only; (3) who are having the device fixed or attached to the lumbar and sacral spine (L3 and below); and (4) who are having the device removed after the development of a solid fusion mass. The GII Spinal system is also a hook and sacral/iliac screw fixation system of the non-cervical spine indicated for (1) degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), (2) degenerative spondylolisthesis with objective evidence of neurologic impairment, (3) fracture, (4) dislocation, (5) scoliosis, (6) kyphosis, (7) spinal tumor, and/or (8) failed previous fusion (pseudarthrosis).

The GII Spinal Fixation System implants are intended to be used as temporary construct that assists normal healing and are not intended to replace normal body structures. They are intended to stabilize the spinal operative site during fusion procedures, attaching longitudinal member to the spine by means of spinal anchors. The GII Spinal System is both a rod-based systems and a plate-based system designed on the same pedicular screw foundation. The longitudinal members consist of spinal rods or plates. The spinal anchors consist of pedicular screws. Transverse connectors are also included in the system to provide rigidity to the construct. Optional construct spacers are available to allow better seating of the plates or connectors onto the pedicular screws as well as poliaxiality.