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The Pantheon Pedicle Screw System is intended to provide immobilization of the spine in skeletally mature patients as an adjunct to fusion for procedures of the thoracic, lumbar, and sacral spine (T1-S1). This system is intended for anterior/anteral non-pedicle fixation, posterior non-pedicle fixation, and posterior pedicle fixation for the following indications: degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, curvatures (i.e., scoliosis, kyphosis), tumor, pseudoarthrosis, and failed previous fusion. The Pantheon Iliac Bolt Fixation System is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.

The Pantheon Pedicle Screw Fixation System is a top loading, multiple component, posterior spinal fixation system which consists of pedicle screws, rods, hooks, and cross links that are used for attachment to the non-cervical spine (the thoracic spine through the sacrum and in the ilium). Implant components are available in a variety of sizes so that constructs may be assembled to suit the individual pathology and anatomy of the patient. Rods span the distance between screws and achieve fixation by the mechanical joining of the rods with screws. The Pantheon Iliac Bolt Fixation System has threaded screw implants with dual helix threads designed to be able to screw into pre-drilled bone in the sacrum. Implant components are available in a variety of sizes so that constructs may be assembled to suit the individual pathology and anatomy of the patient. Optional lag rings are also available. Screws, rods, cross links, and other implant components are made from titanium alloy (Ti-6Al-4V) conforming to ASTM F136 or ISO 5832-3. Additionally, some rods may be manufactured from cobalt-chrome alloy (Co-Cr) conforming to ASTM F1537 or ISO 5832-12.

When used as an intervertebral fusion device, the Pantheon IBFD devices are intended for use as either one level or two contiguous levels in the lumbar spine from L2 to S1, for the treatment of treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The lumbar device is to be used in patients who are skeletally mature and have had six months of non-operative treatment. Patients with previous non-fusion spinal surgery at involved level may be treated with the devices are intended for use with supplemental fixation cleared for use in the lumbar spine and with autograft to facilitate fusion.

The Pantheon IBFD is oval in shape with one or more openings through the structure. Pyramidal teeth are incorporated on the inferior surfaces of each device. Tantalum markers provide visual feedback with respect to the invivo implant position. An articulating hub provides adjustable angulation of the device with respect to the inserter shaft. The devices are available in a variety of sizes to accommodate differing anatomic requirements. The device is manufactured from medical grade PEEK in accordance with ASTM F2026 and Ti6Al4V titanium alloy with tantalum markers conforming to ASTM F136. The subject device introduces the 20 degree hyperlordotic sizes in a variety of lengths, widths and heights.

The Pantheon Spinal Pontus Interbody Fusion Device is indicated for intervertebral body fusion of the spine in skeletally mature patients. Pantheon Spinal Pontus Interiody Fusion Device is designed for use with autogenous bone graft to facilitate fusion. Pantheon Spinal Pontus Interbody Fusion Device is intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The lumbar devices are to be used in patients who have had at least six months of non-operative treatment. Pantheon Spinal Pontus Interbody Fusion Device is intended to be used with supplemental internal spinal fixation systems that are cleared by the FDA for use in the lumbar spine. These implants may be implanted via a variety of open or minimally invasive approaches. These approaches include anterior and lateral.

The Pantheon Spinal Pontus Interbody Fusion Device is rectangular with one or more openings through the structure for placement of bone graft. The Epiphany device is hexahedral in geometry with two vertical openings. Pyramidal teeth are incorporated on the inferior and superior surfaces of each device. Tantalum markers provide visual feedback with respect to the invivo implant position. An articulating hub provides adjustable angulation of the device with respect to the inserter shaft. The devices are available in a variety of sizes offered in widths 18-24mm (2mm increments), in lengths 40-60mm (5mm increments), heights 8-16mm (2 mm increments), in 0. 7 and 12 degree lordosis to accommodate differing anatomic requirements.