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Fortitude Vue is a vertebral body replacement device that is intended for use in the thoracic and/or thoracolumbar spine (T3 - L5) to replace a collapsed, damaged or unstable vertebral body resected or excised (i.e., partial or total vertebrectomy procedures) due to tumor or trauma (i.e., fracture). Fortitude Vue is designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column even in the absence of fusion for a prolonged period. Fortitude Vue is intended to be used with bone graft.

Fortitude Vue is a hollow device intended for use as a spinal intervertebral body fixation orthosis.

To provide a self-locking mechanism to hold the edges of a wound open and allow for surgical exposure during general use and neurosurgical procedures.

The Harmony Port System includes the Harmony Port, which provides surgical exposure during minimally invasive procedures, along with accessory instruments designed to facilitate the use of the Port and rigidly fix the system during use.

The Spinous Process Plate is intended for fixation to adjacent spinous processes (L1-L5) as an adjunct to anterior interbody fusion and bone graft. The indications for the spinous process plate include spinal trauma, degenerative spondylolisthesis and degenerative disc disease. The spinous process plate should only be used in the presence of a vertebral body replacement device such as the Spinal Concepts, Inc. InFix® System.

The Tandem system consists of spinous process plates and interconnecting male and female grommets. The implants are used in combination with a vertebral body replacement device such as the Spinal Concepts, Inc. InFix System. The plates feature a slim profile, several rows of spikes, and holes on each end with a spherical seat for grommet attachment. The spikes around the plate holes resist plate rotation after implantation, while a row of spikes over the intraspinous ligament aids in fixation to any optional bone graft.

Coda is a vertebral body replacement device intended for use in the thoracic and/or thoracolumbar spine (T3 - L5) to replace a collapsed, damaged or unstable vertebral body resected or excised (i.e., partial or total vertebrectomy procedures) due to tumor or trauma (i.e., fracture). Coda is designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column even in the absence of fusion for a prolonged period. Coda is intended to be used with bone graft and supplemental fixation. Additionally, Coda is intended to be implanted in a paired configuration.

Coda is manufactured from implantable grade titanium 6AL-4V alloy that conforms to ASTM F-136. The device consists of two opposing surfaces that make contact with the bony endplates of the vertebral bodies, and can be adjusted to provide from 0-11 degrees of fordosis. Coda is available in two lengths and widths, and in various heights to provide the surgeon anatomic flexibility. Coda is a vertebral body replacement device that is intended for use in the thoracic and/or thoracolumbar spine (T3 - L5) to replace a collapsed, damaged or unstable vertebral body resected or excised (i.e., partial or total vertebrectomy procedures) due to tumor or trauma (i.e., fracture).

Cadence and TraXis are vertebral body replacement devices that are intended for use in the thoracic and/or thoracolumbar spine (T3 - L5) to replace a collapsed, damaged or unstable vertebral body resected or excised (i.e., partial or total vertebrectomy procedures) due to tumor or trauma (i.e., fracture). These devices are designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column even in the absence of fusion for a prolonged period. These devices are intended to be used with bone graft.

Cadence™ is a hollow device with texture on two opposing flat sides. The device is crafted from titanium alloy (ASTM F136) or PEEK OPTIMATM (polvaryletheretherketone, ASTM F2026) and is offered in a tapered style of various sizes. TraXisTM is a hollow device with texture on two opposing flat sides. The device is crafted from titanium alloy (ASTM F136) or PEEK OPTIMATM (polyaryletheretherketone, ASTM F2026) and is offered in various lengths, widths and heights.

When intended for pedicle screw fixation from L1-S1, the indications include 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 lumbar and sacral spine: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), tumor, and failed previous fusion. As a pedicle screw system placed between L3 and S1, the indications include Grade 3 or Grade 4 spondylolisthesis, when utilizing autologous bone graft, when affixed to the posterior lumbosacral spine, and intended to be removed after solid fusion is established. After solid fusion occurs, these devices serve no functional purpose and should be removed. In most cases, removal is indicated because the implants are not intended to transfer or support forces developed during normal activities. Any decision to remove the device must be made by the physician and the patient, taking into consideration the patient's general medical condition and the potential risk to the patient of a second surgical procedure.

InSight constructs consist of bone screws, lock screws, connectors, swivels, and rods, which when assembled create a polyaxial range of motion. InSight only allows the placement of 5.5 mm titanium rods. InSight screws may be implanted in an open manner; or via cannulation, which allows a subset of procedures to be completed through a mini open procedure.

When intended to promote fusion of the cervical spine and the thoracic spine, (C1-T3), the NexLink Spinal Fixation System is indicated for the following: DDD (neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, spinal stenosis, fracture, dislocation, failed previous fusion and/or tumors. Hooks and rods are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C1-T3) spine. The use of multiaxial screws is limited to placement in T1-T3 in treating thoracic conditions only. The multiaxial screws are not intended to be placed in the cervical spine.

The Spinal Concepts, Inc. Nex-Link Spinal Fixation System consists of a series of longitudinal members, anchors, and transverse connectors. The Nex-Link system is intended for fixation to, and stabilization of, the cervicothoracic spine. Nex-Link implants are manufactured from medical grade Ti-6A1-4V ELI titanium alloy per ASTM F-136 or commercially pure titanium per ASTM-F-67.

The TraXis Cement Restrictor System is intended for use as a cement restrictor in orthopedic surgeries such as those involving the femoral canal and tibial plateau in hip stem and total knee replacement. This device is not intended for any spinal indications. The safety and effectiveness of this device when implanted in the spine have not been established.

The Spinal Concepts Inc. TraXis Cement Restrictor is a modified version of the Spinal Concepts Cadence Cement Restrictor (K022218 and K023647). Both are indicated for use as cement restrictors in orthopedic surgeries such as those involving the femoral canal and tibial plateau in hip stem and total knee replacement. TraXis is crafted from titanium alloy (ASTM F136) or PEEK OPTIMA™ (polyaryletheretherketone, ASTM F2026). As PEEK OPTIMA™ is radiolucent, radiographic markers are included in the distal and proximal ends of the PEEK implants. The markers consist of tantalum wires (ASTM F560) that are press-fit into small holes in the implant. TraXis is offered in various lengths, widths and heights. TraXis is intended for restriction of bone cement in the distal femoral canal.

The InFix System is a vertebral body replacement device intended for use in the thoracic and/or thoracolumbar spine (T3 - L5) to replace a collapsed, damaged or unstable vertebral body resected or excised (i.e., partial or total vertebrectomy procedures) due to tumor or trauma (i.e., fracture). InFix is designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column even in the absence of fusion for a prolonged period. The InFix is intended to be used with bone graft.

InFix® is manufactured from implantable grade titanium 6AL-4V alloy that conforms to ASTM F-136, and is available in various sizes and dimensions. The device is comprised of two opposing endplates supported by vertical members or "struts" that can be varied in height such that the surgeon can fix the vertebrae in a proper anatomical alignment and lordosis. Each of the struts includes a load-sharing mechanism that allows a limited amount of strain across the fusion mass while supporting the load bearing surfaces. An Ultra High Molecular Weight Polyethylene (UHMWPE) end cap may be placed inside the device prior to packing of bone graft to effectively block the posterior opening in the device and contain the material inside. Holes in the titanium endplates provide space for bone in-growth while angled spikes (teeth) penetrate the vertebral endplates and provide resistance to rotation and migration.

The Fortitude Cement Restrictor System is intended for use as a cement restrictor in orthopedic surgeries such as those involving the femoral canal and tibial plateau in hip stem and total knee replacement. This device is not intended for any spinal indications. The safety and effectiveness of this device when implanted in the spine have not been established.

Fortitude, cleared as a cement restrictor via K021719, is currently crafted from titanium alloy (ASTM F136). The purpose of this special 510(k) is to obtain clearance to market a PEEK OPTIMA™ (polyaryletheretherketone, ASTM F2026) version of Fortitude. The modification does not change the intended use or the fundamental scientific technology of the device. As PEEK OPTIMA™ is radiolucent, radiographic markers are included in the distal and proximal ends of the PEEK implants. The markers consist of tantalum wires (ASTM F560) that are press fit into small holes in the implant. Fortitude is a hollow device with texture on two opposing flat sides, and is offered in straight and tapered styles of various sizes. Fortitude is intended for restriction of bone cement in the distal femoral canal (see figure below).