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The Biolign® Tlif Interbody Fusion Devices are indicated for use with autograft bone graft in skeletally mature patients with degenerative disc disease (DDD) at one level or two contiguous levels of the lumbar spine (L2 - S1). DDD is defined as backpain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). These patients should be skeletally mature and have six (6) months of non-operative therapy. The Biolign® TLIF Intervertebral fusion devices are used to facilitate fusion in the lumbar spine and are implanted via a postero-lateral approach. The Biolign® intervertebral fusion devices are intended to be used with supplemental fixation systems that have been cleared for use in the lumbosacral spine for example posterior pedicle screw and rod systems. The Biolign® ACIF System is indicated for use as an intervertebral body fusion device in skeletally mature patients with degenerative disc disease at one level from C3-C7. Cervical disc disease is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. Patients should have six (6) weeks of non-operative treatment. The Biolign® ACIF System is to be used with autograft bone graft and is implanted via an open anterior approach. The Biolign® ACIF System is intended to be used with supplemental fixation systems that have been cleared for in the cervical spine, such as Anterior Cervical plating systems. The Biolign® STACC ACIF System is indicated for use as an intervertebral body fusion device in skeletally mature patients with degenerative disc disease at one level from C3-C7. Cervical disc disease is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. Patients should have six (6) weeks of non-operative treatment. The Biolign® STACC ACIF System is to be used with autograft bone graft and is implanted via an open anterior approach. The Biolign STACC ACIF system is intended to be used as a stand-alone system using the bone screws provided for fixation. It may also be used with supplemental fixation system that have been cleared for use in the cervical spine, such as cervical plating systems.

The Biolign TLIF device is a slightly curved cage manufactured from Invibio PEEK Optima LT1 with cavities which can be packed with autograft. The cage has tantalum markers which allow accurate and correct placement of the device. The cage is postero-laterally inserted. The cage incorporates a threaded introducer hole on each end and has serrated inferior and superior endplates. It is available in two footprints (30x13mm, and 36x13mm), two lordotic angles (5° and 10°), and a range of heights ranging from 6 - 12mm with 1mm intervals These sizing options allow selection for individual pathology and anatomical conditions. The device is used with supplemental fixation such as screw and rod systems. The Biolign® TLIF system is provided sterile.. The System is single use only. The Biolign ACIF device is an anatomically correct cage manufactured from Invibio PEEK Optima LT1 with a central cavity which can be packed with autograft. The cage is available in two footprints (15 and 17mm) with a 10° lordotic angle. Cage heights range from 6mm-10mm with 1mm intervals. These sizing options allow selection for individual pathology and anatomical conditions. Tantalum radiographic markers enable clear x-ray control during placement and follow-up. The cage endplates are serrated. The Device is inserted below the anterior surface of the cervical vertebrae. It is used with supplemental cervical plating systems which have prominence from the spine (plate thickness). The Biolign® ACIF system is provided sterile The System is for single use only. The Biolign® STACC ACIF Interbody Fusion Device is a stand-alone device and does not rely on additional fixation such as cervical plates. The device is an anatomically shaped ring, with a central cavity which can be packed with autograft. It is manufactured of Invibio Peek Optima LT1. Two Tantalum pins are placed in the device to enable radiographic visualization for placement and follow-up evaluations. The superior, and inferior endplates of the device are serrated. Two fixation screws per cage are used as supplemental fixation. These screws are placed into the cage and purchase into the vertebral endplates. The fixation screws are manufactured of Titanium 6Al4V ELI. The footprint of the cage is available in one size (17 x 14mm), and in heights ranging from 5.5 - 9.5mm with 1mm intervals. The cage is available in a domed (superior endplate is domed, and inferior endplate has 3° lordosis angle) and a tapered version (8° lordosis - 4° per endplate) The device is implanted using an anterior approach and after implantation does not stand prominent from the cervical spine. It lies below the anterior surface of the cervical spine. The Biolign® STACC ACIF system is supplied sterile. The System is for single use only.

The Vertefix® Pedicle Screw Spinal System is intended for posterior, non cervical pedicle fixation in skeletally mature patients receiving fusion by autogenous bone graft in the thoracolumbar spine for the following indications: Spondylolisthesis, Trauma (e.g.fracture or dislocation), Spinal stenosis, deformities or curvatures (scoliosis, kyphosis or lordosis), tumor, pseudoarthrosis, and failed previous fusion. Removal of the implants after the attainment of a solid fusion is optional.

The Vertefix® Pedicle Screw Spinal System is a multiple component, posterior spinal fixation system which consists of pedicle screws, rods, set screws, connectors, hooks, and a transverse (cross) linking mechanism. The Vertefix® Pedicle Screw Spinal System will allow surgeons to build a spinal implant construct to stabilize and promote spinal fusion. The Vertefix® Pedicle Screw Spinal System components are supplied non-sterile, and are single use.

The Vertefix® Pedicle Screw Spinal System is intended for posterior, non cervical pedicle fixation in skeletally mature patients receiving fusion by autogenous bone graft in the thoracolumbar spine for the following indications: Spondylolisthesis, Trauma (e.g.fracture or dislocation), Spinal stenosis, deformities or curvatures (scollosis, kyphosis or lordosis), tumor, pseudoarthrosis, and failed previous fusion. Removal of the implants after the attainment of a solid fusion is optional.

The Vertefix® Pedicle Screw Spinal System is a multiple component, posterior spinal fixation system which consists of pedicle screws, rods, set screws, connectors, hooks, and a transverse (cross) linking mechanism. The Vertefix® Pedicle Screw Spinal System will allow surgeons to build a spinal implant construct to stabilize and promote spinal fusion. The Vertefix® Pedicle Screw Spinal System components are supplied non-sterile, and are single use.