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The Scient'X Anterior Buttress Plate is intended for use in spinal fusion procedures as a means to maintain the relative position of weak bony tissue such as allografts or autografts. The device is not intended for load bearing indications.

The Anterior Buttress Plate is a graft containment device that features a Ti plate fixed by a vertebral body screw. The Ti plate is connected to a PEEK buttress that extends over the adjacent intervertebral space maintaining the position of the bone graft.

The Scient'x Tribeca™ Cage implants are indicated for use with autogenous bone graft as an intervertebral body fusion device at either one or two contiguous levels in the lumbosacral spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The Tribeca™ Cage is to be used in skeletally mature patients who have had six months of non-operative care. The Tribeca™ Cage is implanted using an anterior or posterior approach and is intended to be used single or in pairs with ISOBAR ø6.2mm Hemispherical Screws with Offset Clamps and ø5.5mm Rods.

The Tribeca™ Cage involves lumbar component spinal interbody fusion devices as well as instrumentation designed specifically for the implantation of these devices. The Tribeca™ Cage is manufactured from PEEK-OPTIMA polymer and is provided nonsterile.

Davantis/Antelys Vertebral Body Replacements are vertebral body replacements for use in the lumbar and thoracic spine (T4-L5) to replace a damaged, collapsed or unstable vertebral body due to tumor or trauma (i.e. fracture). These are not stand-alone devices, ISOBAR 06.2 Hemispherical Screws with Offset Clamps and Ø5.5 Rods must be utilized to enhance the stability of the reconstruction in skeletally mature patients following full or partial corpectomy.

The DAVANTIS/ANTELYS Vertebral Body Replacements are oval shaped. The interior of the spacers has three compartments to provide space for bone graft. The implanted in the vertical position. These components are available in various heights (9mm-75mm). The superior and inferior surfaces of these components have ridges to interface with the vertebral endplates to resist rotation. The body has a multitude of holes to allow additional impaction of bone graft. The DAVANTIS!ANTELYS components are fabricated from pure poly(ether ether ketone) (PEEK). This material closely matches the modulus of elasticity of cortical bone, improving the biomechanical interface and reducing the stress shielding effect. They are fully radio-translucent, which enables optimum follow-up with diagnostic imaging, as the interbody fusion progresses. Two metal wires at the opposite ends of the spacers allow radiological confirmation of the cage position post operatively.

The EASYS Transverse Connection used with the ISOBAR Spinal System is intended for posterior, nonpedicle screw fixation of the noncervical spine/hook and sacral/iliac screw fixation to the noncervical spine/hook and sacral screw fixation to the T1-S1 spine. Indications for use include: - 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 - deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis) - tumor - pseudoarthrosis - failed previous fusion The ISOBAR Spinal System is a pedicle screw system indicated for the treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion. The ISOBAR Spinal System is a pedicle screw system intended to provide 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 thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, spinal tumor, and failed previous fusion (pseudarthrosis).

The ISOBAR Spine System is a pedicle screw system intended to provide immobilization 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 thoracic, lumbar or sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, spinal tumor, and failed previous fusions. As a pedicle screw system the ISOBAR Spinal System is intended for the treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebrae in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion. The ISOBAR Spinal System consists of monoaxial and polyaxial pedicle screws (K990118, K013447 and K020245) rods, nuts and cross link members. It can be used for single or multiple level fixation. It also included single and double hooks (K013444 and K013440) used for posterior, nonpedicle screw fixation of the noncervical spine/hook and sacral/illiac screw fixation to the noncervical spine/hook and sacral screw fixation to the T1-S1 spine. All components are manufactured from titanium alloy (Ti-6AI-4V) that conforms to ASTM F136. The additional component that is the subject of this Special 510(k) submission is the EASYS Transverse Connection. Its purpose is to provide rigidity to the spinal construct similar to the crosslink cleared on K990118. It consists of a cross bar and two self locking jumper consists of a clamp and tightening screw.