Search Results

The Vertiwedge® Intraosseous System is indicated for use in the thoracolumbar spine (TI-L5) for partial replacement of a diseased or damaged vertebral body resected or excised to replace a portion and/or restore the height of a collapsed vertebral body for the treatment of previous trauma (i.e. fracture or tumor) or degenerative spine disease. The system is to be placed within the vertebral body following an osteotomy and supplemented with autograft or allograft and to be used with its contralateral staple; should a physician choose to use fewer than the maximum number of screws, then supplemental fixation must be used to augment stability. The Vertiwedge® Intraosseous System is intended to restore the integrity of the spinal column even in the absence of fusion in patients with advanced stage turnors involving the thoracolumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion.

Vertiwedge® Intraosseous System is an intraosseous device that is used as a motion-preservation partial vertebral replacement device in the thoracolumbar spine in the motion-sparing Vertebral Body Osteotomy (VBO®) procedure. The Vertiwedge® Intraosseous device is used within a single osteotomized vertebral body, and it does not span any disc levels nor involve resection of or interference with the discs. The Vertiwedge® Intraosseous device is implanted through an anterior to psoas/oblique approach following an osteotomy of the vertebral body, in a Vertebral Body Osteotomy (VBO®) procedure The Vertiwedge® Intraosseous System consists of the intraosseous wedge (or spacer) with a lateral plate and a unique staple that provides integrated contralateral fixation. The Vertiwedge® Intraosseous System is available in a variety of heights and geometric options to accommodate variations in pathology and patient anatomy. Protrusions on the superior and inferior surfaces grip the osteotomized vedges to aid in expulsion resistance. The Vertiwedge® Intraosseous System is to be filled with autogenous bone graft and/or allogeneic bone graft material, and is to be used with the titanium alloy bone screws and cover plate to provide fixation within the single impacted vertebral body. All implant components are manufactured from Ti-6Al-4V ELI per ASTM F3001 or ASTM F136.

The Interwedge® Standalone Lateral is a standalone lateral lumbar interbody fusion device intended for use in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbosacral spine (L1-S1). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. In addition, these patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). The Interwedge® Standalone Lateral is to be filled with autogenous bone graft and/or allogeneic bone graft composed of cancellous, cortical, and/or corticocancellous bone, and is to be used with the two titanium alloy screws which accompany the implant. Should a physician choose to use fewer than these two screws, additional supplemental fixation must be used to augment stability.

The Interwedge® is a lateral standalone intervertebral body fusion device in the lumbosacral spine (L1-S1) intended to provide stability and promote fusion between adjacent vertebrae. The Interwedge® consists of the intravertebral wedge (or spacer) with a lateral plate and a contralateral staple. The lateral plate, with two or four bones screw options, and the contralateral staple provide the integrated fixation to the construct. The Interwedge device is offered in a range of implant sizes and heights to cater to different patient anatomy. The spacer, lateral plate, and staple components will be additively manufactured from Ti-6A1-4 ELI per ASTM F3001. The sub-components of the staple mechanism and the integrated fixation screws will be machined from Ti-6Al-4V ELI per ASTM F136. A cover plate which is attached to the lateral plate after insertion of the bone screws is manufactured from Ti-6Al-4V ELI per ASTM F136.