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The GetSet GoLIF! Lumbar Interbody Fusion (IBF) system is indicated for interbody fusion with autograft and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft in patients with symptomatic Degenerative Disc Disease (DDD) at either one or two contiguous levels in the lumbar spine, from L1-L2 to L5-S1. These DDD patients may also have up to Grade 1 Spondylolisthesis or retrolisthesis at the involved levels. 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 six months of non-operative treatment. These implants may be implanted via an open or a minimally invasive posterior approach. Alternatively, these implants may also be implanted via a transforaminal approach. These devices are intended to be used with supplemental posterior fixation, which has been cleared by the FDA for use in the lumbar spine.

The GoLIF! Lumbar Interbody Fusion System are sterile implantable cages and sterile instruments intended to be inserted into the intervertebral body space of the lumbosacral spine and intended for intervertebral body fusion. The GetSet GoLIF! implants are designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column. The implants are designed for a unilateral posterior transforaminal (TLIF) approach or posterior lumbar interbody fusion (PLIF) approach. It is specially designed for small incision (minimally invasive), resulting in a relatively atraumatic operation for the patient. Implants, used with supplemental fixation and bone graft, provide improved stability, height restoration and lordosis to optimize fusion. Based on anatomical reasons, implants will be offered in lengths of 22mm and 26mm, heights of 8-14mm in 1mm increments, and at a width of 10mm. The implant has a tapered tip to allow distraction upon insertion, and teeth on the superior and inferior surfaces help the implant to resist implant migration. The dome shape allows for 7-18 degree lordosis when placed at a TLIF Oblique or PLIF position whilst maintaining coronal alignment due to the neutral region in the mid-section of the implant when positioned in a lateral position. The openings allow for packing of bone graft. The GoLIF! Lumbar Interbody Fusion System also includes instruments to facilitate implantation of the subject implant devices. Instruments are manufactured from Polyacrylamide (IXEF), Polybutylene terephthalate (PBT), and medical grade stainless steel.

The GetSet Surgical GoPLF! Posterior Lateral Fusion System is intended for posterior, non-cervical fixation in skeletally mature patients as an adjunct to fusion in the treatment of the following: 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; tumor; pseudoarthrosis; and failed previous fusion. The GoPLF! Posterior Lateral Fusion System is for prescription use only and is to be used in an open, posterior approach, and can be used with autograft and/or allograft.

The GetSet Surgical GoPLF! Posterior Lateral Fusion System is offered sterile and consists of implants and instruments. The GoPLF! Posterior Lateral Fusion System Implants consist of a variety of sizes of pedicle screws, and rods designed to provide immobilization and stabilization of spinal segments as an adjunct to fusion in skeletally mature patients. The pedicle screws are intended to be inserted bilaterally into the pedicles of each vertebral segment, connected with the rod, and intended for spinal fusion at the selected level. The system conforms to patient anatomy for placement in the thoracolumbar human spine and for iliosacral fixation. The GoPLF! Posterior Lateral Fusion System is offered with GetSet GoPLF! general and system-specific instruments as accessories. The method of use of the instruments is provided in the Surgical Technique Guide.