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Expandable Lumbar Fusion Cage (Type I , Type II ) are lumbar interbody fusion devices intended for use in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbosacral spine(L2-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). Expandable Lumbar Fusion Cage (Type II) are to be filled with autogenous bone graft material. This device is intended to be used with supplemental fixation, such as the Posterior Spinal Fixation System.

The Expandable Lumbar Fusion Cage system is a kind of fusion device for thoracolumbar and spinal stability. The main indication of this product is spinal fusion for spinal operation. The components of system are made of titanium alloy. The Expandable Lumbar Fusion Cage system is used by trained orthopaedic surgeons and/or neurosurgeons in a standard operating environment. The Expandable Lumbar Fusion Cage system provides a wide range of implants, including different widths, heights, lengths and angles to choose from.

The Sterile Posterior Spinal Fixation System is intended for posterior, non-cervical fixation as an adjunct to fusion for the following indications: degenerative disc disease (defined as back pain of discogenc origin with degeneration of the disc confirmed by history and radiographic studies); Spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis and/or lordosis); tumor; pseudarthrosis; and/or failed previous fusion.

The Sterile Posterior Spinal Fixation System is a single-use system for surgical fixation of the spine. It is made up of pedicle screws, rods, and interconnecting devices. The implanted parts confer stabilization and fusion of two or more spinal segments and are to be removed once their stabilizing function is no longer required. The implantable devices are manufactured from titanium alloy and are provided sterile. The Sterile Posterior Spinal Fixation System includes the following sets: RS8 LEGEND (designed for open surgery) and RS8 LONG (designed for minimally invasive surgery). Each set comprises of different rods, screws, set screws, and accessory parts, including various lengths and diameters of reduction screws. Both sets are designed for internal posterior thoracolumbar fixation of the spine. Surgical instruments are provided with the subject device and predicate device. The subject of this submission is a design change to Posterior Spinal Fixation System(K201737). The Posterior Spinal Fixation System(K201737) is provided non-sterile and the subject device is provided sterile.

The Posterior Spinal Fixation System is intended for posterior, non-cervical fixation as an adjunct to fusion for the following indications: degenerative disc disease (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; curvatures (i.e., scoliosis, kyphosis and/or lordosis); tumor; pseudarthrosis; and/or failed previous fusion.

The Posterior Spinal Fixation System is a single-use system for surgical fixation of the spine. It is made up of pedicle screws, rods, and interconnecting devices. The implanted parts confer stabilization and fusion of two or more spinal segments and are to be removed once their stabilizing function is no longer required. The implantable devices are manufactured from titanium alloy and are provided non-sterile. The Posterior Spinal Fixation System includes the following sets: RS8 LEGEND (designed for open surgery) RS8 LONG (designed for minimally invasive surgery) Each set comprises of different rods, screws, set screws, and accessory parts, including various lengths and diameters of reduction screws. Both sets are designed for internal posterior thoracolumbar fixation of the spine. Patient diagnosis and individual conditions should be taken into consideration when selecting the surgical option.