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The MOSS VRS Spinal System is intended to provide immobilization of spinal segments in sketally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine. The MOSS VRS Spinal System is intended for posterior, non-cervical pedicle fixation for the following indications: - degenerative disc disease (DDD is 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. i., scoliosis, kyphosis and/or lordosis) - tumor - pseudoarthrosis - failed previous fusion When used for posterior non-cervical pedicle screw fixation in pediatric patients, the MOSS VRS System is indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The MOSS VRS System is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

The Biedermann Motech MOSS VRS Spinal System is a comprehensive thoracolumbosacral spinal system that offers posterior clinical solutions and is indicated for the treatment of significant mechanical instability or deformity of the spine which requires fusion with instrumentation. The MOSS VRS System consists of a variety of screws, polyaxial heads, rods, locking caps, connectors, hooks and associated general instruments. The implant components are available in a variety of sizes and can be rigidly locked into a variety of different configurations to suit the individual pathology and anatomical conditions of the patient. The purpose of this submission is to add components like additional polyaxial heads, cannulated screws, fenestrated screws, screws with larger diameters and lengths and hooks and connectors to the MOSS VRS Spinal System (see K181821). The safety and effectiveness of the fenestrated screws has not been established when used in conjunction with bone cement or for use in patients with poor bone quality (e.g., osteoporosis, osteopenia). This device is intended only to be used with saline or radiopaque dye. All implants of the MOSS VRS System are sinqle-use only and the system is provided non sterile.

The MOSS VRS Spinal System is intended to provide immobilization of spinal segments in sketally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities of the thoracic, lumbar and sacral spine. The MOSS VRS Spinal System is intended for posterior, non-cervical pedicle fixation for the following indications: - 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. fractures or dislocations) - Spinal Stenosis - Curvatures (i.e. scoliosis, kyphosis and/ or lordosis) - Tumor - Pseudoarthrosis - Failed previous fusion When used for posterior non-cervical pedicle screw fixation in pediatric patients, the MOSS VRS system is indicated as an adjunct to fusion to treat adolescent idiopathic scolosis. The MOSS VRS system is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

The Biedermann Motech MOSS VRS Spinal System is a comprehensive thoracolumbosacral spinal system that offers posterior clinical solutions. The MOSS VRS System is a universal set of instruments and implants that are indicated for the treatment of significant mechanical instability or deformity of the spine which requires fusion with instrumentation. The MOSS VRS System provides several options for stabilization of the spine. Therefore, the system includes the following implants: - Pedicle Screws Ø4.35-9mm, length 20-100mm - Rods Ø5,5mm and Ø6,0mm, length 30-95mm, 120-600mm - Locking Caps - Polyaxial Reductionheads The implants of the MOSS VRS System are single-use only and the system is provided non sterile.

The TELIX K Interbody System is intervertebral body fusion device in skeletally mature patients with degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies) at one or two contiguous levels of the lumbar spine (L2-S1). Patients should have six months of non-operative treatment prior to surgery. These implants are used to facilitate fusion in the lumbar spine and are placed via a TLIF approach using autogenous bone. These implants are intended for use with Biedermann Motech supplemental internal fixation products.

The TELIX K Interbody System is intended for use as an intercorporal fusion cage in the lumbar region (L2-L5) and sacral region (S1). Therefore, the system includes the following implants: The TELIX K Interbody System is comprised of slightly curved implants in lengths of 28, 32 and 36mm and heights ranging from 7 to 17mm. Devices that are 7mm in thickness are only available with 0-degrees of lordosis and all other implants possess 5-degrees of lordosis. The implants are introduced via a TLIF approach using autogenous bone. The TELIX K Interbody System must only be implanted in combination with supplemental fixation. The implants of the TELIX K Interbody System are single-use only and the system is provided non sterile.

The MOSS 100 Pedicle Screw System is a thoracolumbar pedicle for the following indications of use: - 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. fractures or dislocations) - Spinal Stenosis - Curvatures (i.e. scoliosis, kyphoses and/ or lordosis) - Tumor - Pseudoarthrosis - Failed previous fusion

The Biedermann Motech MOSS 100 Pedicle Screw System is a comprehensive thoracolumbar spinal system that offers posterior clinical solutions. The MOSS 100 System is a universal set of instruments and implants that are indicated for the treatment of significant mechanical instability or deformity of the spine which requires fusion with instrumentation. The MOSS 100 System provides several options for stabilization of the spine. Therefore, the system includes the following implants: - -Pedicle Screws Ø5-8mm, length 25-80mm - -Rods Ø5.5mm, length 30-95mm, 300mm and 480mm - Locking caps - - Polyaxial Heads - The Polyaxial Heads are mounted onto the Pedicle Screws intra-operatively. The implants of the MOSS 100 System are single-use only and the system is provided non sterile.