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The Republic Spine Dark Deformity Pedicle Screw System is intended for posterior, non-cervical pedicle fixation of the spine 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 the thoracic, lumbar, and sacral spine: - 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 - Curvature (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 Dark Star Deformity Pedicle Screw System implants are indicated as an adjunct to treat progressive spinal deformities (i.e., scoliosis, kyphosis, or lordosis) including idiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis. Additionally, the Dark Star Deformity Pedicle Screw System is intended to treat pediatric patients diagnosed with: spondylolisthesis/spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/ or failed previous fusion. This system is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

The Republic Spine Dark Star Deformity Pedicle Screw System (previously cleared as Dark Star Spinal System) is a multi-component posterior spinal fixation system which consists of pedicle screws, set screws, rods, hooks, connectors, and crosslinks. The system contains non-sterile single use components manufactured from titanium alloy (Ti-6Al-4V ELI per ASTM F136) and Cobalt Chromium (CoCr per ASTM F1537). Various sizes of these implants are available. Instrumentation is available for the delivery and removal of the Republic Spine Dark Star Deformity Pedicle Screw System. The system allows the surgeon to build a spinal implant construct to stabilize and promote spinal fusion. The scope of the Republic Spine Dark Star Deformity Pedicle Screw System is being extended with this submission via a line extension to offer new implant options including connectors, prebent rods, crosslinks, and hooks and to offer implant design modifications to the uniplanar screws, to the connectors, and to the hooks. New instrumentation will also be introduced to aid in the implantation of the new and existing implants. The indications for use are being expanded to include pediatric applications.

Dark Star Navigated Instrument System is intended to be used during the preparation and placement of Dark Star screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. These instruments are designed for use with the Medtronic StealthStation® System, which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.

The Republic Spine, LLC Dark Star Navigation Instrument System consists of reusable surgical instruments intended for use with the Medtronic® StealthStation® Navigation System to assist surgeons in precisely locating anatomical structures in open procedures for preparation and placement of pedicle screw system implants. The Dark Star Navigation Instrument System includes taps, awls, probes, and drivers. The Dark Star Navigation Instrument System is to be used with the Dark Star Spinal System. The instruments are made from stainless steel. The Dark Star Navigation Instrument System is not compatible with implants from other manufacturers and is designed for use only with Medtronic StealthStation Navigation System hardware and software.

The Republic Spine Dark Star Spinal System is intended for posterior, non-cervical pedicle fixation of the spine 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 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; • Curvature (i.e. scoliosis, kyphosis, and/or lordosis); • Tumor; • Pseudoarthrosis; and • Failed previous fusion.

The Republic Spine Dark Star Spinal System is a multi-component posterior spinal fixation system which consists of pedicle screws, rods, locking spacers, and cross-linking mechanism. The system contains non-sterile single use titanium alloy (Ti-6Al-4V ELI per ASTM F136) and Cobalt Chromium (CoCr per ASTM F1537). Various sizes of these implants are available. Instrumentation is available for the delivery and removal of the Republic Spine Dark Star Spinal System. The system allows the surgeon to build a spinal implant construct to stabilize and promote spinal fusion. The scope of the Republic Spine Dark Start Spinal System is being extended via a line extension to include additional rods, connectors, hooks and screws. New instrumentation will also be introduced to aid in the implantation of the new implants. The safety and effectiveness of the fenestrated screw have not been established when used in conjunction with bone cement or for use in patients with poor bone quality (e.g., osteoporosis, osteopenia). The fenestrated screws are intended to be used with saline or radiopaque dye.

The Republic Spine Dark Star Spinal System is intended for posterior, non-cervical pedicle fixation of the spine 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 (T1-S1): · Severe Spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra - · Degenerative spondylolisthesis with objective evidence of neurologic impairment - · Trauma (i.e. fracture or dislocation) - · Spinal stenosis - · Curvature (i.e. scoliosis, kyphosis, and/or lordosis) - Tumor - · Pseudoarthrosis (failed previous fusion)

The Republic Spine Dark Star Spinal System is a multi-component posterior spinal fixation system which consists of pedicle screws, rods, locking spacers, and cross-linking mechanism. The system contains non-sterile single use titanium alloy (Ti-6Al-4V ELI) implantable components that comply with ASTM F136. Various sizes of these implants are available. Instrumentation is available for the delivery and removal of the Republic Spine Dark Star Spinal System. The system allows the surgeon to build a spinal implant construct to stabilize and promote spinal fusion.