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The Virage Navigation System instruments are to be used during the preparation and placement of Virage® OCT polyaxial screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in open procedures. When used with the Medtronic NavLock arrays, the Virage Navigation instruments can be used with the Medtronic StealthStation ® S7. When used with the ZimVie reference arrays, the Virage Navigation instruments can be used with the Brainlab Navigation System.

The Virage® Navigation System is comprised of nonsterile, reusable instruments including drills, taps, and drivers that can be operated manually and/or under a power surgical technique to prepare for and insert Virage OCT polyaxial screws. The Virage Navigation System instruments are designed for use with either the Medtronic StealthStation S7 or the Brainlab Spine & Trauma Navigation software (version 2.0 and higher). The ZimVie reference arrays can only be used with the Brainlab Spine & Trauma Navigation System. The Virage Navigation System is also compatible with the Zimmer Biomet Universal Power System.

The Vital® Spinal Fixation System implants are non-cervical spinal fixation devices intended for posterior pedicle screw fixation (T1-S2/ilium), posterior hook fixation (T1-L5), or anterolateral fixation (T8-L5). Pedicle screw fixation is indicated for skeletally mature patients and for adolescent patients. These devices are indicated as an adjunct to fusion for all of the following indications: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), deformities or curvatures (i.e. scoliosis, and/or lordosis, Scheuermann's Disease), tumor, stenosis, pseudoarthrosis and/or failed previous fusion. When used as an adjunct to fusion, the Vital Spinal Fixation System is intended to be used with autograft and/or allograft. In addition, the Vital Spinal Fixation System is intended for treatment of severe spondylolisthesis (Grade 3 and 4) of the L5S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft, having implants attached to the lumbosacral spine and or ilium with removal of the implant after attainment of a solid fusion. Levels of pedicle screw fixation for these patients are L3sacrum/ilium. When used for posterior non-cervical pedicle screw fixation in pediatric patients, the Vital System implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The Vital System is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach. The use of the Vital® Spinal Fixation System in skeletally mature patients may include the fixation of the Instinct® Java™ Spinal Fixation System hooks, APEX Spinal System™ hooks, or fixation of the Universal Clamp® Spinal Fixation System to the Vital® Spinal Fixation System. The Vital® Spinal Fixation System may also be used in skeletally immature patients when connected with the Universal Clamp Spinal Fixation System. To achieve additional levels of fixation in skeletally mature patients, the Vital® Spinal Fixation System may be connected to the Virage® OCT Spinal Fixation System and the Instinct Java Spinal Fixation System offered by Zimmer Biomet Spine, using rod connectors.

The Vital® Spinal Fixation System is a thoracolumbar and sacroiliac fixation system designed to aid in the surgical correction of several types of spinal conditions. The system consists of a variety of spinal rods, pedicle screws, hooks and connectors intended only to provide temporary stabilization during the development of a solid fusion of the spine with bone graft. The system can be rigidly locked into a variety of configurations, with each construct being customized to the patient's anatomy. All implants are single use only and should not be reused under any circumstances. The implant system is intended to be removed after solid fusion has occurred. The system also includes instrumentation for insertion, securing and removal of the implants. All implants are made from medical grade titanium alloy; select rods are also available in medical grade cobalt chromium allov. Implants made from medical grade titanium alloy, and medical grade cobalt chromium may be used together. Never use titanium, titanium alloy, and/or cobalt chromium with stainless steel in the same implant construct. Vital® MIS System is a percutaneous screw delivery system that is an extension of the Vital® System. The predicate Vital implants consist of a variety of spinals rods and pedicle screws that are modified under the MIS line extension to feature cannulated screws (extended and nonextended tab) and modified spinal rods (bullet nose, connection, curvature). The system includes a variety of instrumentation which are also compatible with Vital and Vital MIS implant offerings in the Vital® System and allow for a minimalized, percutaneous, or mini-open surgical approach, extending MIS capabilities to the cannulated implants of the wider Vital System.

The Vital Navigation System instruments are used during the preparation and placement of the Vital vy System screws during spinal surgery to precisely locate anatomical structures in either open or minimally invasive procedures. The Vital Navigation System instruments are designed for use with either the Medtronic StealthStation S7 or the Brainlab Spine & Trauma Navigation software. The ZimVie reference arrays can only be used with the Brainlab Spine & Trauma Navigation System.

The Vital™ Navigation System is comprised of nonsterile, reusable instruments including awls, probes, taps, and drivers that can be operated manually. The Vital Navigation System instruments are designed for use with either the Medtronic StealthStation S7 or the Brainlab Spine & Trauma Navigation software. The ZimVie reference arrays can only be used with the Brainlab Spine & Trauma Navigation System. Both combinations are used to assist surgeons in precisely locating anatomical structures in either open or minimally invasive procedures for preparation and placement of Vital and Vitality Screws. This surgical imaging technology provides surgeons visualization for complex and MIS procedures and confirms the accuracy of advanced surgical procedures. The use of these navigation systems provides the surgeon access to real-time multi-plane 3D images) providing confirmation of hardware placement.

The Vital/Vitality Spinal Fixation System implants are non-cervical spinal fixation devices intended for posterior pedicle screw fixation (T1-S2/ilium), posterior hook fixation (T1-L5), or anterolateral fixation (T8-L5). Pedicle screw fixation is indicated for skeletally mature patients and for adolescent patients. These devices are indicated as an adjunct to fusion for all of the following indications: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis, Scheuermann's Disease), tumor, stenosis, pseudoarthrosis and/or failed previous fusion. When used as an adjunct to fusion, the Vital/Vitality Spinal Fixation System is intended to be used with autograft and/or allograft. In addition the VitallVitality Spinal Fixation System is intended for treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft, having implants attached to the lumbosacral spine and or ilium with removal of the implant affer attainment of a solid fusion. Levels of pedicle screw fixation for these patients are L3-sacrum/ilium. When used for posterior non-cervical pedicle screw fixation in pediatric patients, the Vital/Vitality System implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The Vitality System is intended to be used with autograft. Pediatric pedicle screw fixation is limited to a posterior approach. The use of the Vital/Vitality Spinal Fixation System in skeletally mature patients may include the fixation of the Instinct® Java™ Spinal Fixation System* hooks, APEX Spinal System™* hooks, or fixation of the Universal Clamp® Spinal Fixation System* to the Vital/Vitality Spinal Fixation System. The Vital/Vitality Spinal Fixation System may also be used in skeletally immature patients when connected with the Universal Clamp Spinal Fixation System. In order to achieve additional levels of fixation in skeletally mature patients, the Vital/Vitality Spinal Fixation System may be connected to the Virage® OCT Spinal Fixation System* and the Instinct Java Spinal Fixation System offered by Zimmer Biomet Spine, using rod connectors.

The Vital™ Spinal Fixation System is a thoracolumbar and sacroiliac fixation system designed to aid in the surgical correction of several types of spinal conditions. The system consists of a variety of spinal rods, pedicle screws, hooks and connectors intended only to provide temporary stabilization during the development of a solid fusion of the spine with bone graft. The system can be rigidly locked into a variety of configurations, with each construct being customized to the patient's anatomy. All implants are single use only and should not be reused under any circumstances. The implant system is intended to be removed after solid fusion has occurred. The system also includes instrumentation for insertion, securing and removal of the implants are made from medical grade titanium alloy; select rods are also available in medical grade cobalt chromium alloy. Implants made from medical grade titanium, medical grade titanium alloy, and medical grade cobalt chromium may be used together. Never use titanium alloy, and/or cobalt chromium with stainless steel in the same implant construct. The Vital™ Spinal Fixation System is compatible with components from other cleared spinal fixation systems.

Vital Navigation instruments are to be used during the preparation and placement of Vital and Vitality screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. Vital Navigation instruments are specifically 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 a vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks for the anatomy.

The Vital Navigation System is comprised of nonsterile, reusable instruments including awls, probes, taps, and drivers that can be operated manually. These instruments are intended to be used with the Medtronic Synergy™ Experience StealthStation® System to assist surgeons in precisely locating anatomical structures in either open or minimally invasive procedures for preparation and placement of Vital and Vitality screws. This surgical imaging technology provides surgeons visualization for complex and MIS procedures and confirms the accuracy of advanced surgical procedures. Use of these navigation systems provides the surgeon access to real-time, multi-plane 3D images) providing confirmation of hardware placement. Through the introduction of new styluses in this submission, the previously cleared Vital Navigation Taps and Reduction Driver (K191722) can be used with the existing Vital MIS PAT Handle (K203507) to allow the user to navigate while using the PAT or PASIT assembly. It is important to note that these styluses will not be navigated. As such, the toolcard for the NavLock taps or NavLock driver will not change with this new use scenario.

The Virage® Navigation System Instruments are to be used during the preparation and placement of Virage® OCT polyaxial screws during spinal surgery to assist the surgeon in precisely locating anatomical structures. The Virage® Navigation System Instruments are specifically 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 a vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks for the anatomy. The Virage® Navigation Instruments are also compatible with the Zimmer Biomet Universal Power System and the WalterLorenz® Surgical Assist Arm.

The Virage Navigation System is comprised of non-sterile, reusable instruments including drills, taps, and drivers that can be operated manually and/or under a power surgical technique to prepare for and insert Virage OCT polyaxial screws. These instruments are intended to be used with the Medtronic StealthStation® System to assist surgeons in precisely locating anatomical structures. This surgical imaging technology provides surgeons visualization for complex and MIS procedures and confirms the accuracy of advanced surgical procedures. Use of these navigation systems allows the surgeon access to real-time, multi-plane 3D images) thereby providing confirmation of hardware placement.

The Polaris Spinal System is a non-cervical spinal fixation device intended for immobilization and stabilization as an adjunct to fusion as a pedicle screw fixation system, a posterior hook and sacral/iliac screw fixation system, or as an anterior or anterolateral fixation system for use with autograft and/or allograft. The Polaris Spinal System is indicated for the following conditions: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma, (i.e., fracture or dislocation), deformity or curvature (i.e., scoliosis, kyphosis, Scheuermann's disease, and/or lordosis,), tumor, stenosis, pseudoarthrosis, or failed previous fusion. The Ballista and Cypher MIS instruments are intended to be used with Ballista/ Cypher MIS /Polaris 5.5mm implants. Cannulated screws and percutaneous rods may be used with the Ballista/ Cypher MIS instruments to provide the surgeon with a percutaneous approach for posterior spinal surgery for the above indications. For pediatric patients, the Polaris Spinal System may be used for posterior, non-cervical pedicle screw fixation as an adjunct to fusion to treat adolescent idiopathic scoliosis and is also indicated for treatment of the following conditions: spondylolysis and fractures caused by tumor and/or trauma. Pedicle screw fixation is limited to a posterior approach. The Polaris Spinal System may be used with the instruments in the AccuVision Minimally Invasive Spinal Exposure System to provide the surgeon with a minimally invasive approach for posterior spinal surgery. The dominos in the Polaris Spinal System can be used to connect the Polaris Spinal System to the Altius Spinal System, Lineum OCT Spine System, the Array Spinal System, the Biomet Omega21 Spinal System, or the Synergy Spinal System to achieve additional levels of fixation. Please refer to the individual system's Package Insert for a list of the indications for use for each system.

The Polaris Spinal System is a non-cervical spinal fixation device made from titanium alloy (Ti-6Al-4V) per ASTM F136, unalloyed titanium per ASTM F67, stainless steel per ASTM F138 or ASTM F1314 and Cobalt Chrome Alloy (Co-28Cr-6Mo) per ASTM F1537. The system includes screws, various types and sizes of rods, locking nuts, hooks, lateral connectors, plugs, fixation washers, rod connectors/dominos, various cross connectors and accessories. This submission is to update a contraindication related to the translation screws.

The Vitality® Spinal Fixation System implants are non-cervical spinal fixation devices intended for posterior pedicle screw fixation (T1-S2/ilium), posterior hook fixation (T1-L5), or anterolateral fixation (T8-L5). Pedicle screw fixation is indicated for skeletally mature patients and for adolescent patients. These devices are indicated as an adjunct to fusion for all of the following indications: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic sites), spondylolisthesis, trauma (i.e., fracture or dislocation), deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis, Scheuermann's Disease), tumor, stenosis, pseudoarthrosis and/or failed previous fusion. When used as an adjunct to fusion, the Vitality® Spinal Fixation System is intended to be used with autograft and/or allograft. In addition the Vitality® Spinal Fixation System is intended for treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft, having implants attached to the lumbosacral spine and or ilium with removal of the implant after attainment of a solid fusion. Levels of pedicle screw fixation for these patients are L3sacrum/ilium. When used for posterior non-cervical pedicle screw fixation in pediatric patients, the Vitality® System implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The Vitality® System is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach. The use of the vitality Spinal Fixation System in skeletally mature patients may include the fixation of the Instinct® Java™ System hooks, APEX® System hooks, or fixation of the Universal Clamp® Spinal Fixation System to the Vitality Spinal Fixation System. The Vitality Spinal Fixation System may also be used in skeletally immature patients when connected with the Universal Clamp Spinal Fixation System. In order to achieve additional levels of fixation in skeletally mature patients, the Vitality Spinal Fixation System may be connected to the Virage® OCT Spinal Fixation System* and the Instinct Java Spinal Fixation System offered by Zimmer Biomet Spine, using rod connectors.

The Vitality® Spinal Fixation System is a thoracolumbar and sacroiliac fixation system designed to aid in the surgical correction of several types of spinal conditions. The system consists of a variety of spinal rods, pedicle screws, hooks, and connectors intended only to provide temporary stabilization during the development of a solid fusion of the spine with bone graft. The system can be rigidly locked into a variety of configurations, with each construct being customized to the patient's anatomy during surgery. All implants are single use only and should not be reused under any circumstances. The implant system is intended to be removed after solid fusion has occurred. The system also includes instrumentation for insertion and securing of the implants. All implants are made from medical grade titanium alloy; select rods are also available in medical grade cobalt chromium alloy. Implants made from medical grade titanium, medical grade titanium alloy, and medical grade cobalt chromium may be used together. Never use titanium, titanium alloy, and/or cobalt chromium with stainless steel in the same implant construct. The Vitality Spinal Fixation System is compatible with the Virage® OCT Spinal Fixation System Rods, Instinct® Java" Spinal Fixation System Rods and Universal Clamp® Spinal Fixation System.

The Epic Anterior Thoracolumbar Plate System is intended to provide fixation of the thoracic. Jumbar, and/or sacral spine (T1-S1) as an adjunct to fusion using autograft or allograft in skeletally mature patients in the following instabilities or deformities: * Degenerative Disc Disease (DDD, defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); - * Spinal Stenosis (indicated for L1-S1 only); - * Spondylolisthesis; - * Deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis); - * Trauma (i.e., fracture, dislocation, or subluxation); - * Spondylolysis; - * Tumor; - * Pseudoarthrosis: and/or - * Failed previous fusion The Epic Anterior Thoracolumbar Plate System is indicated for use via the lateral or anterolateral surgical approach for fixation of the thoracic and thoracolumbar spine, or via the anterior surgical approach for fixation of the lumbosacral spine below the bifurcation of the great vessels. The Gallery Laminoplasty Fixation System is intended for use in the lower cervical and upper thoracic spine (C3-T3) after a laninoplasty has been performed. The Gallery Laminoplasty Fixation System holds or buttresses the allograft in place in order to prevent the allograft from expulsion or impinging on the spinal cord. The Concero Facet Screw System is intended to stabilize the spine as an aid to fusion through bilateral immobilization of the facet joints, with or without bone graft, at single or multiple levels, from C2 to S1 for 3.5mm and 4.0mm screws and from L1 to S1 for 4.5mm screws. For transfacet fixation, the screws are inserted posteriorly through the superior side of the facet, across the facet joint, and into the pedicle. For translaminar facet fixation, the screws are inserted posteriorly through the lateral aspect of the spinous process, through the superior side of the facet, across the facet joint, and into the pedicle. The Concero Facet Screw System is indicated for treatment of any or all of the following: - * Pseudoarthrosis and failed previous fusions; - * Spondylolisthesis; - * Spondylolysis; * Degenerative Disc Disease (DDD) as defined by neck and/or back pain of discogenic origin as confirmed by radiographic studies; - * Degeneration of the facets with instability and; - * Trauma including spinal fractures and/or dislocations. The Zimmer Biomet Spinal Fixation System is intended to be used to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar, and/or sacral spine. The system is intended for use with autograft or allograft. The Zimmer Biomet Spine Spinal Fixation System is intended for posterior, non-cervical (T1-S2/illum) pedicle and nonpedicle spinal fixation, to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following instabilities or deformities: 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; deformities or curvatures (i.e., scolosis, kyphosis and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion. The Alpine XC Adjustable MIS Fusion System is a posterior, non-pedicle supplemental fixation device, intended for use at a single level in the non-cervical spine (T1-S1). It is intended for plate fixation/attachment to spinous processes for the purpose of achieving supplemental fusion in the following conditions: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); trauma (i.e., fracture or dislocation); and/or tumor. The Alpine XC Adjustable MIS Fusion System is intended for use with bone graft material, not intended for stand-alone use. The Aspen device is a posterior, non-pedicle supplemental fixation device, intended for use at a single level in the noncervical spine (T1-S1). It is intended for plate fixation/attachment to spinous processes for the purpose of achieving supplemental fusion in the following conditions: 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); and/or tumor. The Aspendevice is intended for use with bone graft material, not intended for stand-alone use. The LPlate device is a posterior, non-pedicle supplemental fixation device, intended for use at a single level in the noncervical spine (T1-S1). It is intended for plate fixation/attachment to spinous processes for the purpose of achieving supplemental fusion in the following conditions: 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); and/or tumor. The LPlate device is intended for use with bone graft material, not intended for stand-alone use.

The Zimmer Biomet Spine Miscellaneous Spinal Fixation Systems referred to in this submission include the following systems: Epic, Gallery, Concero, Alpine XC, Aspen and L-Plate. These subject Miscellaneous Spinal Fixation Systems are identical to the predicate Miscellaneous Spinal Fixation Systems, Epic, Gallery, Concero, Alpine XC, Aspen and L-Plate, currently marketed. As defined within the product-specific Indications for Use, the subject Miscellaneous Spinal Fixation Systems are intended for the stabilization and immobilization of spinal segments as an adjunct to fusion in the cervical, thoracic, lumbar and/or sacral spine.

Vital Navigation instruments are to be used during the preparation and placement of Vital and Vitality screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. Vital Navigation instruments are specifically 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 a vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks for the anatomy.

The Vital Navigation System is comprised of nonsterile, reusable instruments including awls, probes, taps, and drivers that can be operated manually. These instruments are intended to be used with the Medtronic Synergy™ Experience StealthStation® System to assist surgeons in precisely locating anatomical structures in either open or minimally invasive procedures for preparation and placement of Vital and Vitality screws. This surgical imaging technology provides surgeons visualization for complex and MIS procedures and confirms the accuracy of advanced surgical procedures. Use of these navigation systems provides the surgeon access to real-time, multi-plane 3D images (and 2D images) providing confirmation of hardware placement.