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ExcelsiusGPS® is intended for use as an aid for precisely locating anatomical structures and for the spatial positioning and orientation of an instrument holder or guide to be used by surgeons for navigating and/or guiding compatible surgical instruments in open or percutaneous provided that the required fiducial markers and rigid patient anatomy can be identified on CT scans or fluoroscopy. The system is indicated for the placement of spinal and orthopedic bone screws. ExcelsiusHub™ is intended for use as an aid for precisely locating anatomical structures to be used by surgeons for navigating compatible surgical instruments in open or percutaneous procedures provided that the required fiducial markers and rigid patient anatomy can be identified on CT scans or fluoroscopy. The system is indicated for the placement of spinal and orthopedic bone screws.

Subject ExcelsiusGPS® instruments consist of array sleeve adapters and surgical instruments, including drivers, drills, taps, and probes, that may be used manually or navigated with the use of ExcelsiusGPS® or ExcelsiusHub™. The surgical instruments are used to prepare the implant site or implant the device. Instruments are non-sterile and reusable.

The COSINE™ Spacer is an interbody fusion device intended for use at one or more levels of the thoracic spine (T1-T12), thoracolumbar junction (T12-L1), or lumbosacral spine (L1-S1) as an adjunct to fusion in patients with the following indications: degenerative disc disease (DDD), disc herniation (with myelopathy and/or radiculopathy), spondylolisthesis, deformity (degenerative scoliosis or kyphosis), spinal stenosis, and failed previous fusion (pseudarthrosis). 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. The COSINE™ Spacer is to be filled with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone or a bone void filler as cleared by the FDA for use in intervertebral body fusion to facilitate fusion. This device is intended to be used with supplemental fixation systems that have been cleared for use in the thoracolumbosacral spine (e.g., posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems). Hyperlordotic interbody devices (≥20° lordosis) must be used with at least anterior supplemental fixation.

COSINE™ Spacers are expandable lateral lumbar interbody fusion devices used to provide structural stability in skeletally mature individuals following discectomy. The devices are available in various heights and geometric options to fit the anatomical needs of a wide variety of patients. COSINE™ Spacers are manufactured from titanium alloy per ASTM F136 or ASTM F1295. The endplates are additively manufactured from titanium powder, as specified in ASTM F3001, and an internal component is manufactured from radiolucent PEEK polymer.

The DuraPro™ Oscillating System is indicated for drilling, burring, removing, and otherwise manipulating hard and soft tissue, bone, and other bone related tissue during spinal and orthopedic procedures. ExcelsiusGPS® is intended for use as an aid for precisely locating anatomical structures and for the spatial positioning and orientation of an instrument holder or guide tube to be used by surgeons for navigating and/or guiding compatible surgical instruments in open or percutaneous procedures provided that the required fiducial markers and rigid patient anatomy can be identified on CT scans or fluoroscopy. The system is indicated for the placement of spinal and orthopedic bone screws and interbody fusion devices. ExcelsiusHub™ is intended for use as an aid for precisely locating anatomical structures to be used by surgeons for navigating compatible surgical instruments in open or percutaneous procedures provided that the required fiducial markers and rigid patient anatomy can be identified on CT scans or fluoroscopy. The system is indicated for the placement of spinal and orthopedic bone screws and interbody fusion devices.

DuraPro™ Oscillating System consists of electrical The drill handpieces/attachments powered by an oscillating motor with a foot switch, and may be navigated using ExcelsiusGPS® or ExcelsiusHub™. The navigated components are provided non-sterile and are reusable. Attachments are provided sterile and are single-use.

VERZA™ High Speed Drills are indicated for drilling, burring, removing, and otherwise manipulating hard tissue, bone, bone cement, prosthesis, implant, and other bone related tissue during spinal and orthopedic procedures. ExcelsiusGPS® is intended for use as an aid for precisely locating anatomical structures and for the spatial positioning and orientation of an instrument holder or guide to be used by surgeons for navigating and/or guiding compatible surgical instruments in open or percutaneous procedures provided that the required fiducial markers and rigid patient anatomy can be identified on CT scans or fluoroscopy. The system is indicated for the placement of spinal and orthopedic bone screws and interbody fusion devices. ExcelsiusHub™ is intended for use as an aid for precisely locating anatomical structures to be used by surgeons for navigating compatible surgical instruments in open or percutaneous procedures provided that the required fiducial markers and rigid patient anatomy can be identified on CT scans or fluoroscopy. The system is indicated for the placement of spinal and orthopedic bone screws and interbody fusion devices.

VERZA™ High Speed Drills are electrical drill handpieces/attachments powered by a motor with a control unit and foot pedal, and may be navigated using ExcelsiusGPS® or ExcelsiusHub™. The navigated components are provided nonsterile and are reusable. Burs are provided sterile and are single-use.

CAPTIVATE® Compression Screws are indicated for use in adult and pediatric patients, for fracture repair and fixation, osteotomy, joint fusion, reconstruction and arthrodesis of bones appropriate for the size of the device. CAPTIVATE® VL Compression Screws are indicated for use in adult and pediatric patients, for fracture repair and fixation, osteotomy, joint fusion, reconstruction and arthrodesis of the phalanges, metacarpals, carpals, metatarsals, midfoot, hind foot, ankle, fibula, distal tibia, proximal tibia, radius, ulna, humerus, and clavicle.

CAPTIVATE® Compression Screws consist of bone screws designed to compact juxtaposed bone for reconstruction and enhanced arthrodesis. The implants are available in various diameters and lengths to accommodate patient anatomy, with headless, partially or fully threaded, solid or cannulated, and variable length (VL) options. CAPTIVATE® implants are manufactured from titanium alloy, cobalt chromium molybdenum alloy, or stainless steel, as specified in ASTM F136, F1295, F1472, F1537, and F138.

CORBEL™ Spacers are integrated anterior lumbar interbody fusion devices indicated for use at one or more levels of the lumbosacral spine (L1-S1), as an adjunct to fusion in patients with the following indications: degenerative disc disease (DDD), disc hemiation (with myelopathy and/or radiculopathy), spondylolisthesis, deformity (degenerative scoliosis or kyphosis), spinal stenosis, and failed previous fusion (pseudarthrosis). 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. CORBEL™ Spacers are intended to be used with or without three screws and/or anchors which accompany the implants. These devices are intended for use with supplemental fixation (e.g. facet screws or posterior fixation). In addition, these devices are intended for stand-alone use in patients with DDD at one or two levels only when <25° lordotic implants are used with three screws per implant. CORBEL™ Spacers are to be filled with autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone.

CORBEL™ Spacers are integrated anterior lumbar interbody fusion devices used to provide structural stability in skeletally mature individuals following discectorny. The spacers are available in various heights and geometric options to fit the anatomical needs of a wide variety of patients. Protrusions on the superior and inferior surfaces of the device grip the endplates of the adjacent vertebrae to aid in expulsion resistance. Screws and/or anchors are inserted through the anterior portion of the implant into adjacent vertebral bodies for bony fixation. CORBEL™ Spacers are manufactured from titanium alloy, as specified in ASTM F136. The mating screws and anchors are manufactured from titanium alloy, per ASTM F136 and F1295, and/or cobalt chrome alloy, per ASTM F1537. Titanium screws and anchors are available with or without hydroxyapatite (HA) coating, per ASTM F1185.

The CREO® Stabilization 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 (including small stature) and for pediatric patients. These devices are indicated as an adjunct to fusion for the following indications: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, tracture or dislocation), deformities or curvatures (i.e., scoliosis, and/or lordosis, Schevermann's Disease), tumor, stenosis. and failed previous fusion (pseudoarthrosis). When used as an adjunct to fusion, the CREO® Stabilization System is intended to be used with autograft and/or allograft. In addition. the CREO® Stabilization System is intended for treatment of severe spondylolisthesis (Grades 3 and 4) of the LS-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 implants after 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 CREO® Stabilization System implants are indicated as an adjunct to treat adolescent idiopathic scoliosis. The CREO® Stabilization System is intended to be used with autograft and/or allograft. Pediatic pedicle screw fixation is limited to a posterior approach. In order to achieve additional levels of fixation, the CREO® Stabilization System rods may be connected to the REVERE® Stabilization System (4.5mm, 5.5mm, or 6.35mm rod) or ELLIPSE® Occipito-Cervico-Thoracic Spinal System (3.5mm rod) using corresponding connectors. Refer to the REVERE®, or ELLIPSE® system package insert for instructions and indications of use. In-Line Connector Growing Rods are indicated in patients under 10 years of age with potential for additional spine growth who require surgical treatment to obtain and maintain correction of severe, progressive, life-threatening, early onset spinal deformities associated with thoracic insufficiency, including early onset scoliosis, as part of a growing rod construct. Globus Navigation Instruments are intended to be used during the preparation and placement of CREO® 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 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 skull, a long bone, or vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy. Globus Navigation Instruments are intended to be used during the preparation and placement of Globus screws (OUARTEX®, CREO®, REVERE®, REVOLVE®, ELLIPSE®, PROTEX® CT, and SI-LOK®) 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 Medronic 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 skull, a long bone, or vertebra, can be identified relative to a CT or MRI based model, fluoroscopy images, or digitized landmarks of the anatomy. The ExcelsiusGPS® is intended for use as an aid for precisely locating anatomical structures and for the spatial positioning and orientation of an instrument holder or guide tube to be used by surgeons for navigating and/or guiding compatible surgical instruments in open or percutaneous procedures provided that the required fiducial markers and rigid patient anatomy can be identified on CT scans or fluoroscopy. The system is indicated for the placement of spinal and orthopedic bone screws.

CREO® Preferred Angle Screws are polyaxial screws with a preferred angle in one direction. They are composed of titanium alloy or cobalt chrome molybdenum alloy as specified in ASTM F136 and F1537, and are available with optional hydroxyapatite (HA) coating per ASTM F1185. Navigation Instruments are nonsterile, reusable instruments that can be operated manually or under power using a power drill that are intended to be used with the Medtronic StealthStation® System. ExcelsiusGPS® Instruments are nonsterile, reusable instruments that can be operated with the ExcelsiusGPS® robotic arm, or may be used for a freehand navigated surgical procedure.

The ASSURE® Anterior Cervical Plate System is intended for anterior screw fixation to the cervical spine C2-C7 for the following indications: degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumors, deformity (defined as kyphosis, lordosis, or scoliosis), pseudarthrosis, failed previous fusion, spondylolisthesis, and spinal stenosis.

ASSURE®-T Translational Anterior Cervical Plates are anterior cervical plates that allow translation for intraoperative graft compression and postoperative settling. The plate attaches to the anterior portion of the vertebral body of the cervical spine (C2-C7) using standard ASSURE® screws. The implants are manufactured from titanium alloy, as specified in ASTM F136 and F1295.

FORTRESS™ Radiopaque Bone Cement (FORTRESS™ and FORTRESS-Plus™) is indicated for the fixation of pathological fractures of the vertebroplasty or kyphoplasty procedures. Painful vertebral compression fractures may result from osteoporosis, benign lesions (hemangioma), and malignant lesions (metastatic cancers, myeloma). When used in conjunction with CREO® or REVLOK® Fenestrated Screw Systems for posterior fixation, FORTRESS™ Radiopaque Bone Cement is intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the thoracic and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion. FORTRESS™ Radiopaque Bone Cement is limited to use at spinal levels where the structural integrity of the spine is not severely compromised. CREO® Fenestrated Screw System, when used as a posterior pedicle screw system, is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the following acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, spinal tumor, pseudoarthrosis and failed previous fusion. In addition, the CREO® Fenestrated Screw System is intended for treatment of severe spondylolisthesis (Grades 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 implants after attainment of a solid fusion. Levels of pedicle screw fixation for these patients are L3-sacrum/ilium. When used as an anterolateral thoracolumbar system, the CREO® Fenestrated Screw System is intended for anterolateral screw (with or without staple) fixation for the following indications: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spinal stenosis, spondylolisthesis, spinal deformities (i.e. scoliosis, kyphosis), fracture or dislocation of the thoracolumbar spine, pseudoarthrosis, tumor resection, and/or failed previous fusion. Levels of screw fixation are T8-L5. When used for posterior fixation in conjunction with FORTRESS-Plus™ bone cement, the CREO® Fenestrated Screw System is intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the thoracic and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion. CREO® Fenestrated with FORTRESS™ or FORTRESS-Plus™ bone cement are intended for use at spinal levels where the structural integrity of the spine is not severely compromised. REVLOK® Fenestrated Screw System, when used as a posterior pedicle screw system, is intended 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 (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, scoliosis, kyphosis, spinal tumor, pseudoarthrosis and failed previous fusion. In addition, the REVLOK® Fenestrated Screw System is intended for treatment of severe spondylolisthesis (Grades 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 implants after attainment of a solid fusion. Levels of pedicle screw fixation for these patients are L3-sacrum/ilium. When used as an anterolateral thoracolumbar system, the REVLOK® Fenestrated Screw System is intended for anterolateral screw (with or without staple) fixation for the following indications: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spinal stenosis, spondylolisthesis, spinal deformities (i.e. scoliosis, and/or lordosis), fracture or dislocation of the thoracolumbar spine, pseudoarthrosis, tumor resection, and/or failed previous fusion. Levels of screw fixation are T8-L5. When used for posterior fixation in conjunction with FORTRESS™ or FORTRESS-Plus™ bone cement, the REVLOK® Fenestrated Screw System is intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the thoracic and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion. REVLOK® Fenestrated with FORTRESS™ or FORTRESS-Plus™ bone cement are intended for use at spinal levels where the structural integrity of the spine is not severely compromised.

1) FORTRESS™ Radiopaque Bone Cement: FORTRESS™ Radiopaque Bone Cements (FORTRESS™, FORTRESS-Plus™) are radiopaque, self-curing PMMA bone cements. FORTRESS™ is provided as two sterile components, a liquid component and a powder component, which are mixed together prior to use to form the cement. The bone cement is intended for single use only. 2) CREO® Fenestrated Screw System: CREO® Fenestrated Screw System consists of fenestrated monoaxial screws, uniplanar screws, polyaxial screws, dual outer diameter screws, reduction screws, rods and locking caps. Screws are available in a variety of sizes to accommodate individual patient anatomy. CREO® Fenestrated Screws mate with 4.75mm, 5.5mm, and 6.35mm diameter rods and connecting components from the CREO® Stabilization System. In addition, CREO Threaded screws and locking caps mate with 6.0mm diameter rods. Implant components can be rigidly locked into a variety of configurations for the individual patient and surgical condition. Polyaxial screws are intended for posterior use only. Staples are intended for anterior use only. Monoaxial screws may be used anteriorly or posteriorly. Locking caps are used to connect screws to the rod. CREO® Fenestrated Screws are composed of titanium alloy, cobalt chromium molybdenum alloy, or stainless steel as specified in ASTM F136, F1537, F1295, F67 and F138. Due to the risk of galvanic corrosion following implantation, stainless steel implants should not be connected to titanium, titanium alloy, or cobalt chromium molybdenum alloy implants. CREO® Fenestrated Screws are available with or without hydroxyapatite (HA) coating, as specified in ASTM F1185. REVLOK® Fenestrated Screw System: The REVLOK® Fenestrated Screw System consists of monoaxial screws, uniplanar screws, polyaxial screws, dual outer diameter screws, reduction screws, rods and locking caps. Screws and rods are available in a variety of sizes to accommodate individual patient anatomy. REVLOK® implants mate with 5.5mm diameter rods and REVLOK® 6.35 implants mate with 6.35mm diameter rods, and connecting components from the REVERE® Stabilization System. Implant components can be rigidly locked into a variety of configurations for the individual patient and surgical condition. Locking caps are used to connect the screws to the rod. The rods are composed of titanium alloy, commercially pure titanium, cobalt chromium molybdenum alloy, or stainless steel, as specified in ASTM F136, F1295, F67, F1537 and F138. All other REVLOK® implants are manufactured from titanium alloy or stainless steel, as specified in ASTM F136, F1295, F138, and F67. Due to the risk of galvanic corrosion following implantation, stainless steel implants should not be connected to titanium or titanium alloy implants. The REVLOK® Fenestrated Screws are available with or without hydroxyapatite (HA) coating, as specified in ASTM F1185.