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The ONVOY Acetabular System is intended for use in reconstruction of the articulating surface of the acetabular portion of the hip that is severely disabled and/or very painful resulting from: 1. Non-inflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, and avascular necrosis. 2. Rheumatoid arthritis. 3. Correction of functional deformity. 4. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques. 5. Revision of previously failed total hip arthroplasty. 6. Dislocation risks. The ONVOY Acetabular System is used in conjunction with Globus/StelKast Hip Systems. The acetabular components of this hip system are intended for cementless fixation.

The ONVOY™ additional implants consist of acetabular shells, liners, and dual mobility liners and bearings that are used as part of a complete total hip system in conjunction with a femoral head and femoral stem in total hip arthroplasty. New femoral head sizes are also being introduced. Implants are available in various configurations and sizes to fit a wide variety of patient anatomy. Shells are available in a cluster-hole design, liners are available in hooded, non-hooded, and lateralized designs used in conjunction with ONVOY shells. Dual mobility polyethylene bearings are used with dual mobility liners. ONVOY™ acetabular shells are additively manufactured from titanium alloy powder per ASTM F3001. Acetabular liners and dual mobility bearings are manufactured from highly crosslinked ultra-high molecular weight polyethylene (UHMWPE) with Vitamin E. Dual mobility liners are manufactured from Cobalt Chrome (CoCr) alloy and femoral heads are manufactured from alumina matrix composite ceramic.

Pulse Navigation is intended as an intraoperative image-guided localization system in either open or minimally invasive spinal surgical procedures. Instruments and implants tracked by a passive marker sensor system are virtually displayed on a patient's 3D radiographic image data. The system enables computer-assisted navigation for spinal surgical procedures in which the use of stereotactic surgery may be appropriate and where a reference to a rigid anatomical structure can be identified relative to the acquired image of the anatomy. This may include the following spinal implant procedures: - Pedicle Screw Placement (cervical, thoracic, lumbar) - Iliosacral screw placement

The subject device, Pulse ICT Adapter is introducing compatibility based on the design of existing fria patient reference hardware, the Spinous Process Clamp (Pulse System K210574) and Globus Medical 1CT Fixture (ExcelsiusGPS K171651 and K 191100). The subject device, Pulse ICT Adapter was designed to offer surgeons more flexibility during the registration process of Pulse Navigation by providing an additional patient reference hardware design option by attaching Globus Medical Intra-Op CT Fixture to the following: existing Articulating Arm and Bedrail Clamp. Despite the changes introduced to predicate Spinous Process Clamp (K210574), the subject device is substantially equivalent to the predicate as demonstration and validation testing performed using well established and previously cleared test methods. The Pulse System is a medical device consisting of Pulse LessRay, and Pulse Navigation. The Pulse System hardware includes a control unit, as well as accompanying accessory components. The Pulse NVM5 is a medical device that is intraoperative neurological monitoring and status assessment during spinal surgery. The device provides information directly to the surgeon, to help assess a patient's neurological status. The Pulse NVMS provides this information by electrically stimulating nerves via electrodes located on surgical accessories and monitoring electromyography (EMG), motor evoked potential (MEP) or somatosensory evoked potential (SSEP) responses of the muscle groups innervated by the nerves. Moreover, a Twitch Test ("Train of Four") function is utility of the nerve to respond, or contract, following four stimulation pulses to determine the presence of neuromuscular block. Additionally, the Pulse NVM5 System includes a software function that measures spinal parameters and acquires the location of spinal implants (screws, hooks) to assist the surgeon in bendini). Lastry, the Pulse NVMS provides Remote Access in two pathways, Local Wireless Control and Remote Monitoring. Pulse LessRay is a software application which can be interfaced to a fluoroscope with a video cable. The images produced by the fluoroscope are transmitted to a frame grabber in the computer running LessRay where the images are enhanced and then displayed. When used in connection with the low dose and/or pulse setting on the fluoroscope, the user can improve the quality (clarity, contrast, noise level, and usability) of a noisy (low-quality) image. Using this system, much of the graininess of low radiation dose images can be eliminated. This allows for greater utility of low dose imaging. LessRay provides the additional feature of being able to interface LessRay with a tracking system in order to aid the C-arm technician in positioning the fluoroscope between the various views of the patient necessary for the intervention. LessRay with Tracking ensures that the fluoroscope is centered over the correct anatomy prior to taking any additional x-ray images. Pulse Navigation is a stereotactic surgical as an aid for precisely locating anatomical structures in either open or percutaneous procedures. It is intended for intraoperative image-guided localization which allows for surgical instruments to be tracked in three-dimensional space. The device provides real-time information directly to the surgeon to evaluate the instrument depth and trajectory for computer-assisted navigation during spine surgery. Instruments are tracked in threedimensional space with an Infrared (IR) Camera, being virtually displayed and superimposed on registered radiographic images. Radiographic images are in the form of 3D intraoperative scan (CT or Cone Beam CT). The reason for the submission is to introduce a new intra-operative CT (ICT) adapter for use with the ExcelsiusGPS ICT Registation Fixture for the Pulse Navigation application.

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 ACTIFY™ Unicondylar Knee System is indicated for unicompartmental knee replacement due to the following conditions: 1. Moderately disabling joint disease of the knee resulting from painful osteo- and/or post-traumatic arthritis, or avascular necrosis. 2. Revision of previous unsuccessful unicompartmental knee replacement or other procedure. 3. Alternative to tibial osteotomy in patients with unicompartmental osteoarthritis. 4. Previous tibial condyle or plateau fractures with loss of anatomy or function. 5. Varus or valgus deformities. These devices are indicated for cemented use only.

The ACTIFY™ Unicondylar Knee System implants consist of femoral and tibial implants that are used as part of a unicompartmental knee system for partial knee arthroplasty. Implants are available in various configurations and sizes to fit a wide variety of patient anatomy. ACTIFY Unicondylar femoral implants are manufactured from cobalt chrome alloy, tibial inserts are manufactured from ultra high molecular weight polyethylene (UHMWPE) with and without Vitamin E, and tibia trays are manufactured from titanium alloy.

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.

ACTIFY™ Total Knee System and ACTIFY™ 3D Total Knee System are indicated for single use only in skeletally mature individuals undergoing reconstruction of severely disabled and/or very painful joints. ACTIFY™ Total Knee System and ACTIFY™ 3D Total Knee System are indicated for total knee replacement due to osteoarthritis, osteonecrosis, rheumatoid arthritis, and/or post-traumatic degenerative problems, and revision of failed previous reconstructions where sufficient bone stock and soft tissue integrity are present. ACTIFY™ Total Knee System is indicated for cemented use only, except for the porous femoral component which is indicated for both cemented and uncemented use. ACTIFY™ 3D Total Knee System is indicated for cemented and uncemented use.

The ACTIFY™ 3D Total Knee System and ACTIFY™ Total Knee System implants consist of modular femoral, tibial, and patellar implants that are used as part of a complete knee system in total knee arthroplasty. Implants are available in various configurations and sizes to fit a wide variety of patient anatomy. Femoral components and tibial inserts are available in posterior-stabilized (PS) and cruciate-retaining (CR) designs. Femurs are manufactured from cobalt chromium alloy (CoCr) with a CoCr coating. Tibial inserts and patella implants are manufactured from ultrahigh molecular weight polyethylene (UHMWPE) with and without Vitamin E. ACTIFY™ 3D Total Knee tibia trays and the patella metal base are additively manufactured from titanium alloy powder per ASTM F3001. ACTIFY™ Total Knee tibia trays are manufactured from titanium alloy per ASTM F136.

ExcelsiusFlex™ when used in conjunction with ExcelsiusHub™ is intended for use as an aid for precisely locating anatomical structures and for spatial positioning and orientation of a tool holder to be used by surgeons for navigating and/or guiding compatible surgical instruments provided that the required fiducial markers and rigid patient anatomy can be identified on CT scans or directly acquired anatomical structures. The system is indicated to assist the surgeon in planning the position of the implant components and preparing the bony anatomy during orthopedic procedures. The Total Knee Arthroplasty (TKA) implant systems compatible with ExcelsiusFlex™ are GENflex2® and ACTIFY™ Total Knee System. The 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, fluoroscopy or directly acquired anatomical structures. The system is indicated for the planning of orthopedic devices and placement of spinal and orthopedic bone screws and interbody fusion devices.

The ExcelsiusFlex™ is a robotic positioning system with a computer controlled robotic arm, hardware and software that works in conjunction with ExcelsiusHub™ , to enable real time surgical navigation and robotic guidance using patient tracking arrays and a positioning camera. The system assists the surgeon in implant placement planning and intraoperative tracking of patient anatomy by locating anatomical structures and stereotaxic positioning of surgical instruments relative to patient CT images or directly acquired anatomical structures. The navigation and quidance system determines the registration or mapping between the virtual patient (points on the patient images) and the physical patient (corresponding points on the patient's anatomy), or directly acquired anatomical structures. Once this reqistration is created, the software positions the robotic arm on a planned resection plane. The ExcelsiusFlex™ is intended for stereotaxic surqery in surgical knee procedures to assist the surgeon in spatial positioning and orientation of a sagittal sawblade, planning the position of the femoral and tibial implants, and for bone preparation during total knee arthroplasty (TKA) procedures. The system constrains the position of the robotic arm to planned resection planes based on the pre-operative or intra-operative plans developed using ExcelsiusFlex™-TKA software on either the ExcelsiusHub™ or a planning laptop. ExcelsiusFlex™ instruments consist of patient tracking instruments, patient attachment instruments, navigation instruments, end effectors and end effector instruments. Patient attachment instruments provides a point of rigid fixation for the patient tracking instruments. Patient tracking instruments and navigated instruments incorporate unique array patterns with reflective markers, and are used to track patient anatomy and surgical instruments. End effectors attach to the distal end of the robotic arm and provide a rigid connection to the saw blade.

The TENSOR® Suture Button System is intended to be used as an adjunct in fracture repair involving metaphyseal and periarticular small bone fragments where screws are not indicated, and as an adjunct in external and intramedullary fixation systems involving plates and rods, with fracture braces and casting. Specifically, the TENSOR® implants are intended to provide fixation during the healing process for the following indications: Syndesmotic trauma, such as ankle syndesmosis fixation (syndesmosis disruptions), and as an adjunct in connection with trauma hardware for Weber B and C ankle fractures; fixation of dorsal distal radioulnar ligament (DRUL) disruptions; Acromioclavicular separations due to coracoclavicular ligament disruptions; Tarsometatarsal (TMT) injury, such as fixation of foot soft tissue separations due to a Lisfranc injury (Midfoot Reconstruction); Hallux Valgus reconstruction (correction) by providing for the reduction of 1st metatarsal intermetatarsal angle; and, Carpal Metacarpal (CMC) joint arthroplasty as an adjunct in the healing process.

The TENSOR® Suture Button System consists of metal buttons, a polymer suture, an optional washer, and instruments. The buttons are available in various sizes to accommodate varying patient anatomy and surgical needs. The buttons and washer are manufactured from titanium alloy or stainless steel, and the suture is manufactured from ultra high molecular weight polyethylene (UHMWPE) and polyethylene terephthalate (PET). The implants are sterile packaged with various instruments to aid in insertion.

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.