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OptiVu™ ROSA® MxR is indicated for displaying surgical workflow images from the ROSA® RECON platform in Mixed Reality. It includes functions for viewing the same surgical workflow steps and 2D visualizations as presented on the existing ROSA RECON platform user interface. When accessing ROSA® MxR from a stereoscopic head mounted display (HMD), images viewed are for informational purposes only and are not intended for diagnostic use.

OptiVu™ ROSA® Mixed Reality (ROSA® MxR) is indicated for displaying surgical workflow images from the ROSA® RECON Platform and the corresponding ROSA® clinical applications intra-operatively during orthopedic surgeries. It is intended to provide an additional means of display where the ROSA® RECON Platform user interface is duplicated into a Mixed Reality see-through environment. OptiVu™ ROSA® MxR allows the ROSA® RECON Platform user interface and corresponding ROSA® clinical applications (ROSA Knee, ROSA Partial or ROSA Hip) to be streamed through a compatible head-mounted display (HMD) (e.g. HoloLens 2). The subject device's main purpose is to place the duplicated virtual ROSA® user interface at a convenient location to provide the following functionalities: ● Mixed Reality visualization solution Wireless connectivity between a HMD (e.g. HoloLens 2) . and the ROSA® RECON Platform Interaction with the duplicated user interface and ● RECON Platform (e.g. voice, eye gaze and hand gestures)

The Signature™ ONE System is indicated, based on patient-specific radiological images with identifiable placement anatomical landmarks, to assist in pre-operative planning and/or intra-operative guiding of surgical instruments for shoulder replacement surgical procedures on patients not precluded from being radiologically scanned. The Signature™ ONE System is to be used with the glenoid components of the following shoulder implant systems in accordance with their indications and contraindications: Zimmer® Trabecular Metal™ Reverse Plus Shoulder, Comprehensive® Total Shoulder System, Comprehensive® Reverse Shoulder System, Comprehensive® Reverse Augmented Baseplates and Alliance™ Glenoid System. The Signature™ ONE Guides and bone models are intended for single use only.

The Signature™ ONE System is developed to assist in preoperative planning of the glenoid component for Total Shoulder Arthroplasty (using the Signature™ ONE Planner) and to accurately transfer a pre-operative plan to orthopedic surgical procedures (using the Signature™ ONE Guides) if desired. Both anatomic and reverse (TSA and RSA respectively) approaches are supported. The Signature ONE Guides and Bone Model are designed and manufactured of polyamide (nylon) using additive manufacturing (selective laser sintering), based on the approved/finalized pre-surgical plan and shipped prior to surgery. The guides and bone models are provide nonsterile and sterilized at the hospital. They are used intraoperatively to assist the surgeon in reproducing the plan. The Signature ONE System surgical technique remains close to the conventional shoulder arthroplasty to allow converting to standard surgical technique at any time if needed during the operation. The Signature™ ONE System uses the Zimmer Biomet Drive Portal for the interaction with external users (i.e. imaging technician and the surgeon). The internal users (i.e. the Zimmer Biomet operators) use manufacturing software applications to prepare the patient cases for the surgeon. Modifications have been made to include guides and bone models for the Alliance Glenoid System, to the planning application and user interface, and the inclusion of an additional glenosphere size for the Comprehensive Reverse Implant System within the Signature™ ONE planning software application. The overall planning process, manufacturing process, materials, sterilization methods, principal of operation, have not changed from previous predicates.

The Signature™ ONE System is indicated, based on patient-specific radiological images with identifiable placement anatomical landmarks, to assist in pre-operative planning and/or intra-operative guiding of surgical instruments for shoulder replacement surgical procedures on patients not precluded from being radiologically scanned. The Signature™ ONE System is to be used with the glenoid components of the following shoulder implant systems in accordance with their indications and contraindications: Zimmer® Trabecular Metal™ Reverse Plus Shoulder, Comprehensive® Total Shoulder System, Comprehensive® Reverse Shoulder System, Comprehensive® Reverse Augmented Baseplates and Alliance™ Glenoid System. The Signature™ ONE Guides and bone models are intended for single use only.

The Signature™ ONE System is developed to assist in preoperative planning of the glenoid component for Total Shoulder Arthroplasty (using the Signature™M ONE Planner) and to accurately transfer a pre-operative plan to orthopedic surgical procedures (using the Signature™ ONE Guides) if desired. Both anatomic and reverse (TSA and RSA respectively) approaches are supported. The Signature ONE Guides and Bone Model are designed and manufactured of polyamide (nylon) using additive manufacturing (selective laser sintering), based on the approved/finalized pre-surgical plan and shipped prior to surgery. The guides and bone models are provide nonsterile and sterilized at the hospital. They are used intraoperatively to assist the surgeon in reproducing the plan. The Signature ONE System surgical technique remains close to the conventional shoulder arthroplasty to allow converting to standard surgical technique at any time if needed during the operation. The Signature™ ONE System uses the Zimmer Biomet Drive Portal for the interaction with external users (i.e. imaging technician and the surgeon). The internal users (i.e. the Zimmer Biomet operators) use manufacturing software applications to prepare the patient cases for the surgeon. Modifications have been made to Planning application to include Alliance™ Glenoid implant system as a Pure Planning option (i.e. no Guides and Bone Models). In addition, modifications have been made to the user interface of the overall planning application. The planning process, manufacturing process, materials, sterilization methods, principal of operation, have not changed from previous predicates.

The iASSIST Knee System is a computer assisted stereotaxic surgical instrument system to assist the surgeon in the positioning of orthopedic implant system components intra-operatively. It involves surgical instruments and position sensors to determine alignment axes in relation to anatomical landmarks and to precisely position alignments and implant components relative to these axes. Example orthopedic surgical procedures include but are not limited to: Total Knee Arthroplasty.

As in the predicates, the iASSIST Knee System consists of Pods (tracking sensors), a computer system, software, and surgical instruments designed to assist the surgeon in the placement of Total Knee Replacement components. The Pods combined with the surgical instruments provide positional information to help orient and locate the main femoral and tibial cutting planes as required in knee replacement surgery. This includes means for the surgeon to determine and thereafter track each of the bones' alignment axes relative to which the cutting planes are set. The computer system and software components control and sequence the functions of the Pods per the applicable knee surgery steps via wireless communication.

The Signature™ ONE System is indicated, based on patient-specific radiological images with identifiable placement anatomical landmarks, to assist in pre-operative planning and/or intra-operative guiding of surgical instruments for shoulder replacement surgical procedures on patients not precluded from being radiologically scanned. The Signature™ ONE System is to be used with the glenoid components of the following shoulder implant systems in accordance with their indications: Zimmer® Trabecular Metal™ Reverse Plus Shoulder, Comprehensive® Total Shoulder System, Comprehensive® Reverse Shoulder System and Comprehensive® Reverse Augmented Baseplates. The Signature™ ONE Guides and bone models are intended for single use only.

The Signature™ ONE System is developed to assist in pre-operative planning of the glenoid component for Total Shoulder Arthroplasty (using the Signature™ ONE Planner) and to accurately transfer a pre-operative plan to orthopedic surgical procedures (using the Signature™ ONE Guides) if desired. Both anatomic and reverse (TSA and RSA respectively) approaches are supported. The Signature ONE Guides and Bone Model are designed and manufactured of polyamide (nylon) using additive manufacturing (selective laser sintering), based on the approved/finalized pre-surgical plan and shipped prior to surgery. The guides and bone models are provide nonsterile and sterilized at the hospital. They are used intraoperatively to assist the surgeon in reproducing the plan. The Signature ONE System surgical technique remains close to the conventional shoulder arthroplasty to allow converting to standard surgical technique at any time if needed during the operation. The Signature™ ONE System uses the Zimmer Biomet Drive Portal for the interaction with external users (i.e. imaging technician and the surgeon). The internal users (i.e. the Zimmer Biomet operators) use manufacturing software applications to prepare the patient cases for the surgeon.

The ROSA® Knee System is indicated as a stereotaxic instrumentation system for total knee replacement (TKA) surgery. It is to assist the surgeon in providing software-defined spatial boundaries for orientation to identifiable anatomical structures for the accurate placement of knee implant components. The robotic arm placement is performed relative to anatomical landmarks as recorded using the system intraoperatively, and based on a surgical plan, optionally determined pre-operatively using compatible X-ray or MRI based surgical planning tools. It includes a robotic arm, an optical sensor navigation system and accessories, software system, surgical instruments and accessories. The targeted population has the same characteristics as the population that is suitable for the implants compatible with the ROSA® Knee System. The ROSA® Knee System is to be used with the following fixed bearing knee replacement systems in accordance with their indications and contraindications: NexGen® CR, NexGen CR-Flex, NexGen CR-Flex Gender, NexGen LPS, NexGen LPS-Flex, NexGen LPS-Flex Gender, Persona® CR, Persona PS, Vanguard® CR, and Vanguard PS.

The ROSA® Knee System is used to assist surgeons in performing Total Knee Arthroplasty (TKA) with features to assist with the bone resections as well as assessing the state of the soft tissues to facilitate implant positioning intra-operatively. The ROSA® Knee System uses a Medical Device Data System (MDDS) called the Zimmer Biomet Drive Portal which manages the creation and tracking of surgical cases. The cases reside on the portal until it is uploaded to the ROSA® Knee System before surgeries. If the case is image-based, a 3D virtual bone model is generated pre-operatively by the PSI systems (X-PSI Knee System or CAS PSI Knee System) to create a model of the patient's femur/tibia and allows for the preparation of a pre-operative surgical plan as well as visualization of planned cuts. The pre-operative plan is then matched to the landmarks taken intra-operatively on the patient's bony anatomy. An imageless option is also available where landmarks taken intra-operatively on the patient's bony anatomy are used to create the surgical plan directly in the surgery. Accuracy of resections, knee state evaluation, and soft tissue assessment are the same between image-based and imageless options as they are always based on intra-operative landmarks. The intra-operative workflow and surgical concepts implemented in the system remain close to the conventional TKA workflow. As such, at the time of the surgery , the system mainly assists the surgeon in (1) determining reference alignment axes in relation to anatomical landmarks, (2) planning the orthopedic implants location based on these reference alignment axes and orthopedic implant geometry (planning optionally based on a pre-operative plan using pre-operative imaging),, and (3) precisely positioning the cut guide relative to the planned orthopedic implant location by using a robotic arm. It includes a robotic arm, an optical sensor navigation system and accessories, software system, surgical instruments and accessories.

The X-PSI Knee System is indicated as an orthopedic instrument system to assist in the positioning of knee replacement components. It involves surgical planning software used pre-operatively to plan the surgical placement of the components on the basis of provided patient radiological images and 3-D reconstructed bones with identifiable placement anatomical landmarks, and surgical instrument components that include patient specific or customized guides fabricated on the basis of the surgical plan to precisely reference the placement of the implant components intra-operatively per the surgical plan. The X-PSI Knee system is indicated for patients without severe bone deformities, such as a HKA greater than 15° or deformities due to prior fracture of the distal femur or proximal tibia. The X-PSI Knee System is to be used with the following fixed bearing knee replacement systems in accordance with their indications and contraindications: NexGen® CR, NexGen CR-Flex Gender, NexGen LPS, NexGen LPS-Flex, NexGen LPS-Flex Gender, Persona® CR, Persona PS, Vanguard® CR and Vanguard PS. The patient specific guide components are intended for single-use only.

The present Zimmer Biomet® X-PSI Knee System is an instrumentation system that includes customized surgical guides to mate each patient's bony and articular surface topographies to reference the location and orientation of the implant system's instruments which in turns sets the position and alignment of the femoral and tibial implant components. It involves the following: - A CAS X-PSI Knee Software Suite used in preparation for the surgery to sequentially construct 3-D surface models of each patient's knee joint bony structures and articular surfaces from the patient's X-Ray images, plan the location and orientation of the knee replacement implant components upon the patient's model, and create the corresponding specification models for the patient specific surgical guides (PSI Guides) with surfaces and elements to uniquely fit each patient topographical features and set or reference the placement of the implant system components per the plan, - . The Zimmer Biomet ® X-PSI Guides (also called jigs) that are manufactured per the above models and plan, for intra-operative and single use, which include one to set the placement of the distal femoral cut guides which set the resection depth, the varus/valgus and the flexion of the distal cut and one to set the placement of the tibial cut guides which set the resection depth, the varus/valgus, and the posterior slope of the proximal cut. - . Each patient's Zimmer Biomet ®3-D Bone Models (femur and tibia components) that are fabricated and provided along with the PSI Guides for use intra-operatively to provide the surgeon with an intra-operative visual reference of the planned location of the PSI Guides in order to help guide their locations on the patient's actual joint, - Zimmer Biomet X-PSI Reusable Surgical Instrumentations are provided both sterile . and non-sterile and are reusable for intra-operative use, which include femoral stylus, and femoral and tibial cut block instrumentations to allow setting the resection level and performing the bone cuts as defined by the PSI Guides. - Fixation Pins are accessories for use of the guides, these accessories are Class I devices under the classification "Orthopedic manual surgical instrument (21 CFR § 888.4540)". The Zimmer Biomet® X-PSI Knee System is compatible for use with the following class II Zimmer Biomet Nexgen, Persona and Vanguard total knee replacement implant systems: - . NexGen®family: NexGen CR, NexGen CR-Flex, NexGen CR-Flex Gender, NexGen LPS, NexGen LPS-Flex, NexGen LPS-Flex Gender - . Persona® family: Persona CR, Persona PS - Vanguard® family: Vanguard CR, Vanguard PS Finally, the following accessories are used for the acquisition of the x-ray images: - X-Ray Marker 3D Zimmer Biomet ® X-PSI (re-usable) ● - X-Ray Calibration Straps, Short and Long (single-use)