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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 (e.g. 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 - Register hand gestures as inputs such as to touch, move and resize views - Wireless connectivity between a HMD (e.g. HoloLens 2) and the ROSA® RECON Platform

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-overative 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. Modifications have been made to some of the applications to improve the overall workflow: however, the patient specific guides and bone models remain unchanged from the predicate. In addition, modifications have been made to the user interface of the planning application.

Efficient Care 3D Planning is software indicated for assisting orthopedic surgeons in preoperative planning of knee orthopedic surgeries. The software allows for the overlaying of 3D/2D implant models and for the visualization of the radiological images and 3D reconstruction of bones, and includes tools for performing measurements on the images or 3D model of bones, and for selecting and positioning the implant model. Clinical judgments and experience are required to properly use the software. Efficient Care 3D Planning 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 CR-Flex Gender, NexGen LPS, NexGen LPS-Flex, NexGen LPS-Flex Gender, Persona® CR, Persona PS, Vanguard® CR, and Vanguard PS.

Efficient Care 3D Templating is software application that is intended to assist in the preoperative sizing of femoral and tibial implants. The software solution allows for the processing of multiple 2D X-rays to create 3D bone models that scales to patient bones and compensates for patient leg rotation in the X-rays images. The 3D bone models allow implant sizing to occur and output a template report, which includes overlays of prostheses, in respect to leg orientations on the X-ray images. Final implant sizing is based on intraoperative surgeon assessment.