Blueprint Mixed Reality system

Blueprint® Mixed Reality system is indicated for use during Total Shoulder Arthroplasty using Stryker's FDA cleared implants that are also implants cleared for pre-operative planning with the Blueprint® Software. Blueprint® Mixed Reality system is intended to allow surgeons to visualize the Blueprint® 3D preoperative planning intra-operatively. Blueprint® Mixed Reality system is also indicated for stereotaxic surgery to guide the placement of a glenoid pin provided that registration between the patient's anatomical landmarks / surfaces can be established on the preoperative CT based plan. Blueprint® Mixed Reality system is to be only used for skeletally matured adult patients.

Blueprint® Mixed Reality system is indicated for use during Total Shoulder Arthroplasty using Stryker's FDA cleared implants that are also implants cleared for pre-operative planning with the Blueprint® Software. Blueprint® Mixed Reality system is intended to allow surgeons to visualize the Blueprint® 3D preoperative planning intra-operatively. Blueprint® Mixed Reality system is also indicated for stereotaxic surgery to guide the placement of a glenoid pin provided that registration between the patient's anatomical landmarks / surfaces can be established on the preoperative CT based plan. Blueprint® Mixed Reality system is to be only used for skeletally matured adult patients.

The Blueprint® Mixed Reality system is used to intraoperatively display stereoscopic three-dimensional images of the Blueprint shoulder arthroplasty preoperative plan and to guide and enable the insertion of a pin following the reaming axis aimed at preparing the glenoid fossa surface to facilitate the placement of the implant. The Blueprint Mixed Reality system allows the user to both see the patient in real-time and their internal boney anatomy displayed on see-through screens of a head-mounted device (goggles). The Blueprint Mixed Reality system assists surgeons in visualizing stereoscopic three-dimensional images of the patient's boney anatomy and intraoperatively aid by guiding the pin during placement through real-time feedback. The Blueprint Mixed Reality system is composed of three main components including the HOLOBLUEPRINT software, Microsoft® HoloLens 2 Goggles, and Instrumentation. The Blueprint Mixed Reality system runs the HOLOBLUEPRINT software application on the Microsoft HoloLens 2 using Microsoft Windows Holographic Operating System. The Blueprint Mixed Reality system leverages the reference device by receiving planned glenoid cases as input for visualizing and guiding the placement of the pin during the shoulder arthroplasty procedure. The digital components of the system interface with specialized surgical instrumentation to enable intra-operative guidance through real-time feedback to the surgeon. The components of the subject device are as follows: HOLOBLUEPRINT™ Software, HoloLens 2 goggles (HoloLens 2), and Instrumentations (Instruments). The subject device is compatible with all Tornier (Stryker) commercially FDA-cleared glenoid implants (Except Patient Matched Implants) available in the reference device (K211359).