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JointVue's 3D Echo v1.1 is a software application for the display and 3D visualization of ultrasound volume data derived from the Terason uSmart3200T ultrasound system. It is designed to allow the user to observe images and perform analyses of musculoskeletal structures using the ultrasound volume data acquired with the Terason ultrasound scanner. Typical users of this system are trained medical professionals including physicians, nurses, and technicians.

JointVue's 3D Echo is a software application that uses the raw ultrasound signals generated from an imaging ultrasound machine to visualize musculoskeletal structures in three dimensions. The 3D Echo v1.1 includes the following device modifications from 3D Echo v1.0: - 1. software is updated for interoperability with Terason 3200T+ Ultrasound system - 2. the ultrasound hardware is Terason 3200T+ Ultrasound with Terason 14L3 Linear transducer instead of the SonixOne tablet-based portable ultrasound system - the NDI 3D Guidance driveBAY™ tracking unit is replaced by the 3D Guidance trakSTAR™ 3. tracking unit (same system but with an internal power supply)) - Different GCX system cart designed for Terason 3200T+ Ultrasound 4. - Custom transducer/sensor holder now attaches an 800 model EM sensor to the exterior of the ultrasound transducer - 6. Designed for use with medically approved probe cover

JointVue's ¡Fit Surgical Planner is a software device intended to assist medical professionals in preoperative planning of orthopedic surgery. The device allows for overlaying templates of prostheses on 3D bone models generated from radiological images. The software includes tools for performing measurements on the images and for positioning the prosthetic template. Clinical judgment and experience are required to properly use the software.

JointVue's ¡Fit Surgical Planner is an orthopedic preoperative planning software. It allows for overlaying templates of prostheses on patient 3D bone models generated from radiological images using JointVue's 3D echo software (K172513) for overlaying templates of prostheses for surgical preplanning of joint replacement surgery. jFit Surgical Planner is intended to run on a PC and requires the Microsoft Windows™ operating system, version 7, windows 8 or windows 10 (32-bit/64-bit). A PDF Reader such as Adobe Acrobat or Foxit is recommended in order to access the instructions for use. ¡Fit Surgical Planner software requires the following minimum requirements for computer hardware listed in the following table: Processor Intel Core i5-5300 @ 2.3 GHz or higher, Memory 8 GB RAM or more, Graphics Intel HD Graphics 5500 or higher, Resolution Minimum 1920*1080, HD Space 1 GB or more. The major functions and features of jFit Surgical Planner include: 1. Patient Case Loading, 2. Loading X-Ray Images, 3. Editing and Verifying Femur Landmarks, 4. Editing and Verifying Tibia Landmarks, 5. Conducting Femur Planning, 6. Conducting Tibia Planning, 7. Validating Surgical Planning, 8. Generation of a Surgical Planning Summary Report. iFit Surgical Planner is for installation on a secure computer workstation to protect patient data. Typical environment of use is an office environment. jFit Surgical Planner utilizes 3D bone models for preoperative planning of joint replacement surgery. Surgical preplanning starts by importing patient 3D bone models along with anterior-posterior and lateral X-Ray images, if available. ¡Fit Surgical Planner calculates relevant surgical landmarks which can then be verified and edited. ¡Fit Surgical Planner will suggest an initial implant selection and placement based on anatomical landmarks selected and verified by the clinician is responsible to adjust the implant selection and placement parameters to validate patient-specific surgical plan. Upon completion of surgical planning, a summary report is generated that must be signed by a physician to approve the surgical plan.

JointVue's 3D Echo is a software application for the display and 3D visualization of ultrasound volume data derived from the Sonix Ultrasound Scanner. It is designed to allow the user to observe images and perform analyses of musculoskeletal structures using the ultrasound volume data acquired with the Sonix Ultrasound Scamer. Typical users of this system are trained medical professionals including physicians, nurses, and technicians.

JointVue's 3D Echo is a software application that uses the raw ultrasound signals generated from an imaging ultrasound machine to visualize musculoskeletal structures in three dimensions. The 3D Echo software is pre-loaded on one of the following two ultrasound systems: 1) SonixOne, a tablet-based system; or 2) SonixTouch Q+ with linear transducer (BK Ultrasound model L14-5/38 GPS) and driveBAY™ tracking unit (Ascension Technology Corporation). There are also two electromagnetic (EM) sensors (Ascension 6DOF sensors, model 800, part #600786) included with the JointVue 3D echo software to identify the relative location of the ultrasound probe. Finally, there is a foot switch (stuete model MKF-2-MED GP25) included as an input device. The major software functions of the JointVue 3D Echo system include the following: 1) the ability to display axial, sagittal, coronal and oblique 2D images; 2) the ability to display the 3D surface of musculoskeletal structures; 3) the ability to display axial images with 3D visualization; and 4) the ability to provide contouring and US image visualization. The device is intended to be used in a clinical or hospital environment. JointVue's 3D Echo ultrasound system utilizes raw ultrasound signals to detect tissue interfaces and visualize joint anatomy in three dimensions. The system provides clinicians with three-dimensional models of the joint anatomy.