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The HipXpert system is a manual surgical instrument and associated software application designed for use in planning surgery and aligning the acetabular components during hip arthroplasty procedures. The Hiplnsight system with the HoloLens2 is indicated for visualization of the HipXpert surgical plan and alignment of acetabular implants and instrumentation during hip arthroplasty when pin-based fixation of the HipXpert tools is utilized.

The Hiplnsight System was cleared in K200384 and utilizes the Microsoft HoloLens2 mixed reality headset to display 3D images from the HipXpert planning application. The 3D images are superimposed on the actual patient using known anchoring landmarks relative to the anterior pelvic plane. The HipXpert software planning application uses CT patient image data to create a detailed 3D model of the pelvis as well as the instrument settings necessary for proper acetabular cup orientation. The HipXpert planning application has the ability to show implant and instrument templates that are either generic or manufacturer specific. The templates can be positioned in relation to the patient's pelvis and femur bones in the surgical plan. The surgical plan, including all tool settings and usage instructions, is posted to the surgeon's secure folder on the HipXpert website. The operating surgeon can then download the plan to a desktop or laptop computer and use the HipXpert viewer application to view and adjust the plan according to his/her best surgical judgment. The purpose of this submission is to introduce additional options for the Hiplnsight system. Additional surgeon needs include being able to: - Use mixed-reality guidance with additional 3D objects - Use mixed-reality quidance without using the HipXpert mechanical docking tools - Use mixed-reality guidance that provides position accuracy in addition to orientation accuracy - Use mixed-reality guidance for limb length measurements

The HipXpert system is a manual surgical instrument and associated software application designed for use in planning surgery and aligning the acetabular components during hip arthroplasty procedures. The HipXpert 3D Display and Anchoring application with the HoloLens2 is indicated for visual alignment of an acetabular cup impactor during hip arthroplasty when pin-based fixation of the HipXpert tool is utilized.

The HipXpert system provides a patient-specific hip arthroplasty surgical plan allowing for accurate acetabular positioning using CT mapping of a patient's pelvis using a software application and a reusable, manual, mechanical navigation instrument. The HipXpert software planning application uses patient image data to create a detailed 3D model of the pelvis as well as the instrument settings necessary for proper acetabular cup orientation. The HipXpert mechanical instrument has three legs which are secured to the pelvis. The legs form three points which define the sextant plane. The HipXpert mechanical instrument has two protractors that are adjusted to orientate an indicator pin in the direction of the desired orientation of the acetabular component. The subject HipXpert 3D Display and Anchoring Application utilizes the previously cleared (K093491) HipXpert planning application and HipXpert tools in addition to a mixed reality headset (Microsoft HoloLens2) and QR target. The HoloLens2 is an off-the-shelf component developed and manufactured by Microsoft which is used to view superimposed 3D images from the HipXpert planning application on the real HipXpert tool. In order to properly orient the 3D images displayed by the HoloLens2, a QR target is used to anchor these 3D images in space as they are overlaid on the real HipXpert tool.