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The ROSA Knee System, for use with the ROSA® RECON platform, is indicated as a stereotaxic instrumentation system for total knee replacement surgery. It is to assist the surgeon in providing software-defined spatial boundaries for orientation and reference information 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 based surgical planning tools. It includes a robotic arm, an optical tracking system and accessories, software system, surgical instruments and accessories.

The ROSA Knee System is designed for use on skeletally mature patient population. 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, Persona Ti-Nidium® CR, Persona Ti-Nidium PS, Persona® PPS® CR, Persona® PPS® PS, Persona SoluTion PPS, Persona IQ® The Smart Knee™, Vanguard® CR, and Vanguard PS.

The ROSA® Knee System for use with the ROSA® RECON platform 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 Non-Device Medical Device Data System (MDDS) called the Zimmer Biomet Portal which manages the creation and tracking of surgical cases. The cases reside on the portal until they are uploaded to the ROSA® RECON Platform before surgeries.

If the case is image-based, a 3D virtual bone model is generated pre-operatively by the PSI system (X-PSI Knee System K171269) to create a 3D model of the patient's femur/tibia and allows 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. 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 intraoperative workflow and surgical concepts implemented in the ROSA Knee 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.

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ExcelsiusGPS™
ExcelsiusGPS™ is intended for use as an aid for precisely locating anatomical structures and for the spatial positioning and orientation of an instrument holder or guide tube to be used by surgeons for navigating and/or guiding compatible surgical instruments in open or percutaneous procedures provided that the required fiducial markers and rigid patient anatomy can be identified on CT scans or fluoroscopy. The system is indicated for the placement of spinal and orthopedic bone screws and interbody fusion devices.

ExcelsiusHub™
ExcelsiusHub™ is intended for use as an aid for precisely locating anatomical structures to be used by surgeons for navigating compatible surgical instruments in open or percutaneous procedures provided that the required fiducial markers and rigid patient anatomy can be identified on CT scans or fluoroscopy. The system is indicated for the placement of spinal and orthopedic bone screws and interbody fusion devices.

Subject ExcelsiusGPS™ instruments consist of verification adapters and surgical instruments, including interbody inserters and trials, that may be used manually or navigated with the use of ExcelsiusGPS™ or ExcelsiusHub™. The surgical instruments are used to prepare the implant site or implant the device. Instruments are non-sterile and reusable.

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The Firebird SI Navigation System instruments are intended to be used during the preparation and placement of Orthofix Firebird SI Fusion System screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. The Firebird SI Navigation instruments are specifically designed for use with the Medtronic StealthStation System, which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as a vertebra or pelvis can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks for the anatomy.

The Firebird SI Navigation System consists of manual, surgical instruments for use with the Medtronic StealthStation Navigation System via the NavLock Tracker and SureTrak II Large Passive Fighter to assist surgeons in locating anatomical structures in minimally invasive and open procedures for preparation and placement of Firebird SI Fusion System implants. This surgical imaging technology provides surgeons visualization for complex and MIS procedures and confirms the accuracy of advanced surgical procedures. Use of these navigation systems provides the surgeon access to real-time, multi-plane 3D images (and 2D images) providing confirmation of hardware placement. The Firebird SI Navigation System instruments are manufactured from Stainless Steel per ASTM F899 or ASTM A564.

The Firebird SI Navigation System instruments include the following:

• Screw Driver
• Drills
• MDT Inline Adapter

The Firebird SI Navigation System instruments are to be used with the following FDA cleared SeaSpine Spinal System:

• Firebird SI Fusion System

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The Navigated Instruments are intended to be used during preparation and placement of Medtronic Implants during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures.

The Navigated Instruments are specifically designed for use with the Medtronic StealthStation™ System, which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate and where reference to a rigid anatomical structure, such as a vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.

The Navigated Instruments are spine preparation instruments made of surgical grade stainless steel per ASTM F899. These instruments are specifically designed for use in procedures where the use of stereotactic surgery may be appropriate. When used with the appropriate Medtronic single-use sterile spheres the subject devices can be used as navigated surgical instruments with the Medtronic StealthStation™ System (Medtronic computer-assisted surgery system) to track the instruments in the surgical field.

Specialized cases and trays are available for optional use with the Navigated Instruments. They are manufactured from stainless steel per ASTM F899, aluminum per ASTM B209, and silicone. Ancillary non-navigated instrumentation is available for optional use with the Navigated Instruments. These instruments are not specifically intended to be used with the subject device.

The Navigated Instruments are provided non-sterile.

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The OsteoCentric Navigated Instruments are intended to be used during the preparation and placement of OsteoCentric Pedicle Fasteners during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open, minimally invasive, or percutaneous procedures. The OsteoCentric Navigated Instruments are specifically designed for use with the Medtronic StealthStation® System, which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate and where reference to a rigid anatomical structure, such as a vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks for the anatomy.

The OsteoCentric Navigated Instruments System is a set of reusable surgical instruments for use with the Medtronic® StealthStation™ S8 Navigation System to assist surgeons in precisely locating anatomical structures in either open or percutaneous procedures for the placement of pedicle screws. The OsteoCentric Navigated Instruments are intended for use with the OsteoCentric Pedicle Fasteners Additionally, the submission includes a hybrid technique for placement of the Integrity SI® Fusion implants.

The OsteoCentric Navigation Instrument System includes navigated probes, taps, drills, and drivers and are manufactured from medical grade stainless steels per ASTM F899, ASTM F276, and ASTM F138.

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The StealthStation™ System, with StealthStation™ Spine Software, is intended as an aid for precisely locating anatomical structures in either open or percutaneous neurosurgical and orthopedic procedures in adult and skeletally mature pediatric (adolescent) patients. Their use is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the spine or pelvis, can be identified relative to images of the anatomy.

This can include the following spinal implant procedures in adult patients, such as:

• Pedicle Screw Placement
• Iliosacral Screw Placement
• Interbody Device Placement

This can include the following spinal implant procedures in skeletally mature pediatric (adolescent) patients:

• Pedicle Screw Placement

StealthStation S8 Spine Software helps guide surgeons during spine surgical procedures. The subject software works in conjunction with a navigation system, surgical instruments, a referencing system, and computer hardware. Navigation tracks the position of instruments in relation to the surgical anatomy and identifies this position on pre-operative or intraoperative images of the patient. The mouse, keyboard, touchscreen monitor, and footswitch of the StealthStation platforms are used to move through the software workflow. Patient images are displayed by the software from a variety of perspectives (axial, sagittal, coronal, oblique) and 3-dimensional (3D) renderings. During navigation, the system identifies the tip location and trajectory of the tracked instrument on images and models the user has selected to display on the monitor. The surgeon may also create and store one or more surgical plan trajectories before and during surgery and simulate progression along these trajectories. During surgery, the software can display how the actual instrument tip position and trajectory relate to the plan, helping to guide the surgeon along the planned trajectory.

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The TMINI® Miniature Robotic System is indicated as a stereotaxic instrumentation system for total knee replacement (TKA) surgery. It is to assist the surgeon by providing software-defined spatial boundaries for orientation and reference information to identifiable anatomical structures for the accurate placement of knee implant components.

The robotic device placement is performed relative to anatomical landmarks as recorded using the system intraoperatively and based on a surgical plan determined preoperatively using CT based surgical planning tools.

The targeted population has the same characteristics as the population that is suitable for the implant(s) compatible with the TMINI® Miniature Robotic System.

The TMINI® Miniature Robotic System is compatible with and to be used with the following knee replacement systems in accordance with the indications and contraindications:

• Enovis™ EMPOWR Knee System®
• Ortho Development® BKS® and BKS TriMax® Knee System
• Total Joint Orthopedics Klassic® Knee System
• United® U2™ Knee Total Knee System
• Medacta® GMK® Sphere / SpheriKA Knee Systems
• Zimmer Biomet Anterior & Posterior Referencing Persona® Knee
• b-ONE MOBIO® Total Knee System
• Maxx Orthopedics Freedom® Total & Titan Knee
• LINK® LinkSymphoKnee System

The TMINI® Miniature Robotic System (AIM 3.0) like its predicate, the TMINI® Miniature Robotic System consists of three primary components: a three-dimensional, graphical, Preoperative Planning Workstation with the TCM web based plan review, approval and download component, an Optical Tracking Navigation Console (TNav) and a robotically controlled hand-held tool (TMINI Robot) that assists the surgeon in preparing the bone for implantation of TKA components. This submission introduces modifications to the method of generation, verification and validation of new implant modules for use with the TMINI Miniature Robotic System.

The TPLAN Planning Station uses preoperative CT scans of the operative leg to create 3D surface models for case templating and intraoperative registration purposes. The Planning Workstation contains a library of 510(k) cleared knee replacement implant(s) available for use with the system. The surgeon can select an implant model from this library. The planner/surgeon can manipulate the 3D representation of the implant in relation to the bone model to optimally place the implant. The surgeon reviews and approves the case plan using either TPLAN or the TCM web-based application once the surgeon is satisfied with the implant selection, location and orientation. The data from the approved plan is written to a file that is used to guide the robotically controlled hand-held tool.

The hand-held robotic tool is optically tracked relative to optical markers placed in both the femur and tibia and articulates in two degrees-of-freedom, allowing the user to place bone pins in a planar manner in both bones. Mechanical guides are clamped to the bone pins, resulting in subsequent placement of cut slots and drill guide holes such that the distal femoral and proximal tibial cuts can be made in the pre-planned positions and orientations, and such that the implant manufacturer's multi-planer cutting block can be placed relative to drilled distal femoral pilot holes. If the surgeon needs to change the plan during surgery, it can be changed intraoperatively.

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