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Intended Use CORIOGRAPH Pre-Op Planning and Modeling Services are intended to provide preoperative planning for surgical procedures based on patient imaging, provided that anatomic landmarks necessary for generating the plan are identifiable on patient imaging scans. Indications for Use The CORIOGRAPH Pre-op Planning and Modeling Services are indicated for use for the following procedures: - Unicondylar Knee Replacement (UKR) - Total Knee Arthroplasty (TKA) - Primary Total Hip Arthroplasty (THA) - Primary Anatomic Total Shoulder Arthroplasty (aTSA) - Primary Reverse Total Shoulder Arthroplasty (rTSA)

Coriograph Pre-Op Planning and Modeling Services (CORIOGRAPH) are Software as a Medical Device (SaMD) that provide pre-operative planning for orthopedic surgical procedures based on patient imaging, surgeon preferences and implant geometry. CORIOGRAPH is comprised of several medical software systems (modules), and these modules share a set of non-medical function software applications called the Case Processing System. CORIOGRAPH is a Software Medical Device System. The medical function modules share a graphic user interface where the surgeon provides their case preferences and patient imaging, retrieves PDF plans generated by the Pre-Op Plan modules, and launches the Modeler modules. #### CORIOGRAPH Pre-Op Plan Modules Using patient-specific information, patient imaging, and surgeon inputs, a pre-operative plan is generated by Smith+Nephew personnel. The plan provides initial alignment recommendations to the surgeon on implant placement based on the geometries of the implant and of the generated bone models. #### CORIOGRAPH Hip Modeler and CORIOGRAPH Shoulder Modeler Modules CORIOGRAPH Hip Modeler and CORIOGRAPH Shoulder Modeler are web-based software applications intended for surgeons to modify the patient-specific pre-operative plan and to evaluate the impact of the modifications through the impingement analysis tools such as Impingement-free Range-of Motion (ROM) and Activities of Daily Living (ADL) simulations.

Intended Use CORIOGRAPH Pre-Op Planning and Modeling Services are intended to provide preoperative planning for surgical procedures based on patient imaging, provided that anatomic landmarks necessary for generating the plan are identifiable on patient imaging scans. Indications for Use The CORIOGRAPH Pre-op Planning and Modeling Services are indicated for use for the following procedures: - · Unicondylar Knee Replacement (UKR) - · Total Knee Arthroplasty (TKA) - · Primary Total Hip Arthroplasty (THA)

The subject CORIOGRAPH Hip Pre-Op Plan and CORIOGRAPH Modeler are medical function modules within the CORIOGRAPH Pre-Op Planning and Modeling Services are additional offerings being introduced by Blue Belt Technologies, Inc. to allow for pre-operative planning for surgical procedures based on patient imaging for primary total hip arthroplasty (THA). The CORIOGRAPH Hip Pre-Op Plan system will utilize Smith and Nephew personnel to generate patient specific bone models and preoperative plans for primary THA which will be viewable and editable on CORIOGRAPH Modeler 1.0. Together, CORIOGRAPH Hip Pre-Op Plan and CORIOGRAPH Modeler are the subject of this submission.

REAL INTELLIGENCE CORI is indicated for use in surgical procedures, in which the use of stereotactic surgery may be appropriate, and where reference to rigid anatomical bony structures can be determined. These procedures include: · unicondylar knee replacement (UKR), · total knee arthroplasty (TKA), · revision knee arthroplasty, and · total hip arthroplasty (THA).

The subject of this Traditional 510(k) is REAL INTELLIGENCE CORI (CORI), a robotic-assisted orthopedic surgical navigation and burring system. CORI uses established technologies of navigation via a passive infrared tracking camera. For knee applications, CORI aids the surgeon in planning the surgical implant location and in executing the surgical plan by controlling the cutting engagement of the surgical bur. For knee applications, CORI software controls the cutting engagement of the surgical bur based on its proximity to the planned target surface. The cutting control is achieved with two modes: - Exposure control adjusts the bur's exposure with respect to a guard. If the surgeon encroaches on a portion of bone that is not to be cut, the robotic system retracts the bur inside the guard, disabling cutting. - o Speed control regulates the signal going to the tool control unit itself and limits the speed of the drill if the target surface is approached. Alternatively, the surgeon can disable both controls and operate the robotic drill as a standard navigated surgical drill.

CORI is indicated for use in surgical procedures, in which the use of stereotactic surgery may be appropriate, and where reference to rigid anatomical bony structures can be determined. These procedures include: - unicondylar knee replacement (UKR), - . total knee arthroplasty (TKA), - revision knee arthroplasty, and - . total hip arthroplasty (THA).

The subject of this Special 510(k) is REAL INTELLIGENCE CORI (CORI), a robotic-assisted orthopedic surgical navigation and burring system. CORI uses established technologies of navigation via a passive infrared tracking camera. Based on intraoperatively-defined bone landmarks and known geometry of the surgical implant, the system aids the surgeon in establishing a bone surface model for the target surgery and planning the surgical implant location. For knee applications, CORI then aids the surgeon in executing the surgical plan by controlling the cutting engagement of the surgical bur. CORI knee application software controls the cutting engagement of the surgical bur based on its proximity to the planned target surface. The cutting control is achieved with two modes: - . Exposure control adjusts the bur's exposure with respect to a guard. If the surgeon encroaches on a portion of bone that is not to be cut, the robotic system retracts the bur inside the guard, disabling cutting. - . Speed control regulates the signal going to the tool control unit itself and limits the speed of the drill if the target surface is approached. Alternatively, the surgeon can disable both controls and operate the robotic drill as a standard navigated surgical drill.

CORI is indicated for use in surgical procedures, in which the use of stereotactic surgery may be appropriate, and where reference to rigid anatomical bony structures can be determined. These procedures include unicondylar knee replacement (UKR), total knee arthroplasty (TKA), and total hip atthroplasty (THA).

The subject of this Traditional 510(k) is REAL INTELLIGENCE CORI (CORI), a robotic-assisted orthopedic surgical navigation and burring system. CORI uses established technologies of navigation via a passive infrared tracking camera. Based on intraoperatively-defined bone landmarks and known geometry of the surgical implant, the system aids the surgeon in establishing a bone surface model for the target surgery and planning the surgical implant location. For knee applications, CORI then aids the surgeon in executing the surgical plan by controlling the cutting engagement of the surgical bur. CORI knee application software controls the cutting engagement of the surgical bur based on its proximity to the planned target surface. The cutting control is achieved with two modes: - . Exposure control adjusts the bur's exposure with respect to a guard. If the surgeon encroaches on a portion of bone that is not to be cut, the robotic system retracts the bur inside the guard, disabling cutting. - Speed control regulates the signal going to the tool control unit itself and limits the speed of the drill if the target surface is approached. Alternatively, the surgeon can disable both controls and operate the robotic drill as a standard navigated surgical drill.

CORI is indicated for use in surgical procedures, in which the use of stereotactic surgery may be appropriate, and where reference to rigid anatomical bony structures can be determined. These procedures include: - · unicondylar knee replacement (UKR), - · total knee arthroplasty (TKA), - · revision knee arthroplasty, and - · total hip arthroplasty (THA).

The subject of this Traditional 510(k) is REAL INTELLIGENCE CORI (CORI), a robotic-assisted orthopedic surgical navigation and burring system. CORI uses established technologies of navigation via a passive infrared tracking camera. Based on intraoperatively-defined bone landmarks and known geometry of the surgical implant, the system aids the surgeon in establishing a bone surface model for the target surgery and planning the surgical implant location. For knee applications, CORI then aids the surgeon in executing the surgical plan by controlling the cutting engagement of the surgical bur. CORI knee application software controls the cutting engagement of the surgical bur based on its proximity to the planned target surface. The cutting control is achieved with two modes: - . Exposure control adjusts the bur's exposure with respect to a guard. If the surgeon encroaches on a portion of bone that is not to be cut, the robotic system retracts the bur inside the guard, disabling cutting. - . Speed control regulates the signal going to the tool control unit itself and limits the speed of the drill if the target surface is approached. Alternatively, the surgeon can disable both controls and operate the robotic drill as a standard navigated surgical drill.

CORI is indicated for use in surgical procedures, in which the use of stereotactic surgery may be appropriate, and where reference to rigid anatomical bony structures can be determined. These procedures include unicondylar knee replacement (UKR), total knee arthroplasty (TKA), and total hip arthroplasty (THA).

The subject of this Traditional 510(k) is REAL INTELLIGENCE CORI (CORI), a robotic-assisted orthopedic surgical navigation and burring system. CORI uses established technologies of navigation via a passive infrared tracking camera. Based on intraoperatively-defined bone landmarks and known geometry of the surgical implant, the system aids the surgeon in establishing a bone surface model for the target surgery and planning the surgical implant location. For knee applications, CORI then aids the surgeon in executing the surgical plan by controlling the cutting engagement of the surgical bur. CORI knee application software controls the cutting engagement of the surgical bur based on its proximity to the planned target surface. The cutting control is achieved with two modes: - Exposure control adjusts the bur's exposure with respect to a guard. If the surgeon encroaches on a portion of bone that is not to be cut, the robotic system retracts the bur inside the guard, disabling cutting. - Speed control regulates the signal going to the tool control unit itself and limits the speed of the drill if the target surface is approached. Alternatively, the surgeon can disable both controls and operate the robotic drill as a standard navigated surgical drill.

RI.HIP MODELER is intended for preoperative planning for primary total hip arthroplasty. RI.HIP MODELER is intended to be used as a tool to assist the surgeon in the selection and positioning of components in primary total hip arthroplasty. RI.HIP MODELER is indicated for individuals undergoing primary hip surgery.

RI.HIP MODELER is a non-invasive standalone Total Hip Arthroplasty (THA) planning software application intended to provide preoperative planning for hip implant acetabular cup rotational selection and placement. RI.HIP MODELER allows surgeons to visualize and perform analysis of digital images for assessment of spinopelvic mobility of the patient. The app is used to characterize patient conditions, manage patient performance expectations, and help surgeons determine acetabular cup placement based on spinopelvic mobility. The software provides a baseline cup orientation recommendation intended to reduce incidences of implant impingement based on patient condition and implant specifications. The surgeon is reminded to verify and adjust to the parameters based on their clinical judgment.

CORI is indicated for use in surgical procedures, in which the use of stereotactic surgery may be appropriate, and where reference to rigid anatomical bony structures can be determined. These procedures include unicondylar knee replacement (UKR), total knee arthroplasty (TKA) and total hip arthroplasty (THA). For Knee applications, CORI is indicated for use with cemented implants only.

CORI is a computer-assisted orthopedic surgical navigation and surgical burring system. CORI uses established technologies of navigation, via a passive infrared tracking camera. For robotic knee applications, CORI software can control the cutting engagement of the surgical bur based on its proximity to the planned target surface. Alternatively, the surgeon can disable both controls and operate the robotic drill as a standard navigated surgical drill. For the hip navigation application, CORI incorporates the Brainlab HIP7 software (K193307) which will be market by Smith & Nephew as RI.HIP NAVIGATION. It uses instruments and reference arrays, which are tracked by the IR camera, to determine pelvis and femur anatomical landmarks as well as implant orientation. RI.HIP NAVIGATION assists the orientation of prosthetic hip implants and enables measurement of leg length and offset when used intraoperatively in combination with CORI.

CORI is indicated for use in surgical knee procedures, in which the use of stereotactic surgery may be appropriate, and where reference to rigid anatomical bony structures can be determined. These procedures include unicondylar knee replacement (UKR) and total knee arthroplasty (TKA). CORI is indicated for use with cemented implants only.

CORI is a computer-assisted orthopedic surgical navigation and surgical burring system. CORI uses established technologies of navigation, via a passive infrared tracking camera, to aid the surgeon in establishing a bone surface model for the target surgery and in planning the surgical implant location. Based on intraoperatively-defined bone landmarks and known geometry of the surgical implant, CORI aids the surgeon in establishing a bone surface model for the target surgery and planning the surgical implant location. CORI software controls the cutting engagement of the surgical bur based on its proximity to the planned target surface. The cutting control is achieved with two modes: - Exposure control adjusts the bur's exposure with respect to a guard. If the surgeon encroaches on a portion of bone that is not to be cut, the robotic system retracts the bur inside the guard, disabling cutting. - . Speed control regulates the signal going to the drill motor controller itself and limits the speed of the drill if the target surface is approached. Alternatively, the surgeon can disable both controls and operate the robotic drill as a standard navigated surgical drill.