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Hardware: The Materialise Shoulder Guide and Models are intended to be used as a surgical instrument to assist in the intraoperative positioning of glenoid components used with total and reverse shoulder arthroplasty by referencing anatomic landmarks of the shoulder that are identifiable on preoperative CT-imaging scans. The Materialise Shoulder Guide and Models are single use only. The Materialise Shoulder Guide and Models can be used in conjunction with the following total and reverse shoulder implants systems and their respective compatible components: - · DePuy Synthes' - GLOBAL® APG+ Shoulder System (K052472) - DELTA XTEND™ Reverse Shoulder System (K120174, K062250, K183077, K203694) - GLOBAL® STEPTECH® APG Shoulder System (K092122) - INHANCE™ Anatomic Shoulder System (K202716)1 - INHANCE™ Reverse Shoulder System (K212737) - INHANCE™ Hybrid Anatomic Glenoid Implant (K212933) - INHANCE™ Reverse Glenoid Peripheral Posts (K221467) - INHANCE Convertible Glenoid (K230831) - · Enovis'2 (DJO) - Reverse® Shoulder Prosthesis (K051075, K111629, K092873) - Turon® Shoulder System (K080402) - AltiVate™ Anatomic Shoulder System (K162024) - AltiVate™ Anatomic Augmented Glenoid (K213387, K222592) - AltiVate™ Reverse Glenoid (K233481) - · Smith+Nephew's3 - Titan™ Total Shoulder System (K100448, K112438, K142413, K152047) - Titan™ Reverse Shoulder System (K130050, K161189, K173717, K181999) - AETOS Total Shoulder System (K220847, K230572) - AETOS Reverse Shoulder System (K220847, K230572) - · Lima's - SMR™ Shoulder System (K100858) - SMR™ Reverse Shoulder System (K110598) - SMR™ Modular Glenoid (K113254) (K143256) - SMR™ 3-Pegs Glenoid (K130642) - SMR™ TT Metal Back Glenoid (K133349) - SMR TM 40mm Glenosphere (K142139) - SMR™ TT Augmented 360 Baseplate (K220792) - SMR™ TT Hybrid Glenoid (K220792) - PRIMA TT Glenoid (K222427) Software: SurgiCase Shoulder Planner is intended to be used as a pre-surgical planner for simulation of surgical interventions for shoulder orthopedic surgery. The software is used to assist in the positioning of shoulder components. SurgiCase Shoulder Planner allows the surgeon to visualize, measure, reconstruct, annotate and edit pre-surgical plan data. The software leads to the generation of a surgery report along with a pre-surgical plan data file which can be used as input data to design the Materialise Shoulder Guide and Models.

Materialise Shoulder System™ is a patient-specific medical device that is designed to be used to assist the surgeon in the placement of shoulder components during total anatomic and reverse shoulder replacement surgery. This can be done by generating a pre-surgical shoulder plan and, if requested by the surgeon, by manufacturing a patient-specific glenoid guide and models to transfer the glenoid plan to surgery. The device is a system composed of the following: - a software component, branded as SurgiCase Shoulder Planner. This software is a planning tool used . to generate a pre-surgical plan for a specific patient. - Materialise Shoulder Guide and Models, which are a patient-specific quide and models that are based ● on a pre-surgical plan. This pre-surgical plan is generated using the software component. Patientspecific glenoid guide and models will be manufactured if the surgeon requests patient-specific guides to transfer the glenoid plan to surgery. The Materialise Shoulder Guide is designed and manufactured to fit the anatomy of a specific patient. A bone model of the scapula is delivered with the Materialise Shoulder Guide. A graft model can be delivered with the Materialise Shoulder Guide. The graft model visualizes the graft-space between implant and bone, based on the pre-operative planning of the surgeon. The graft model serves as a visual reference for the surgeon in the OR.

Hardware: The Materialise Shoulder Guide and Models are intended to be used as a surgical instrument to assist in the intraoperative positioning of glenoid components used with total and reverse shoulder arthroplasty by referencing anatomic landmarks of the shoulder that are identifiable on preoperative CT-imaging scans. The Materialise Shoulder Guide and Models are single use only. The Materialise Shoulder Guide and Models can be used in conjunction with the following total and reverse shoulder implants systems and their respective compatible components: - DePuy Synthes' - GLOBAL® APG+ Shoulder System (K052472) - DELTA XTEND™ Reverse Shoulder System (K120174, K062250, K183077, K203694) - GLOBAL® STEPTECH® APG Shoulder System (K092122) - INHANCE™ Anatomic Shoulder System (K202716)1 - INHANCE™ Reverse Shoulder System (K212737) - INHANCE Hybrid Anatomic Glenoid Implant (K212933) - INHANCE Reverse Glenoid Peripheral Posts (K221467) - Enovis'2 (DJO) - Reverse® Shoulder Prosthesis (K051075, K111629, K092873) - Turon® Shoulder System (K080402) - AltiVate™ Anatomic Shoulder System (K162024) - AltiVate™ Anatomic Augmented Glenoid (K213387) - Smith+Nephew's3 - Titan™ Total Shoulder System (K100448, K112438, K142413, K152047) - Titan™ Reverse Shoulder System (K130050, K161189, K173717, K181999) - AETOS Total Shoulder System (K220847, K230572) - AETOS Reverse Shoulder System (K220847, K230572) - Lima's - SMR™ Shoulder System (K100858) - SMR™ Reverse Shoulder System (K110598) - SMR™ Modular Glenoid (K113254) (K143256) - SMR™ 3-Pegs Glenoid (K130642) - SMR™ TT Metal Back Glenoid (K133349) - SMR™ 40mm Glenosphere (K142139) - SMR™ TT Augmented 360 Baseplate (K220792) - SMR™ TT Hybrid Glenoid (K220792) - PRIMA TT Glenoid (K222427) Software: SurgiCase Shoulder Planner is intended to be used as a pre-surgical planner for simulation of surgical interventions for shoulder orthopedic surgery. The software is used to assist in the positioning of shoulder components. SurgiCase Shoulder Planner allows the surgeon to visualize, measure, reconstruct, annotate and edit pre-surgical plan data. The software leads to the generation of a surgery report along with a pre-surgical plan data file which can be used as input data to design the Materialise Shoulder Guide and Models.

Materialise Shoulder System™ is a patient-specific medical device that is designed to be used to assist the surgeon in the placement of shoulder components during total anatomic and reverse shoulder replacement surgery. This can be done by generating a pre-surgical shoulder plan and, if requested by the surgeon, by manufacturing a patient-specific glenoid guide and models to transfer the glenoid plan to surgery. The device is a system composed of the following: - a software component, branded as SurgiCase Shoulder Planner. This software is a planning tool used to generate a pre-surgical plan for a specific patient. - Materialise Shoulder Guide and Models, which are a patient-specific guide and models that are based on a pre-surgical plan. This pre-surgical plan is generated using the software component. Patient-specific glenoid guide and models will be manufactured if the surgeon requests patient-specific guides to transfer the glenoid plan to surgery. The Materialise Shoulder Guide is designed and manufactured to fit the anatomy of a specific patient. A bone model of the scapula is delivered with the Materialise Shoulder Guide. A graft model can be delivered with the Materialise Shoulder Guide. The graft model visualizes the graft-space between implant and bone, based on the pre-operative planning of the surgeon. The graft model serves as a visual reference for the surgeon in the OR.

Mimics Cardiac Planner is intended to be used as a pre-procedural planning software to screen and plan structural heart and vascular procedures based on DICOM compliant medical images. Mimics Cardiac Planner allows the clinician to visualize, measure, annotate and edit pre-procedural plan data. The software can be used to evaluate the sizing, positioning and delivery pathway of structural heart and vascular devices. Mimics Cardiac Planner should be used in conjunction with other diagnostic tools and expert clinical judgement.

The Mimics Cardiac Planner is an online planning software, which allows the clinician to review and adjust a plan for a structural heart or vascular procedures based on DICOM images, 3D models and landmarks. The software guides the clinician through different steps of the cardio-vascular workflow, where the relevant information, like 3D models of anatomy and devices, images, landmarks and measurements are presented. The software enables the clinician to review the anatomy and relevant workflow specific predefined set of measurements, evaluate the device size and position, assess the delivery pathway and prepare the fluoroscopy angles for the procedure. The software provides the tools to adjust all predefined measurements, and to perform custom measurements. The software is integrated with a Medical Device Data System, which is responsible for the case management and user management.

Hardware: The Materialise Shoulder Guide and Models are intended to be used as a surgical instrument to assist in the intraoperative positioning of glenoid components used with total and reverse shoulder arthroplasty by referencing anatomic landmarks of the shoulder that are identifiable on preoperative CT-imaging scans. The Materialise Shoulder Guide and Models are single use only. The Materialise Shoulder Guide and Models can be used in conjunction with the following total and reverse shoulder implants systems and their respective compatible components: DePuy Synthes', Enovis' (DJO), Smith+Nephew's, Lima's, Stryker's. Software: SurgiCase Shoulder Planner is intended to be used as a pre-surgical planner for simulation of surgical interventions for shoulder orthopedic surgery. The software is used to assist in the positioning of shoulder components. SurgiCase Shoulder Planner allows the surgeon to visualize, measure, reconstruct, annotate and edit pre-surgical plan data. The software leads to the generation of a surgery report along with a pre-surgical plan data file which can be used as input data to design the Materialise Shoulder Guide and Models.

Materialise Shoulder System™ is a patient-specific medical device that is designed to be used to assist the surgeon in the placement of shoulder components during total anatomic and reverse shoulder replacement surgery. This can be done by generating a pre-surgical shoulder plan and, if requested by the surgeon, by manufacturing a patient-specific glenoid guide and models to transfer the glenoid plan to surgery. The device is a system composed of the following: a software component, branded as SurgiCase Shoulder Planner. This software is a planning tool used to generate a pre-surgical plan for a specific patient. Materialise Shoulder Guide and Models, which are a patient-specific guide and models that are based on a pre-surgical plan. This pre-surgical plan is generated using the software component. Patient-specific glenoid guide and models will be manufactured if the surgeon requests patient-specific guides to transfer the glenoid plan to surgery. The Materialise Shoulder Guide is designed and manufactured to fit the anatomy of a specific patient. A bone model of the scapula is delivered with the Materialise Shoulder Guide. A graft model can be delivered with the Materialise Shoulder Guide. The graft model visualizes the graft-space between implant and bone, based on the pre-operative planning of the surgeon. The graft model serves as a visual reference for the surgeon in the OR.

Materialise Mimics Enlight is intended for use as a software interface and image segmentation system for the transfer of DICOM imaging information from a medical scanner to an output file. It is also intended as a software to aid interpreting DICOM compliant images for structural heart and vascular treatment options. For this purpose. Materialise Mimics Enlight provides additional visualisation and measurement tools to enable the user to screen and plan the procedure. The Materialise Mimics Enlight output file can be used for the fabrication of physical replicas of the using traditional additive manufacturing methods. The physical replica can be used for diagnostic purposes in the field of cardiovascular applications. Materialise Mimics Enlight should be used in conjunction with other diagnostic tools and expert clinical judgement.

Materialise Mimics Enlight for structural heart and vascular planning is a software interface that is organized in a workflow approach. High level, each workflow in the field of structural heart and vascular will follow the same kind of structure of 4 steps which will enable the user to plan the procedure: - 1. Analyse anatomy - 2. Plan device - 3. Plan delivery - 4. Output To perform these steps the software provides different methods and tools to visualize and measure based on the medical images. The user is a medical professional, like cardiologists or clinical specialists. To start the workflow DICOM compliant medical images will need to be imported. The software will read the images and convert them into a project file. The user can now start the workflow and follow the steps visualized in the software. The base of the workflow is to create a 3D reconstruction of the anatomy based on the medical images to use this further together with the 2D medical images in the workflow to plan the procedure.

The Materialise TKA Guide System is intended to be used as a surgical instrument to assist in the positioning of total knee replacement components intra-operatively and in guiding the marking of bone before cutting provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans. The Materialise TKA Guide System is to be used with Zimmer NexGen CR-Flex fixed bearing, Zimmer NexGen CR fixed bearing, Zimmer NexGen LPS-Flex fixed bearing, Zimmer NexGen LPS fixed bearing, Zimmer Gender Solutions Natural - Knee Flex fixed bearing, Zimmer Persona™ CR fixed bearing, Zimmer Persona™ PS fixed bearing, Zimmer Persona™ Trabecular Metal™, Vanguard® Complete Knee System, Vanguard® SSK 360, Vanguard® SSK Revision Knee System, Regenerex® Primary Tibial System, Offset & Microplasty Tibial Systems, Maxim® Complete Knee System, Ascent™ Total Knee System, and AGC® Complete Knee system, and Consensus Knee System prostheses families only. The Materialise TKA Guides are intended for single use only.

Materialise TKA Guides are patient-specific medical devices that are designed to implant the following knee prostheses: Zimmer NexGen CR-Flex fixed bearing, Zimmer NexGen CR fixed bearing, Zimmer NexGen LPS-Flex fixed bearing, Zimmer NexGen LPS fixed bearing, Zimmer Gender Solutions Natural - Knee Flex fixed bearing, Zimmer Persona™ CR fixed bearing, Zimmer Persona™ PS fixed bearing, Zimmer Persona ™ Trabecular Metal ™, Vanguard® Complete Knee System, Vanguard® SSK 360, Vanguard® SSK Revision Knee System, Regenerex® Primary Tibial System, Offset & Microplasty Tibial Systems, Maxim® Complete Knee System, Ascent™ Total Knee System, and AGC® Complete Knee system, and Consensus Knee System. The Materialise TKA Guides must only be used in conjunction with the implants listed above. Consult the prosthesis labeling and instructions for use for specific patient indications, associated risks, information for use, warnings and precautions. Materialise TKA Guides is an instrument set containing a femur and/or tibia template(s).

Total Knee Replacement The Zimmer® Patient Specific Instruments System is intended to be used as a surgical instrument to assist in the positioning of Total Knee Replacement components intraoperatively and in guiding the marking of bone before cutting provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans. The Zimmer® Patient Specific Instruments System is to be used with Zimmer NexGen CR-Flex fixed bearing, Zimmer NexGen CR fixed bearing, Zimmer NexGen LPS-Flex fixed bearing, Zimmer NexGen LPS fixed bearing, Zimmer Gender Solutions Natural - Knee Flex fixed bearing, Zimmer Persona™ CR fixed bearing, Zimmer Persono™ PS fixed bearing and Zimmer Persona™ Trabecular Metal™ prostheses families only. Unicompartmental Knee Replacement The Zimmer® Patient Specific Instruments System is intended to be used as a surgical instrument to assist in the positioning of Unicompartmental Knee Replacement components intra-operatively and in guiding the marking of bone before cutting and to guide cutting of the bone provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans. The Zimmer® Patient Specific Instruments System is to be used with Zimmer Unicompartmental High Flex Knee System prostheses families only. The Zimmer® Patient Specific Instruments are intended for single use only.

The subject device Zimmer® Patient Specific Instruments System 6.0 is a modification to the predicate device Zimmer® Patient Specific Instruments System 4.0 (K113829) to accommodate the new compatible implant system Zimmer® Persona'''' components, cleared via 510(k)s K113369, K122745 and K121771. A similar change was done for Zimmer® Patient Specific Instruments System 5.0 (K121640) where the Zimmer® Personal™ components, cleared via 510(k) K113369, were added to MRI image based system. Zimmer® Patient Specific Instruments System 6.0 is designed to assist a surgeon in the placement of total knee replacement components for Zimmer® Persona'" components. The system consists of a software device, branded as Zimmer® Patient Specific Instruments Planner (ZPSIP) and a hardware component, branded as Zimmer® Patient Specific Instruments (ZPSI).

The SurgiCase Orthopaedics system is intended to be used as a surgical instrument to assist in pre-operative planning and/or in guiding the marking of bone and/or guide surgical instruments in non-acute, non-joint replacing osteotomies for upper extremity orthopedic surgical procedures and osteotomies around the knee. The system is to be used for adult patients. SurgiCase Guides are intended for single use only.

The SurgiCase Orthopaedics system is intended to be used as a surgical instrument to transfer a pre-surgical plan to the surgery with osteotomies on upper extremity orthopedic procedures anound the knee. The SurgiCase Orthopaedics system is components: SurgiCase Connect (software) and SurgiCase Guides (hardware). SurgiCase Connect is a medical device for Materialise and a surgeon for pre-surgical simulation of surgical treatment options. This includes transfering, visualizing, measuring, annotating and editing medical data. The SurgiCase Guides are patient specific templates that are designed and manufactured based on a pre-surgical software plan for a specific patient. In surgery these guides are used to assist a surgeon in guiding the marking of bone and/or guiding surgical instruments to cut and drill according to the pre-surgical plan. All guides are individually designed and manufactured for each patient using a design and manufacturing process with strict procedures and work instructions to guarantee guides that consistently perform in a safe and effective way. Part of this process is a scientific Stability Model which measures the sensitivity of a guide to movement during surgery. The use of this Stability Model ensures a stable position on the patient's anatomy for accurate guiding of surgical instruments. The Stability Model is anatomy independent, thus it can be applied to any bony structure in upper extremity surgical procedures and osteotomies around the knee.

Pin Placement Guides: Signature Personalized Patient Care System is intended to be used as a surgical instrument to assist in the positioning of total knee replacement components intra-operatively and in guiding the marking of bone before cutting provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans. The Signature Personalized Patient Care System can be used with the following Biomet® Knee Systems and their respective components: Vanguard™ Complete Knee System, Vanguard™ SSK 360, Vanguard™ SSK Revision Knee System, Regenerex™ Primary Tibial System, Offset & . Microplasty™ Tibial Systems, Maxim™ Complete Knee System, Ascent™ Total Knee System, AGC™ Complete Knee system and Vanguard™ XP Knee system. Cut-Through Guides: Signature Personalized Patient Care System is intended to be used as a surgical instrument to assist in the positioning of total and partial knee replacement components intra-operatively and in guiding the marking of bone before cutting and to guide cutting, provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans. The Signature Personalized Patient Care System can be used with the following Biomet® Knee Systems and their respective components: Vanguard™ Complete Knee System, Vanguard M1™ Unicompartmental Knee System, Vanguard™ SSK 360, Vanguard™ SSK Revision Knee System, Regenerex™ Primary Tibial System, Offset & Microplasty™ Tibial Systems, Maxim™ Complete Knee System, Ascent™ Total Knee System, AGC™ Complete Knee system and Vanguard™ XP Knee system. The Signature Personalized Patient Care System is compatible for use with the Oxford® Partial Knee System as approved in P010014/S31. The Signature guides are intended for single use only.

The Signature Personalized Patient Care System consists of a software component, Signature Planner and a hardware component, Signature guides and is designed to assist the surgeon in the placement of Biomet total knee replacement components. The Signature guides are patient specific devices that are based on a pre-operative plan which is generated using the Signature Planner software. The Signature guides are produced based on the pre-operative plan and are manufactured to fit a specific patient. The Signature Planner software functions essentially the same as in K102795 and K110415, but is adapted to allow the use of Biomet Vanguard™ XP Knee system (K122160) for total knee arthroplasty procedures. The subject guides are intended for the total knee arthroplasty procedures and represent a combination of design and functionality of those in K102795 and K110415. The Vanguard XP-CR tibial tray will utilize the guides cleared in K102795/K110415 as they have the same profile/bone interface as the predicates. The Vanguard XP-XP tibia guide have similar vertical cut slots as partial tibia guide in K110415. The vertical cut-through slots allow for preliminary cuts of the bone, before final cuts are made and the implant is placed.