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Materialise Personalized Guides for Craniomaxillofacial Surgery are intended to guide the marking of bone and or guide surgical instruments in facial surgery. CMF Titanium Guides are used during bone repositioning/reconstruction surgical operations for orthognathic and reconstruction (including bone harvesting) indications. CMF Titanium Guides are intended for children, adolescents and adults. CMF Titanium Guides are intended for single use only. CMF Titanium Guides are to be used by a physician trained in the performance of maxillofacial surgery. Materialise Personalized Models for Craniomaxillofacial Surgery are intended for visualization of the patient's anatomy, preparation of surgical interventions and fitting or adjustment of implants or other medical devices such as osteosynthesis plates or distractors, in mandibular and maxillofacial surgical procedures. CMF Plastic Models are intended for infants, children, adolescents and adults. CMF Plastic Models are intended for single use only. CMF Plastic Models are to be used by a physician trained in the performance of maxillofacial surgery.

Materialise Personalized Guides and Models for Craniomaxillofacial Surgery combines the use of 3D preoperative planning software with patient-matched guides and models to improve and simplify the performance of surgical interventions by transferring the pre-operative plan to surgery. Materialise Personalized Guides and Models for Craniomaxillofacial Surgery are used in the facial skeleton or in maxillofacial surgeries. The surgical planning is based on medical images of the patient that are segmented in order to create a 3D representation of the patient's anatomy. The surgical treatment of the patient is simulated based on instructions provided by the surgeon and the patient-matched devices are tailored to the treatment and the patient's needs. The patient-matched devices are manufactured from commercially pure Titanium, polyamide, or clear acrylic by means of additive manufacturing technologies. The patient-matched devices are provided non-sterile. Materialise Personalized Guides and Models for Craniomaxillofacial Surgery include CMF Titanium Guides and CMF Plastic Models.

Mimics Enlight CMF is intended for use as a software interface and imaging segmentation system for the transfer of medical imaging information to an output file. Mimics Enlight CMF is also intended to support the diagnostic and treatment planning process of maxillofacial procedures. For this purpose, Mimics Enlight CMF provides visualization, measurement and design tools. The Mimics Enlight CMF output file can be used for the fabrication of the output file using traditional or additive manufacturing methods. The fabricated output can be used for diagnostic purposes in the field of maxillofacial applications. Mimics Enlight CMF should be used in conjunction with other diagnostic tools and expert clinical judgement.

Mimics Enlight CMF is an image processing software for the diagnosis and treatment planning of maxillofacial procedures. Mimics Enlight CMF allows the user to import, visualize and segment medical images. Mimics Enlight CMF also allows the user to perform measurements, treatment planning and occlusal splint design. Mimics Enlight CMF allows the user to output digital 3D models of the anatomy to be used for fabrication of physical anatomical models. Mimics Enlight CMF is structured as a modular package consisting of separate workflows for the diagnosis and treatment planning of various indications within the maxillofacial field. The workflows in Mimics Enlight CMF are built on the Mimics Enlight platform. The workflows in Mimics Enlight CMF cover following steps and functionality in the diagnostic and treatment planning process of maxillofacial procedures: Digital 3D model creation - . Importing medical images in DICOM format and other formats - Viewing images and DICOM data - Selecting a region of interest using generic segmentation tools - . Verifying and editing a region of interest - . Calculating a digital 3D model and editing the model - . Creating composite models by combining medical image information and dental information using registration tools - Exporting digital 3D models for additive manufacturing (3D printing) of physical replicas (anatomical models) Planning - Indicating nerves and cephalometric landmarks - . Setting the natural head position - Planning the treatment by cutting the models and repositioning the parts - Setting the occlusion digitally or by importing an occlusion model ● - Measuring on images and digital 3D models - Simulating the soft tissue of the face after the planned treatment Design - Designing personalized digital occlusal splints using generic design and finishing tools ● User fabrication using additive manufacturing (3D printing) of physical replicas includes only fabrication of anatomical models and does not include additive manufacturing of occlusal splints.

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) - 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's 3 - Titan™ Total Shoulder System (K100448, K112438, K142413, K152047) - Titan™ Reverse Shoulder System (K130050, K161189, K173717, K181999) - Lima's - SMR™ Shoulder System (K100858) - SMRTM Reverse Shoulder System (K110598) - SMRTM Modular Glenoid (K113254) (K143256) - SMR™ 3-Pegs Glenoid (K130642) - SMR™ TT Metal Back Glenoid (K133349) - SMRTM 40mm Glenosphere (K142139) - SMRTM TT Augmented 360 Baseplate (K220792) - SMR™ TT Hybrid Glenoid (K220792) - Stryker's - ReUnion RSA Reverse Shoulder System (K183039) - Reunion TSA Total Shoulder Arthroplasty System (K183039) 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 patientspecific 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 preoperative 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', DJO's, 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 graftspace 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.

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) - INHANCETM Anatomic Shoulder System (K202716) - INHANCE™ Reverse Shoulder System (K212737) - DJO's - Reverse® Shoulder Prosthesis (K051075, K111629, K092873) - Turon® Shoulder System (K080402) - AltiVate™ Anatomic Shoulder System (K162024) - Smith & Nephew's - Titan™ Total Shoulder System (K100448, K112438, K142413, K152047) - Titan™ Reverse Shoulder System (K130050, K161189, K173717, K181999) - Lima's - SMRTM Shoulder System (K100858) - SMRTM Reverse Shoulder System (K110598) - SMRTM Modular Glenoid (K113254) (K143256) - SMR™ 3-Pegs Glenoid (K130642) - SMRTM TT Metal Back Glenoid (K133349) - SMR™ 40mm Glenosphere (K142139) - Stryker's . - ReUnion RSA Reverse Shoulder System (K183039) - Reunion TSA Total Shoulder Arthroplasty System (K183039) 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. Patient-specific glenoid guide and models will be manufactured if the surgeon requests patient-specific quides 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 TKA Guide System consists of hardware (Materialise TKA Guides and Models) and software (SurgiCase Knee Planner) components. Hardware · Pin Placement Guides The Materialise TKA Guides are intended to be used as a surgical instrument to assist in the intra-operative positioning of Total Knee Replacement components and in guiding the marking of bone before cutting. The Materialise TKA Guides must be used in conjunction with the 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® fixed bearing, Zimmer Persona® CR fixed bearing, Zimmer Persona® PS fixed bearing, 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, Lima Physica PS System, Lima Physica CR Knee System, Lima Physica KR Knee System, Omni Apex CR, Ortho Development BKS CR, Ortho Development BKS PS, Ortho Development BKS TriMax CR and Ortho Development BKS TriMax PS prostheses families only. The Materialise TKA Guides are intended for single use only. • Cut-Through Guides The Materialise TKA Guides are intended to be used as a surgical instrument to assist in the intra-operative positioning of Total Knee Replacement components and in guiding the marking of bone before cutting of the bone. The Materialise TKA Guides must be used in conjunction with the 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 prostheses families only The Materialise TKA Guides are intended for single use only. • Models The Materialise TKA Models are intended to be used as a surgical instrument to assist in the intra-operative positioning of Total Knee Replacement components. The Materialise TKA Models must be used in conjunction 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® fixed bearing, Zimmer Persona® CR fixed bearing, Zimmer Persona® PS fixed bearing, 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, Lima Physica PS System, Lima Physica CR Knee System, Lima Physica KR Knee System, Omni Apex CR, Omni Apex PS , Ortho Development BKS CR, Ortho Development BKS PS, Ortho Development BKS TriMax CR and Ortho Development BKS TriMax PS prostheses families only. The Materialise TKA Models are intended for single use only. Software The SurgiCase Knee Planner is intended to be used as a pre-surgical planner for knee orthopedic surgery. The software is used to pre-operatively plan the positioning of knee components. The SurgiCase Knee Planner allows the surgeon to visualize, measure, reconstruct, annotate and edit pre-surgical plan data. The generation of a surgery report along with a pre-surgical plan data file which is used as input data to design the Materialise Knee Guides and Models.

The Materialise TKA guide system is a medical device designed to implant total knee prosthesis components during a total knee arthroplasty surgical procedure. This can be done by generating a pre-surgical knee plan and by manufacturing a patient-specific knee guide and models to transfer the knee plan to surgery. The subject device is a system that consists of the following two functional components: - l A software component branded as SurgiCase Knee Planner. This software is a planning tool used to generate a pre-surgical TKA plan for a specific patient. - Hardware components branded as Materialise TKA Guides and Models: which are patient-specific guides and models that are based on a pre-surgical plan. This pre-surgical plan is generated using the software component. Materialise TKA Guides and Models is an instrument set containing a femur and/or tibia guide(s) and bone models (optional). Both femoral and tibial guides are designed and manufactured to fit the anatomy of a specific patient. If the surgeon requests it, a bone model of the femur and/or tibia are delivered with the Materialise TKA Guides. The Materialise TKA Guides and Models assist in the intra-operative positioning of total knee replacement components. The guides assist in guiding the marking of bone before cutting and cutting of the bone. The models serve as a visual reference for the surgeon in the operating room. The Materialise TKA Guides and Models must only be used within the intended use of the compatible components (510(k) cleared, legally marketed prosthesis).

SurgiCase Viewer is intended to be used as a software interface to assist in visualization of treatment options.

SurgiCase Viewer provides functionality to allow visualization of 3D data and to perform measurements on these 3D data, which should allow a clinician to evaluate and communicate about treatment options. SurgiCase Viewer is intended for use by people active in the medical sector. When used to review and validate treatment options, SurgiCase Viewer is intended to be used in conjunction with other diagnostic tools and expert clinical judgment. The SurgiCase Viewer can be used by a medical device/service manufacturer/provider or hospital department to visualize 3D data during the manufacturing process of the product/service to the end-user who is ordering the device/service. This allows the end-user to evaluate and provide feedback on proposals or intermediate steps in the manufacturing of the device or service. The SurgiCase Viewer is to be integrated with an online Medical Device Data System which is used to process the medical device or service and which is responsible for case management, user management, authorization, authentication, etc. The data visualized in the SurgiCase Viewer is controlled by the medical device manufacturer using the SurgiCase Viewer in its process. The Device manufacturer will create the 3D data to be visualized to the end-user and export it to one of the dedicated formats supported by the SurgiCase Viewer. Each of these formats describe the 3D data in STL format with additional meta-data on the 3D models. The SurgiCase Viewer does not alter the 3D data it imports and its functioning is independent of the specific medical indication/situation or product/service it is used for. It's the responsibility of the Medical device company using the SurgiCase Viewer to comply with the applicable medical device regulations.

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' o GLOBAL® APG+ Shoulder System (K052472), o DELTA XTEND™ Reverse Shoulder System (K120174, K062250, K183077, K203694) o GLOBAL® STEPTECH® APG Shoulder System (K092122) o Ignite Anatomic Shoulder System (K202716) (rebranded to INHANCE™ Anatomic Shoulder System)) • DJO's o Reverse® Shoulder Prosthesis (K051075, K111629, K092873), o Turon® Shoulder System (K080402) o AltiVate™ Anatomic Shoulder System (K162024) · Smith & Nephew's (Integra's)2 o Titan™ Total Shoulder System (K100448, K112438, K142413, K152047) o Titan™ Reverse Shoulder System (K130050, K161189, K173717, K181999) • Lima's o SMRTM Shoulder System (K100858), o SMRTM Reverse Shoulder System (K110598), o SMR™ Modular Glenoid (K113254) (K143256), - o SMR™ 3-Pegs Glenoid (K130642), o SMR™ TT Metal Back Glenoid (K133349), - o SMRTM 40mm Glenosphere (K142139). · Stryker's o ReUnion RSA Reverse Shoulder System (K183039) o Reunion TSA Total Shoulder Arthroplasty System (K183039). 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 serves as a visual reference for the surgeon in the OR. The Materialise Shoulder Guide and Models must only be used within the intended use of the compatible components.

Hardware · Guides The Materialise PKA Guides are intended to be used as a surgical instrument to assist in the intra-operative positioning of Partial Knee Replacement components and in guiding the marking of bone before cutting of the bone. The Materialise PKA Guides must be used in conjunction with the compatible prostheses families only: ZUK UNI. JOURNEY™ UNI, JOURNEY II UNI, JZ (Hybrid) UNI knee systems, Vanguard™ M Unicompartmental Knee System, Oxford® Partial Knee System and Persona® Partial Knee System. The Zimmer Biomet Patient Specific Instruments are compatible for use with the Oxford® Partial Knee System as approved in P010014. The Materialise PKA Guides are intended for single use only. • Models The Materialise PKA Models are intended to be used as a surgical instrument to assist in the intra-operative positioning of Partial Knee Replacement components. The Materialise PKA Models must be used in conjunction with the compatible prostheses families only: ZUK UNI, JOURNEY™ UNI, JOURNEY II UNI, JZ (Hybrid) UNI knee systems, Vanguard™ M Unicompartmental Knee System, Oxford® Partial Knee System and Persona® Partial Knee System. The Zimmer Biomet Patient Specific Instruments are compatible for use with the Oxford® Partial Knee System as approved in P010014. The Materialise PKA Models are intended for single use only. Software The SurgiCase Knee Planner is intended to be used as a pre-surgical planner for knee orthopedic surgery. The software is used to pre-operatively plan the positioning of knee components. The SurgiCase Knee Planner allows the surgeon to visualize, measure, reconstruct, annotate and edit pre-surgical plan data. The generation of a surgery report along with a pre-surgical plan data file which is used as input data to design the Materialise Knee Guides and Models.

The Materialise PKA guide system is a medical device designed to implant a partial knee prosthesis during partial knee arthroplasty surgical procedures. The device is a system that consists of the following two functional components: - . A software component, branded as SurgiCase Knee Planner. This software is a planning tool used to generate a pre-surgical PKA plan for a specific patient. - . A hardware component, branded as Materialise PKA Guides and Models, which are patientspecific guides and models that are based on a pre-surgical plan. This pre-surgical plan is generated using the software component. Materialise PKA Guides and Models is an instrument set containing a femur and/or tibia guide (s) and bone models (optional). Both femoral and tibial guides are designed and manufactured to fit the anatomy of a specific patient. If the surgeon requests it, a bone model of the femur and tibia is delivered with the Materialise PKA Guides. The Materialise PKA Guides and Models assist in the intra-operative positioning of partial knee replacement components. The guides assist in guiding the marking of bone before cutting and cutting of the bone. The models serve as a visual reference for the surgeon in the operating room. The Materialise PKA Guides and Models must only be used within the intended use of the compatible components (510(k) cleared, legally marketed prosthesis).

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' - o GLOBAL® APG+ Shoulder System (K052472), - o DELTA XTEND™ Reverse Shoulder System (K120174, K062250, K183077) - o GLOBAL® STEPTECH® APG Shoulder System (K092122). • DJO's - o Reverse® Shoulder Prosthesis (K051075, K111629, K092873). - o Turon® Shoulder System (K080402) - o AltiVate™ Anatomic Shoulder System (K162024) - · Integra's o Titan™ Total Shoulder System (K100448, K112438, K142413, K152047) - o Titan™ Reverse Shoulder System (K130050, K161189, K173717, K181999) - Lima's - o SMRTM Shoulder System (K100858), - o SMRTM Reverse Shoulder System (K110598), - o SMRTM Modular Glenoid (K113254) (K143256), - o SMR™ 3-Pegs Glenoid (K130642), - o SMR™ TT Metal Back Glenoid (K133349), - o SMRTM 40mm Glenosphere (K142139). · Stryker's - o ReUnion RSA Reverse Shoulder System (K183039) - o Reunion TSA Total Shoulder Arthroplasty System (K183039). 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 serves as a visual reference for the surgeon in the OR. The Materialise Shoulder Guide and Models must only be used within the intended use of the compatible components.