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Archer^R PSI System is indicated as an orthopedic instrument to assist the physician in the intraoperative positioning of total shoulder replacement components and in guiding the drill and the cut of the bone. Archer^R PSI System must only be used conjointly with Archer™ CSR Total Shoulder (K152825, K173812, K181287, K182500, K191811), Catalyst EA Convertible Stemmed Shoulder (K222317) and Archer™ R1 Reverse (K202611, K211991, K213349, K223655, K232583) components in the context of primary total shoulder replacement and following a delto-pectoral approach only. Archer^R PSI System is manufactured from a pre-operative planning validated by the surgeon in the 'Archer™ 3D Targeting' platform (K213779). Archer^R PSI System is indicated for patient population fulfilling the Archer™ CSR Total Shoulder, Catalyst EA Convertible Stemmed Shoulder and Archer™ R1 Reverse indications and for which CT images are available with identifiable placement anatomical landmarks and compliant with imaging protocol provided by Archer 3D Targeting. The device is intended for single use only. The device is intended for adult patients. The device has to be used by a physician trained in the performance of surgery.

The "Archer PSI System" device is a patient-matched additively manufactured single use surgical instrument (PSI). Archer PSI System is an instrument set containing a glenoid guide and its bone model and/or a humeral guide and its bone model. This patient-specific medical device is designed to fit the patient's anatomy to transfer a patient-specific pre-operative plan to the operating room. It is intended for surgical interventions in orthopaedic procedures for total shoulder arthroplasty. The Archer PSI system instruments are designed from a draft treatment plan available via the Archer™ 3D Targeting' platform. Based on computed tomography (CT) of the shoulder anatomy, 3D CAD models of the bones and positioning and sizing of the glenoid and humeral components are submitted for evaluation to the surgeon. Upon the surgeon's approval, the guides and bone models are designed based on the validated planning and are manufactured using additive manufacturing.

The CORE Shoulder System is a handheld surgical instrument with computer-assisted instrument tracking and is intended to assist the surgeon with placement of the K-wire (central guide pin) used in the preparation of the glenoid and the positioning of the glenoid component during primary Anatomic or Reverse total shoulder arthroplasty. The CORE Shoulder System tracks the live position of the instruments relative to an untracked virtual anatomical model. It does not track the patient anatomy. The CORE Shoulder System is designed for use with the following LINK Implant systems: - · LINK Embrace Shoulder System Reverse Configuration (K200368, K212992, K231445) - · LINK Embrace Shoulder System Anatomic Configuration (K210899)

The CORE Shoulder System is a handheld surgical instrument with computer-assisted instrument tracking and is intended to assist the surgeon with placement of the K-wire (central guide pin) used in the preparation of the glenoid and the positioning of the glenoid component during primary Anatomic or Reverse total shoulder arthroplasty. CORE Shoulder assists the surgeon in placing the K-wire according to the preoperatively planned location. The CORE Shoulder System tracks the live position of the instruments relative to an untracked virtual anatomical model. It does not track the patient anatomy. It allows the surgeon to visually compare the planned and placed position/trajectory of the guide pin (K-wire) by referencing a virtual 3D model of the pre-operative plan and the measured location of the K-wire. The system components include the Workstation (tablet, AC adapter, stand), the handheld COREmote (single-use Power Unit and reusable Sensor Unit), and reusable stainless-steel probes of different sizes.

Software: The Precision AI Planning Software is intended to be used as a pre-surgical planner for simulation of surgical interventions for shoulder joint arthroplasty. The software is used to assist in the positioning of shoulder components by creating a 3D bone construct of the joint and allows the surgeon to visualize, measure, reconstruct, annotate and edit presurgical 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 Precision AI Shoulder Guide and Biomodels. Hardware: The Precision AI Planning System Guides and Biomodels are intended to be used as patient-specific surgical instruments to assist in the intraoperative positioning of shoulder implant components used with total and reverse shoulder arthroplasty by referencing anatomic landmarks of the shoulder that are identifiable on preoperative CT-imaging scans. The Glenoid Guide is used to place the k-wire and the Humeral Guide is used to place humeral pins for humeral head resection. The Precision AI Guides and Biomodels are indicated for single use only. The Precision AI Surgical Planning System is indicated for use on adult patients that have been consented for shoulder joint arthroplasty. Both humeral and glenoid guides are suitable for a delto-pectoral approach only. The Precision AI Surgical Planning System is indicated for total and reverse shoulder arthroplasty using the following implant systems and their compatible components: Enovis and Lima.

The Precision AI Surgical Planning 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 guides and models to transfer the plan to surgery. The subject device is a system composed of the following: The Precision AI Surgical Planning System Software will create a 3D construct/render of the patient's shoulder joint for the surgeon to plan the operatively then create a physical Patient Specific Instrument (or Guide), using 3D printing by selective laser sintering. The patient's CT scan images are the design input for this to be created and are auto segmented via a locked, or static, artificial intelligence algorithm. The surgeon can visualise the deformity of the diseased joint, on this 3D render and CT scan images, and determine the inherent deformity of the joint. They are then able to virtually place the artificial implants in an optimal position to correct the measured deformity for that specific patient. The Precision AI Guides, 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 guide and models will be manufactured if the surgeon requests patient-specific guides to transfer the plan to surgery.

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.

VIP Web Portal: The VIP Web Portal is intended for use as a software interface and for the transfer of imaging information from a medical scanner such as a CT scanner. It is also intended as software for displaying/editing implant placement and surgical treatment options that were generated in the OrthoVis desktop software by trained Arthrex technicians. The VIP Web Portal is intended for use with the VIP glenoid instrumentation and with the OrthoVis preoperative plan. It is indicated for use with the following implant lines: Univers™ Apex total shoulder systems, keeled or pegged glenoid components, the Univers VaultLock® glenoid component, as well as the Univers Revers™ baseplate component (Universal Glenoid), Univers Revers™ modular glenoid system (MGS) baseplates, and Arthrex humeral implants compatible with these implant lines. OrthoVis Preoperative Plan: The OrthoVis Preoperative Plan is a preoperative plan created via the OrthoVis software that facilitates accurate preoperative planning of glenoid and humeral components in total shoulder replacement, and intraoperative placement of the glenoid component in total shoulder replacement. The VIP Glenoid Targeter is indicated for use with the Univers™ II and Univers™ Apex total shoulder systems, keeled or pegged glenoid components, the Univers VaultLock® glenoid component, as well as the Univers Revers™ baseplate component (Universal Glenoid) and Univers Revers™ modular glenoid system (MGS) baseplates. The VIP Glenoid Reamer is indicated for use with the Univers VaultLock® glenoid component and the Univers Revers™ modular glenoid system (MGS) baseplates. The indications for use of the Arthrex shoulder systems with which the OrthoVis Preoperative Plan is intended to be used are the same as those described in the labeling for these shoulder systems.

Arthrex Virtual Implant Positioning (VIP) System software comprises VIP Web Portal software and OrthoVis Preoperative Plan software. The VIP Web Portal is web-based software intended for use to facilitate the upload of medical images, preoperative planning, and plan approval of placement and orientation of total shoulder replacement components. Each surgeon user's uploaded images are grouped into cases and associated with that user's profile. Uploaded images can be downloaded from the VIP Web Portal by Arthrex technicians and used to create preoperative plans in OrthoVis (a desktop application). Once created, the preoperative plans are uploaded back to the VIP Web Portal, where the surgeon user is then able to login and review the preoperative plan. Subsequently, the surgeon user may either approve the plan, or modify the type, size, location and/or orientation of the joint replacement component and then approve the plan. The approved plan is then made available for download by the surgeon user.

Software The Precision Al Planning Software is intended to be used as a pre-surgical planner for simulation of surgical interventions for shoulder ioint arthroplasty. The software is used to assist in the positioning of shoulder components by creating a 3D bone construct of the joint and 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 Precision Al Shoulder Guide and Biomodels. Hardware The Precision Al Planning System Guides and Biomodels are intended to be used as patientspecific surgical instruments to assist in the intraoperative positioning of shoulder implant components used with total and reverse shoulder arthroplasty by referencing anatomic landmarks of the shoulder that are identifiable on preoperative CT-imaging scans. The Glenoid Guide is used to place the k-wire and the Humeral Guide is used to place humeral pins for humeral head resection. The Precision Al Guides and Biomodels are indicated for single use only. The Precision AI Surgical Planning System is indicated for use on adult patients that have been consented for shoulder joint arthroplasty. Both humeral and glenoid guides are suitable for a deltopectoral approach only. The Precision Al Surgical Planning System is indicated for total and reverse shoulder arthroplasty using the following Enovis implant systems and their compatible components: - AltiVate Anatomic Shoulder System (K162024) - AltiVate Anatomic Augmented Glenoid (K213387) - Turon Shoulder System (K111629) - Reverse Shoulder Prosthesis (K051075, K092873, K111629)

Precision Al Surgical Planning System (PAI-SPS) 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 guide and models to transfer the surgical plan to surgery. The device is a system composed of the following: - a software component, Precision Al Surgical Planning Software which will create a 3D construct of the patient's joint for the surgeon to plan the operatively. The surgeon will be able to visualise the movement of the diseased joint and determine mechanical failings. They will then be able to place the virtual shoulder replacement in different positions and decide which position gives the patient the best result. Once the surgeon has decided on the best position, the software will generate a CAD file for a Patient Specific Guide. - Precision Al Surgical Guides, which are patient-specific guides and models will be manufactured if the surgeon requests patient-specific guides to transfer the surgical plan to surgery. Once the CAD model is generated from the planning software, the model is sent to a 3D printer which will then print the guide out of a biocompatible medical grade Nylon material for sintering (Polyamide-12) which has an established usage for similar application. The specific design of the guide will be customised to the individual patient as well as depending on the particular anatomy it will be applied to. Precision Al Patient Specific Guides are intended for single use only.

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.

The Signature™ ONE System is indicated, based on patient-specific radiological images with identifiable placement anatomical landmarks, to assist in pre-operative planning and/or intra-operative guiding of surgical instruments for shoulder replacement surgical procedures on patients not precluded from being radiologically scanned. The Signature™ ONE System is designed for use on a skeletally mature patient population. The targeted population has the same characteristics as the population that is suitable for the implants compatible with the Signature™ ONE System. The Signature™ ONE System is to be used with the glenoid components of the following shoulder implant systems in accordance with their indications: Zimmer® Trabecular Metal Reverse Plus® Shoulder. Comprehensive® Total Shoulder System, Comprehensive® Reverse Shoulder System, Comprehensive® Reverse Augmented Baseplates and Alliance® Glenoid System. The Signature™ ONE System pre-operative planning is also compatible with the humeral components of the following shoulder implant systems in accordance with their indications: Comprehensive® Total Shoulder System, Comprehensive® Reverse Shoulder System, and Identity™ Shoulder System. The Signature™ ONE System Guides and bone models are intended for single use only.

The Signature™ ONE System is developed to assist in preoperative planning (using the Signature™ ONE Planner) and to accurately transfer a pre-operative plan to orthopedic surgical procedures (using the Signature™ ONE Guides and bone model) if desired in skeletally mature individuals for Total Shoulder Arthroplasty. Both anatomic and reverse (TSA and RSA respectively) approaches are supported. The Signature ONE Guides and Bone Models are designed and manufactured of polyamide (nylon) using additive manufacturing selective laser sintering (SLS), based on the approved/finalized pre-surgical plan and shipped prior to surgery. The guides and bone models are provided nonsterile and sterilized at the hospital. They are used intraoperatively to assist the surgeon in reproducing the plan on the scapula. The Signature ONE System surgical technique remains close to the conventional shoulder arthroplasty workflow. The Signature™ ONE System uses a Non-Device Medical Device Data System (MDDS) called the Zimmer Biomet Portal for the interaction with external users (i.e. imaging technician and the surgeon). The internal users (i.e. the Zimmer Biomet operators) use manufacturing software applications to prepare the patient cases for the surgeon. The purpose of this submission is to introduce new hardware kits for the existing compatible Comprehensive Reverse Augment implants and to include the addition of pre-operative planning of humeral components. A Rotational Guide component will be available as part of these two kits. Modifications have been made to the software applications to accommodate the new guide ordering option. The overall manufacturing process, materials, sterilization methods, have not changed from the previous primary predicate and principal of operation remains similar.

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.

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.