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The Glenoid Intelligent Reusable Instrument System ("Glenoid IRIS") is a patient specific manual instrument system intended to facilitate preoperative planning and intraoperative placement of the central glenoid guide pin used in the preparation of the glenoid in total shoulder systems that utilize a central guide pin for preparing the glenoid to receive the glenoid implant. The Arthrex Glenoid IRIS is indicated for use with the Arthrex Univers II and Arthrex Univers Apex, Keeled or Pegged Glenoid components, the Vault Lock Glenoid Component, as well as the Univers Revers Baseplate component. The indications for use of the Arthrex shoulder systems with which the Arthex Glenoid IRIS is intended to be used are the same as those described in the labeling for these shoulder systems. The Arthrex OrthoVis Preoperative Plan is a preoperative plan created via the OrthoVis software that facilitates accurate preoperative planning and intraoperative placement of the glenoid component in total shoulder replacement. The Arthrex Glenoid IRIS is indicated for use with the Arthrex Univers II and Arthrex Univers Apex, Keeled or Pegged Glenoid components, the Vault Lock Glenoid Component, as well as the Univers Revers Baseplate component. The indications for use of the Arthrex shoulder systems with which the Arthex OrthoVis Preoperative Plan is intended to be used are the same as those described in the labeling for these shoulder systems. The Arthrex 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 COS technicians. The Arthrex VIP Web Portal is intended for use with the Arthrex Glenoid Intelligent Reusable Instrument System (Arthrex Glenoid IRIS) and with the Arthrex OrthoVis Preoperative Plan. It is indicated for use with the following glenoid implant lines: Arthrex Univers II and Arthrex Univers Apex, Keeled or Pegged Glenoid components, the Vault Lock Glenoid Component, as well as the Univers Revers Baseplate component.shoulder systems.

The Glenoid IRIS is an instrument system intended for use in total shoulder replacement to facilitate preoperative planning and intraoperative placement of the glenoid implant component. This bundled submission contains four traditional 510(k) submissions associated with Arthrex Glenoid IRIS. All of the submissions correspond to components of the system that are intended for use together to place the guide pin, and subsequently the glenoid implant, in a total shoulder replacement surgery. All of the components (subject devices in the bundled submissions) of Arthrex Glenoid IRIS are indicated for use with the Arthrex lines of Glenoid implants. We would now like to add the Arthrex Vault Lock glenoid implant to this list of compatible/indicated implant systems.

The Arthrex VIP Web Portal is intended for use as a software interface 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 COS technicians. The Arthrex VIP Web Portal is intended for use with the Arthrex Glenoid Intelligent Reusable Instrument System (Arthrex Glenoid IRIS) and with the Arthrex OrthoVis Preoperative Plan. It is indicated for use with the following glenoid implant lines: Arthrex Univers Apex, Arthrex Univers II, and Arthrex Univers Revers.

The ArthrexVIP Web Portal is composed of software intended for use to facilitate upload of medical images, preoperative planning, and plan approval of placement and orientation of total shoulder joint replacement components. Each surgeon user's uploaded images are associated with specific cases and associated with that surgeon's profile. Uploaded images can be downloaded from the portal by COS technicians and used to create preoperative plans (see 510(k) K151568) in the OrthoVis Desktop Software. The surgeon user is then able to login to the ArthrexVIP Web Portal to review the plan and either approve or modify the location and/or orientation of the joint replacement component. The approved plan is then downloaded by COS technicians for production (see 510(k) K151500 and K151568) as part of the Arthrex Glenoid IRIS device.

The Glenoid Intelligent Reusable Instrument System ("Glenoid IRIS") is a patient specific manual instrument system intended to facilitate preoperative planning and intraoperative placement of the central glenoid guide pin used in the preparation of the glenoid in total shoulder systems that utilize a central guide pin for preparing the glenoid to receive the glenoid implant. The Arthrex Glenoid IRIS is indicated for use with the Arthrex Univers Apex, Keeled or Pegged Glenoid components as well as the Univers Revers Baseplate component. The indications for use of the Arthrex shoulder systems with which the Arthex Glenoid IRIS is intended to be used are the same as those described in the labeling for these shoulder systems.

The SmartBase is a reusable instrument that allows the IRI device from the Arthrex Glenoid IRIS system (K151500) to be set according to prescribed lengths and heights for a specific patient's glenoid anatomy. The IRI leg lengths and their respective heights are determined in the OrthoVis software which is a part of the Arthrex Glenoid IRIS system. Along with the IRI leg lengths for each IRI slot and their respective heights, images of where the IRI was planned to sit on the patient's glenoid for the prescribed leg lengths and heights are given. Loading the IRI device according to the prescribed lengths, setting the height of each IRI leg according to the prescribed SmartBase ruler heights, and then placing the IRI on the glenoid according to the preoperative plan images allows the IRI to transfer the guide pin for the surgeon-approved, preoperatively-planned glenoid implant trajectory to the patient in the OR. It provides the same function as the SmartBone (setting the IRI device), which was previously cleared in the predicate, K151500.

The Glenoid Intelligent Reusable Instrument System ("Glenoid IRIS") is a patient specific manual instrument system intended to facilitate preoperative planning and intraoperative placement of the central glenoid guide pin used in the preparation of the glenoid in total shoulder systems that utilize a central guide pin for preparing the glenoid to receive the glenoid implant. The Arthrex Glenoid IRIS is indicated for use with the Arthrex Univers Apex, Keeled or Pegged Glenoid components as well as the Univers Revers Baseplate component. The indications for use of the Arthrex shoulder systems with which the Arthex Glenoid IRIS is intended to be used are the same as those described in the labeling for these shoulder systems.

The Glenoid Intelligent Reusable Instrument System ("Glenoid IRIS") is a patient specific manual instrument system intended to facilitate preoperative planning and intraoperative placement of the central glenoid guide pin used in the preparation of the glenoid in total shoulder systems that utilize a central guide pin for preparing the glenoid to receive the glenoid implant. The Arthrex Glenoid Intelligent Reusable Instrument System described in this submission is identical to the Glenoid IRIS cleared in K142072, except for the following differences: - The Glenoid IRIS for the K142072 clearance was indicated for use with the DePuy family of shoulder replacement systems. The subject device is indicated for use with the Arthrex family of glenoid components, which includes: - o Univers™ II and Univers™ Apex Keeled Glenoid, - O Univers™ II and Univers™ Apex Pegged Glenoid, - o Univers Revers™ Baseplate. - The DePuy implant models in the OrthoVis planning software have been replaced with Arthrex implant models. - -The OrthoVis User's Manual and User Training Manual contain references to the implant company's instructions as to how their glenoid implants should be placed in patients. For this current submission, the User's Manual and User Training Manual have been changed to reflect the approved labeling for how Arthrex instructs these implants to be placed in patients. All other elements of the K142072 clearance are identical to this submission.

The OrthoVis 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 pre-operative software for simulating implant placement and surgical treatment options. The OrthoVis Web Portal is intended for use with the Glenoid Intelligent Reusable Instrument system and with the OrthoVis Preoperative Plan. It is also intended for use with the Arthrex and DePuy shoulder replacement implant systems listed below. - · Arthrex Univers Apex - · Arthrex Univers II - · Arthrex Univers Revers - · DePuy Global AP - DePuy Global StepTech - · DePuy Delta Xtend Reverse The Glenoid Intelligent Reusable Instrument System ("Glenoid IRIS") is a patient specific manual instrument system intended for use to facilitate preoperative planning and intraoperative placement of the central glenoid guide pin used in the preparation of the glenoid in total shoulder systems that utilize a central guide pin for preparing the glenoid to receive the glenoid implant.

The OrthoVis Web Portal is composed of software intended for use to facilitate upload of medical images and preoperative planning and plan approval of placement and orientation of Arthrex and DePuy total shoulder replacement systems. Each surgeon user's uploaded images are grouped into cases and associated with that user's profile. Uploaded images can be downloaded from the portal by COS technicians and used to create preoperative plans (see 510(k) K13367 and K151568). The user is then able to login to the OrthoVis Web Portal to review the preoperative plan and either approve or modify the location and/or orientation of the shoulder replacement component and then approved plan is then available to download by COS technicians for further preoperative planning production (see 510(k) K123122 and K142072) and for download by the user/surgeon.

The Arthrex OrthoVis Preoperative Plan is a preoperative plan created via the OrthoVis software accurate preoperative planning and intraoperative placement of the glenoid component in total shoulder replacement. The Arthrex Preoperative Plan is indicated for use in planning the central glenoid guide pin for the Arthrex Univers™ II and Univers™ Apex Keeled glenoid component, Univers™ II and Univers™ Apex Pegged glenoid component, and the Univers Revers™ Baseplate. The indications for use of the Arthrex shoulder systems with which the Arthex OrthoVis Preoperative Plan is intended to be used are the same as those described in the labeling for these shoulder systems.

The Arthrex OrthoVis Preoperative Plan is a preoperative plan document that is created in the OrthoVis software. A patient CT scan is loaded into the OrthoVis software and the desired bony anatomy can be separated and segmented with OrthoVis tools, allowing extracted and segmented bones (e.g., scapula, humerus) to be virtually implanted with shoulder replacement implants.

The Glenoid Intelligent Reusable Instrument System ("Glenoid IRIS") is a patient specific manual instrument system intended to facilitate preoperative planning and intraoperative placement of the central glenoid guide pin used in the preparation of the glenoid in total shoulder systems that utilize a central guide pin for preparing the glenoid to receive the glenoid implant. The Glenoid IRIS is indicated for use in planning and placing the central glenoid guide pin for the DePuy Global AP Shoulder glenoid component, Global Shoulder StepTech Anchor Peg glenoid component, or Delta Xtend Reverse Shoulder metaglene component as an alternative to the standard instruments provided for placing the guide pin with these implant systems. The indications for use of the DePuy shoulder systems with which the Glenoid IRIS is intended to be used are as those described in the labeling for these shoulder systems except that the Glenoid IRIS is not intended for use in hemishoulder replacement. The Indications for Use of these DePuy shoulder systems are: DePuy Global AP Shoulder System and Global StepTech Anchor Peg Glenoid The DePuy Global AP Shoulder System and Global StepTech Anchor Peg Glenoid are indicated for use in total shoulder replacement surgery for patients suffering from: · A severely painful and/or disabled joint resulting from osteoarthritis or rheumatoid arthritis. · Fracture-dislocation of the proximal humerus where the articular surface is severely comminuted, separated from its blood supply or where the surgeon's experience dictates that alternative methods of treatment are unsatisfactory. · Other difficult clinical problems where shoulder surgery arthrodesis or resection arthroplasty are not acceptable (e.g., revision of a failed primary component). The Global AP Glenoid and StepTech glenoid components are indicated only for use with bone cement. DePuy Delta Xtend Reverse Shoulder System · The Delta Xtend Reverse Shoulder prosthesis is intended for use as total shoulder replacement. · The Delta Xtend Reverse Shoulder prosthesis is indicated for use in a grossly efficient rotator cuff joint with severe arthropathy or a previous failed joint replacement with a grossly deficient rotator cuff joint. • The patient's joint must be anatomically and structurally suited to receive the selected implant(s), and a functional deltoid muscle is necessary to use the device. · In cases of bone defects in the proximal humerus, the monoblock implant should be used and then only in cases where the residual bone permits firm fixation of this implant. · Delta Xtend hemi-shoulder replacement is also indicated for hemi-arthroplasty if the glenoid is fractured intraoperatively. · The metaglene component is HA coated and is intended for cementless use with the addition of screws for fixation. All other components are for cemented use only.

The Glenoid Intelligent Reusable Instrument System described in this submission is identical to the Glenoid IRIS cleared in K123122, except for the following modifications: - In K123122, the IRI legs were plastic, single use, and were shipped sterile in quantities of 2 of each recommended leg length. In this submission, the IRI legs are stainless steel, reusable, and are shipped non-sterile in the Glenoid IRIS instrument tray/carrier/kit for steam sterilization prior to use at the hospital where the procedure will be taking place. Each Glenoid IRIS kit contains a full set of reusable IRI legs. - The SmartBone instruments (SmartBone-Pin Trajectory, SmartBone-Reamed, SmartBone-Fixation Feature Prep, and SmartBone-Implant) are made of a different photopolymer from K123122. -The SmartBone instruments are shipped non-sterile and are sterilized on-site where the procedure will be taking place. -The IRI wrench was removed from the Glenoid IRIS system and the IRI cap was modified to facilitate tightening and loosening the IRI instrument by hand. The Glenoid IRIS instrument tray was made to include a slot that could be used to replace the disassembly feature of the nubs on the IRI wrench. -The SmartBone—Pin Trajectory instrument is pre-marked where the recommended IRI legs contact the SmartBone instrument. The marker is a non-toxic marker that is compatible with steam, EO & Sterrad Sterilization. We performed testing to determine how great the risk of the marking from the marker bleeding and or transferring when wiped with a polar and non-polar solvent. The study indicated that the marker was compatible with steam sterilization and did not undergo bleeding. Likewise, the marker did not transfer to a white rag when rubbed with a polar or non-polar solvent. -The SmartBone mount is made of stainless-steel, is reusable, and is shipped nonsterile as part of the Glenoid IRIS system in a kit/carrier. When the SmartBone is placed on the SmartBone mount, the glenoid is positioned such that vertical is the plane of the scapula. When the SmartBone is set on its base without the SmartBone Mount, the guide pin hole is vertical for ease in setting the IRI. -The Glenoid IRIS system includes a case/tray carrier for ease in shipping, storing, carrying, and organizing the Glenoid IRI device, the Glenoid IRI legs, the SmartBone instrument (or a place to put the SmartBone instrument, when it arrives after having been shipped separately), and the SmartBone Mount. -Minor dimensional and aesthetic marking changes to the IRI components

The OrthoVis Preoperative Plan is a preoperative plan document created via the OrthoVis software that facilitates accurate preoperative planning and intraoperative placement of the glenoid component in total shoulder replacement. The OrthoVis Software and resulting Preoperative Plan is indicated for use with the DePuy Global APTM Shoulder glenoid, Global Shoulder StepTech™ Anchor Peg glenoid, or Delta XtendTM Reverse Shoulder metaglene components. The indications for use of the DePuy shoulder systems with which the OrthoVis Preoperative Plan is intended to be used are the same as those described in 510(k) KI23122.

The OrthoVis Preoperative Plan is a preoperative plan document that is created in OrthoVis software. A patient CT scan is loaded into OrthoVis software and the desired bony anatomy can be separated and segmented with OrthoVis tools, allowing extracted and segmented bones (e.g., scapula, humerus) to be virtually implanted with shoulder replacement implants. OrthoVis currently is used only with the DePuy Global APG glenoid, DePuy Global StepTech, and DePuy Delta Xtend components for total shoulder arthroplasty. OrthoVis can then produce a preoperative plan document (.pdf file), the OrthoVis Preoperative Plan, that contains text, images, and in electronic format, a rotatable 3D model(s) of the implanted component and bone. This preoperative plan document is labeled, via a watermark, as unapproved until the ordering surgeon approves the plan, at which point such labeling is removed and the final plan provided to the ordering surgeon.