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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.

Customize for ankle arthroplasty is intended to be used as a software interface to assist in: - Visualization, modification, validation of the planning of total ankle arthroplasty - Communication of treatment options - Segmentation of CT-scan data - 3D CAD models generation - use x-ray scan information to enhance the planning of ankle arthroplasty - Managing timeline and cases Customize is not intended to be used for - Spine surgeries - Implant and instrument design Experience in usage and clinical assessment are necessary for a proper use of the software. It is to be used for adult patients only and should not be used for diagnostic purposes.

Customize is intended to be used during the preparation of ankle arthroplasties. It visualizes surgical treatment options that were previously created based on 3D CAD files generated from multi-slice DICOM data from a CT scanner. It consists of a single software user interface where the physician can review the CAD files in 3D, CT and X-Ray images in 2D and modify the position and orientation of the different 3D objects. Customize includes an implant library with 3D digital representations of various implant models so that the right implant positioning and sizing can be achieved based on the physician's input. After approval by the physician, the treatment plan is saved on the server and can be used as a reference during surgery. It is also possible to export the treatment plan for further processing such as designing and manufacturing of patient specific devices (the design of those later is done using an external software).

Customize for shoulder arthroplasty is intended to be used as a software interface to assist in: - Visualization, modification, validation of the planning of shoulder arthroplasty - Communication of treatment options - Segmentation of CT-scan data - 3D CAD models generation - Managing timeline and cases Customize is not intended to be used for - Spine surgeries - Implant and instrument design Experience in usage and clinical assessment are necessary for a proper use of the software. It is to be used for adult patients only and should not be used for diagnostic purposes.

Customize is intended to be used during the preparation of shoulder arthroplasties. It visualizes surgical treatment options that were previously created based on 3D CAD files generated from multi-slice DICOM data from a CT scanner. It consists of a single software user interface where the physician can review the CAD files in 3D and modify the position and orientation of the different 3D objects. Customize includes an implant library with 3D digital representations of various implant models so that the right implant positioning and sizing can be achieved based on the physician's input. After approval by the physician, the treatment plan is saved on the server and can be used as a reference during surgery. Customize is prescription use only.

3D-Cut is intended to be used as a surgical instrument to assist in preoperative planning and/or in guiding the marking of bone and/or in guiding surgical instruments in non-acute, non-joint replacing ostector of bone tumors, for femur, tibia and pelvis including sacrum.

3D-Cut is a patient-matched additively manufactured single use surgical instrument (PS). Based on a preoperative planning, the instruments are intended to assist physicians in guiding the marking of bone and guiding surgical instruments in bone tumor resection surgery, excluding joint replacement surgeries. The 3D-Cut instruments are designed starting from patient medical images, computed tomography (CT) and magnetic resonance imaging (MRI) device. The clinician delineates the tumor on the MRI. MRI and the delineated tumor are merged onto the CT which is used to extract the 3D CAD model of the bone. A draft treatment plan is submitted for evaluation to the treating clinician. Upon surgeon's approval, a PSI is designed and again submitted to the clinician. After validation, the PSI is produced using additive manufacturing.