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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.

TECHFIT Digitally Integrated Surgical Reconstruction Platform (DISRP) System is intended for use as a software system and image segmentation system for the transfer of imaging information from a medical scanner such as a CT based system. The input data file is processed by the DISRP System and the result is an outbut data file that may then be provided as digital models or used as input to a rapid prototyping portion of the system that produces physical outputs including surgical guides and splints for use in maxillofacial surgery. The DISRP System is also intended as a preoperative software tool for simulating / evaluating surgical treatment options. The DISRP system is compatible with the TECHFIT Patient- Specific Maxillofacial System and the TECHFIT Diagnostic Models and should be used in conjunction with expert clinical judgment.

The TECHFIT DISRP SYSTEM is composed by Anatomic Specificx Guiding System and the Digitally Integrated Surgical Reconstruction Platform (DISRP). - . The Digitally Integrated Surgical Reconstruction Platform (DISRP) is a web-based collaboration software for digital surgery case flow management and Orthognathic surgery planning that reflects the production process and allows for the interaction of multiple users: surgeons, sales representatives, and the TECHFIT case planning staff (case planning assistant, case planners, and operations director), using multiple devices. It allows collaboration in the planning process. Detail description of the software can be found in later in this section. - Anatomic Specificx Guiding System is a Patient-Specific single-use device designed to ● assist surgeons in transferring the pre-surgical plan to the operation room. This system includes surqical quides intended for Orthognathic and Reconstructive surgeries in adults. The surgical guides have drilling holes and slots to make osteotomies and ensure the correct positioning of bones and implants. The Anatomic Specificx Guiding System is divided into two categories: Anatomic Specificx Orthognathic Guides and Anatomic Specificx Reconstruction Guides. Anatomic Specificx Orthognathic Guides are classified into Titanium and Resin Surgical Guides. Anatomic Specificx Orthognathic Titanium Guides are manufactured from Commercially Pure (CP) Titanium grade 4; they include mandibular and maxillofacial surgical guides (e.q. Le Fort, Genioplasty, etc). Palatal Splints are also part of Anatomic Specificx Orthognathic Titanium Guides, which are optional quides used in orthognathic surgery to quide and support the correct teeth positioning and validate the patient's final occlusion. Anatomic Specificx Orthognathic Resin Guides are manufactured through rapid prototyping using the Form 3B and Form 4B printers and Biomed Clear Resin from Formlabs. These guides include Le Fort and genioplasty surgical guides. During surgery, resin surgical guides must be used with slot, drill, and screw metal sleeves. Slot sleeves are made from commercially pure grade 4 titanium, while drill and screw sleeves are made from alloyed titanium (Ti6Al4V). All sleeves are manufactured by machining. The resin quides also include splints (intermediate, final, and palatal), which are optional quides used in orthognathic surgery to quide and support the correct teeth positioning and validate the patient's final occlusion. Anatomic Specificx Reconstruction Guides The Anatomic Specificx Reconstruction Guides are intended for mandibular and maxillofacial surqical procedures in adults, using patient grafts/flaps for reconstruction. These guides are made from Commercially Pure (CP) grade 4 titanium, produced through machining and finished with an anodizing process. They are intended for use in the anatomical sites of the maxilla, mandible and fibula. The reconstruction guides provide transfer of the pre-surgical plan to the operating room, facilitating placement and fixation of the patient's bone grafts/flaps at the surgical site.

The traCMF Solution is intended for use as a software system and image segmentation system for the transfer of imaging information from a medical scanner such as a CT-based system. The input data file is processed by the tmCMF Solution, and the result is an output data file that may then be provided as digital models or used as input to a rapid prototyping portion of the system that produces physical outputs including anatomical models, surgical guides, and dental splints for use in maxillofacial and mandibular surgery. The surgical guides and dental splints are intended to the maxillofacial and mandibular bone in mandibular surgery. The tmCMF Solution is also intended as a preoperative software tool for simulating/evaluating surgical treatment options.

The TechMah CMF (tmCMF) Solution is a family of personalized product solutions for trauma and reconstruction procedures in the mandible and midface. The solution is comprised of Surgeon Review Tool (SRT) software, and maxillofacial and mandibular surqical instruments (surgical quides, anatomical models, and dental splints). The surqical instruments are patient-specific devices and are designed utilizing CT and dental scan patient image data. Surgical guides are patient-specific devices or templates that are based on preoperative software planning and are designed to fit a specific patient. These guides are used to assist a surgeon in transferring the pre-operative plan to the surgery by guiding the marking of bone for plate fixation screws and the position of the osteotomy marking slots. Surgical guides are available for treatment (maxilla and mandible) and harvesting (fibula, iliac crest, and scapula). Guides can be used in conjunction with anatomical models to verify anatomical positioning and fit. Anatomical models are patient-specific models that are based on pre-operative anatomy and surgical planning specific to a patient. These models are used to assist a surgeon in transferring the pre-operative plan to the surgery by representing preoperative, intra-operative, and post-operative anatomical models as guidance. Anatomical models are available for treatment (maxilla and mandible), and harvesting (fibula, iliac crest, and scapula) anatomy. Anatomical models can be used to check quide fit. Dental splints are patient-specific devices or templates that are based on preoperative software surgical planning and are designed to fit a specific patient. Dental splints are available as single splint desired occlusions or combined splint-in-splint option. These templates are used to assist a surgeon in transferring the pre-operative plan to the surgery by guiding the dental alignment of bone and teeth. The Surgeon Review Tool (SRT) software is used by surgeons for the review and approval of surgical plans and surgical instrument designs. The SRT software is accessed through a web interface from a surgeon's device.

TECHFIT Digitally Integrated Surgical Reconstruction Platform (DISRP) System is intended for use as a software system and image segmentation system for the transfer of imaging information from a medical scanner such as a CT based system. The input data file is processed by the DISRP System and the result is an output data file that may then be provided as digital models or used as input to a rapid prototyping portion of the system that produces physical outputs including surgical guides and splints for use in maxillofacial surgery. The DISRP System is also intended as a preoperative software tool for simulating / evaluating surgical treatment options. The DISRP system is compatible with the TECHFIT Patient- Specific Maxillofacial System and the TECHFIT Diagnostic Models and should be used in conjunction with expert clinical judgment.

The TECHFIT DISRP SYSTEM is composed by Orthognathic Surgical Guides and the Digitally Integrated Surgical Reconstruction Platform (DISRP). Digitally Integrated Surgical Reconstruction Platform (DISRP) The Digitally Integrated Surgical Reconstruction Platform (DISRP) is a web-based collaboration software for digital surgery case flow management and Orthognathic surgery planning that reflects the production process and allows for the interaction of multiple users: surgeons, sales representatives, and the TECHFIT case planning staff (case planning assistant, case planners, and operations director), using multiple devices. It allows easy collaboration in the planning process. Being web-based allows immediate and convenient sharing without the installation or maintenance of the application at the user's end. Orthognathic Surgical Guides Orthognathic Surgical Guides are Patient-Specific single use devices that are designed to assist the surgeon in transferring the pre-surgical plan to the operation room. Surgical Guides are intended for Orthognathic surgeries in adults and have drilling holes and slots for making drillings and osteotomies, as well as they guide the correct positioning of bones and implants. Orthognathic Surgical Guided into two types: Resin Orthognathic Surgical Guides and Machined Orthognathic Surgical Guides. - Resin Orthognathic Surgical Guides Resin Orthognathic Surgical Guides include surgical guides and splints. Surgical Guides consist of the Le Fort and Genioplasty surgical quides, which are composed of a body that is manufactured by TECHFIT Digital Surgery and produced by rapid prototyping with the Form 3B printer and Biomed Clear Resin from Formlabs, Somerville, United States. In surgery Surgical Guides must be used with Metal Sleeves. There are three types of metal sleeves: slot metal sleeve, drill metal sleeve and screw metal sleeve. The slot, drill and screw metal sleeves are manually fitted by the healthcare professional during surgery into the slots, drilling holes and fixation holes of the surgical guide. The metal sleeves are produced from commercially pure titanium grade 4 through machining and are manufactured equivalent to the TECHFIT Patient-Specific Maxillofacial System (K203282) and AFFINITY Proximal Tibia System (K220199). In addition, the Metal Sleeves are single-use and patient-specific accessories. The Splints are optional quides used in orthognathic surgery to quide to the correct teeth positioning and to validate the patient's final occlusion. The Splints are manufactured by TECHFIT Digital Surgery and produced by rapid prototyping using the Form 3B printer and Biomed Clear Resin from Formlabs, Somerville, United States. - Machined Orthognathic Surgical Guides Machined Orthognathic Surgical Guides consist of the Le Fort and Genioplasty surgical guides that are manufactured from the same material (commercially pure titanium grade 4) and in a manufacturing process equivalent to the TECHFIT Patient-Specific Maxillofacial System (K203282) and AFFINITY Proximal Tibia System (K220199) manufactured through machining. Machined Orthognathic Surgical Guides and Metal Sleeves are manufactured with the same material and same manufacturing process.

The MedCAD® AccuPlan® System is intended for use as a software system and image segmentation system for the transfer of imaging information from a medical scanner such as a CT based system. The input data file is processed by the MedCAD® AccuPlan® System and the result is an output data file that may then be provided as digital models or used as input to a rapid prototyping portion of the system that produces physical outputs including anatomical models, surgical guides, and dental splints for use in maxillofacial surgery. The surgical guides and dental splints are intended to be used for the maxillofacial bone in maxillofacial surgery. The MedCAD® AccuPlan® System is also intended as a pre-operative software tool for simulating / evaluating surgical treatment options.

The MedCAD® AccuPlan® System is a collection of software and associated additive manufacturing equipment intended to provide a variety of outputs to support orthognathic or reconstructive surgery. The system uses electronic medical images of the patient's anatomy or stone castings made from the patient anatomy with input from the physician, to manipulate original patient images for planning and executing surgery. The patient specific outputs from the system includes anatomical models, dental splints, surgical guides, and patient-specific case reports. Following the MedCAD® Quality System and specific Work Instructions, trained employees utilize Commercial Off-The-Shelf (COTS) software to manipulate 3-D medical scan images which can include Computed Tomography (CT), Cone Beam CT (CBCT), and/or 3-D scan images from patient physical models (stone models of the patient's teeth) to create patient-specific physical and digital outputs. The process requires clinical input and review from the physician during planning and prior to delivery of the final outputs. While the process and dataflow vary somewhat based on the requirements of a given patient and physician, the following description outlines the functions of key sub-components of the system, and how they interact to produce the defined system outputs. It should be noted that the system is operated only by trained MedCAD employees, and the physician does not directly input information. The physician provides input for model manipulation and interactive feedback through viewing of digital models of system outputs that are modified by the engineer during the planning session. The MedCAD® AccuPlan® System is made up of 4 individual pieces of software for the design and various manufacturing equipment integrated to provide a range of anatomical models (physical and digital), dental splints, surgical guides, and patient-specific planning reports for reconstructive surgery in the maxillofacial region. The MedCAD® AccuPlan® System requires an input 3-D image file from medical imaging systems (i.e. - CT) and/or implant file. This input is then used, with support from the prescribing physician to provide the following potential outputs to support reconstructive surgery. Each system output is designed with physician input and reviewed by the physician prior to finalization. All outputs are used only with direct physician involvement to reduce the criticality of the outputs. System outputs include: - Anatomical Models - Surgical Guides - Dental Splints - Patient-Specific Case Reports The purpose of this submission was to add titanium cutting / drilling guides to the family of available patient specific outputs. Cutting and drilling instruments can only be used with titanium cutting / drilling guides. Polymer guides are to be used for marking and positioning of anatomy only.

EmbedMed is intended for use as a software system and image segmentation system for the transfer of imaging information from a medical scanner such as a CT based system. The is processed by the system, and the result is an output data file. This file may then be provided as digital models or used an input to an additive manufacturing portion of the system. The additive manufacturing portion of the system produces physical outputs including anatomical models and surgical guides for use in maxillofacial surgeries. EmbedMed is also intended as a pre-operative software tool for simulating/evaluating surgical treatment options.

EmbedMed utilizes Commercial Off-The-Shelf (COTS) software to manipulate 3D medical images to create digital and additive manufactured, patient-specific physical anatomical models and surgical guides for use in surgical procedures. Imaging data files are obtained from the surgeons for treatment planning and various patient-specific products that are manufactured with biocompatible photopolymer resins using additive manufacturing (stereolithography).

The OMF ASP System is intended for use as a software system and image segmentation system for the transfer of imaging information from a medical scanner such as a CT based system. The input data file is processed by the OMF ASP System, and the result is an output data file that may then be provided as digital models or used as input to an additive manufacturing portion of the system that produces physical outputs including anatomical models, templates, and surgical guides for use in maxillofacial surgery. The OMF ASP System is also intended as a pre-operative software tool for simulating/evaluating surgical treatment options.

The Oromaxillofacial Advanced Surgical Planning (OMF ASP) System utilizes Commercial Off-the-Shelf (COTS) software to manipulate 3D medical images (CT-based systems) with surgeon input, and to produce digital and physical patient specific outputs including surgical plans, anatomic models, templates, and surgical guides for planning and performing maxillofacial surgeries. The system utilizes medical imaging, such as CT-based imaging data of the patient's anatomy to create surgical plans with input from the physician to inform surgical decisions and guide the surgical procedure. The system produces a variety of patient specific to the maxillofacial region including anatomic models (physical and digital), physical surgical templates and/or guides, and patient specific case reports. The system utilizes additive manufacturing to create patient specific guides, and anatomical models.

The OsteoPlan™ System is intended for use as a software system and image segmentation system for the transfer of imaging information from a medical scanner such as a CT based system. The input data file is processed by the OsteoPlan™ System and the result is an output data file that may then be provided as digital models or used as input to the additive manufacturing portion of the system that produces physical outputs including anatomic models and splints for use in maxillofacial surgery. The OsteoPlan System is also intended as a pre-operative software tool for simulating / evaluating surgical treatment options.

OsteoMed uses computer aided modeling to assist the physician with planning complex maxillofacial surgeries. Specifically, the OsteoPlan™ System provides patient-specific anatomical models, splints, and patient-specific surgical plans and digital files of the surgical plan to assist physicians with maxillofacial surgeries. Outputs of the OsteoPlan™ System are designed with physician input and reviewed by the physician prior to finalization and distribution. All outputs are manufactured by OsteoMed using additive manufacturing (SLS and SLA), only with direct physician involvement to reduce the criticality of the outputs. The system uses electronic medical images of the patient anatomy (CT and CBCT) with input from the physician to create the plan and splints for executing surgery. Off-the-shelf (OTS) software is used for surgical planning. The outputs of the system include Orthognathic Occlusal Splints, Case Reports, and Anatomic models. The splints are offered in commonly used forms, in both intermediate and final positioning, and some are available with ligature holes. Case reports are digital and physical documents created to lay out the surgical plan, dictated by the surgeon, and show outputs of the OsteoPlan™ system that will be used to translate the plan during surgery. Anatomic models are tools provided to physicians for complex anatomy visualization or to preplan surgery with an accurate physical representation of patient anatomy. Anatomic models may include maxilla, mandible, or skull models.

CenterMed Patient Matched Assisted Surgical Planning (ASP) System is intended for use as a software system and image segmentation system for the transfer of imaging information from a medical scanner such as a CT based system. The input data file is processed by the ASP system and the result is an output data file. This file may then be provided as digital models or used as input to a rapid prototyping portion of the system that produces physical outputs including anatomical models, surgical splints and surgical planning case reports for use in maxillofacial surgery. CenterMed Patient Matched ASP System is also intended as a pre-operative software tool for simulating/evaluating surgical treatment options.

CenterMed Patient Matched Assisted Surgical Planning (ASP) System is a combination of software design and additive manufacturing for customized virtual pre-surgical treatment planning in maxillofacial reconstruction and orthognathic surgeries. The system processes patients' imaging data files obtained from the surgeons for treatment planning and outputs various patient-specific products (both physical and digital), including surgical guides, anatomical models, surgical splints, and surgical planning case reports. The physical products (surgical guides, anatomical models and surgical splints) are manufactured with biocompatible polyamide (PA-12) using additive manufacturing (Selective Laser Sintering).

coDiagnostiX is an implant planning and surgery planning software tool intended for use by dental professionals who have appropriate knowledge in the field of application. The software reads imaging information output from medical scanners such as CBCT or CT scanners. It is indicated for pre-operative simulation and evaluation of patient anatomy, dental implant placement, surgical instrument positioning, and surgical treatment options, in edentulous, partial edentulous or dentition situations, which may require a surgical guide. It is further indicated for the user to design such guides for, alone or in combination, the guiding of a surgical path along a trajectory or a profile, or to help evaluate a surgical preparation or step. coDiagnostiX software allows for surgical guide export to a validated manufacturing center or to the point of care. Manufacturing at the point of care requires a validated process using CAM equipment (additive manufacturing system, including software and associated tooling) and compatible material (biocompatible and sterilizable). A surgical guide may require to be used with accessories.

The main uses and capabilities of the coDiagnostiX software are unchanged from the primary predicate version. As in the primary predicate version, it is a software for dental surgical treatment planning. It is designed for the evaluation and analysis of 3-dimensional datasets and the precise image-guided and reproducible preoperative planning of dental surgeries. The first main steps in its workflow include the patient image data being received from CBCT (Cone Beam Computed Tomography) or CT. The data in DICOM format is then read with the coDiagnostiX DICOM transfer module according to the standard, converted into 3-dimensional datasets and stored in a database. The pre-operative planning is performed by the computation of several views (such as a virtual Orthopantomogram or a 3-dimensional reconstruction of the image dataset), by the analysis of the image data, and the placement of surgical items (i.e. sleeves, implants) upon the given views. The pre-operative planning is then followed as decided by the design of a corresponding surgical guide that reflects the assigned placement of the surgical items. Additional functions are available to the user for refinement of the preoperative planning, such as: - · Active measurement tools, length and angle, for the assessment of surgical treatment options: - · Nerve module to assist in distinguishing the nervus mandibularis canal; - 3D sectional views through the jaw for fine adjustment of surgical treatment options; . - Segmentation module for coloring several areas inside the slice dataset, e.g., jawbone, . native teeth, or types of tissue such as bone or skin, and creating a 3D reconstruction for the dataset; - Parallelizing function for the adjustment of adjacent images; and - · Bone densitometry assessment, with a density statistic in areas of interest. All working steps are automatically saved to the patient file may contain multiple surgical treatment plan proposals which allows the user to choose the ideal surgical treatment plan. The output file of the surgical guide and/or the guided surgical is then generated from the final surgical treatment plan. coDiagnostiX software allows for surgical guide export to a validated manufacturing center or to the point of care. Manufacturing at the point of care requires a validated process using CAM equipment (additive manufacturing system, including software and associated tooling) and compatible material (biocompatible and sterilizable). A surgical quide may require to be used with accessories.