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The MedCAD® AccuStride™ System is intended to be used as a surgical instrument to assist in preoperative planning and/or in guiding the marking of bone and/or guide surgical instruments in nonacute, non-joint replacing osteotomies in the foot for adult and pediatric patients 12 years of age and older. The MedCAD® AccuStride™ System surgical guides are intended for single use only. The MedCAD® AccuStride™ System surgical guides should only be used when the anatomic landmarks necessary for pre-operative planning can be clearly identified on the patient's radiographic images (i.e., CT).

The MedCAD® AccuStride™ System is a collection of two individual pieces of software and associated additive manufacturing equipment intended to provide a variety of outputs to support non-acute, nonjoint replacing osteotomies in the foot. The system uses electronic medical images of the patient's anatomy or 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, 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 Computed Tomography (CT) images to create patient-specific physical and digital outputs. The process requires clinical input and review from the physician during and prior to delivery of the final 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® AccuPlate® 3DTi Patient-Specific Plating System is intended for use in the stabilization, fixation, and reconstruction of the maxillofacial / midface and mandibular skeletal regions in adolescents (greater than 12 to 21 years of age) and adults.

The MedCAD AccuPlate® 3DTi Patient-Specific Plating System is a metal bone plate used in conjunction with commercially available, non-locking metal bone screws for the fixation to bone in orbital, midface / maxillofacial, and non-continuity mandibular operations. The design and dimensions of each plate within the envelope specification is based upon the patient's anatomical data (CT scan, CBCT scan, or MRI), and the intended anatomy to be fixated as determined from input provided by the surgeon. The subject device is not intended to be bent or modified in surgery. If for any reason the surgeon chooses not to use the subject device in surgery, they may use any of the commercially available plates to complete the surgery. The subject device is additively manufactured from Ti-6AL-4V Extra Low Interstitial (ELI) titanium alloy, provided non-sterile, must be sterilized prior to use, and is intended for single use only. Plates are fastened to bone using commercially available non-locking bone screws with diameters ranging from 1.5mm to 2.7mm and lengths ranging from 3.5mm to 22mm.

MedCAD® AccuPlan® Orthopedics 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 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 of the fibula and ilium. surgical guides for harvesting bone grafts from the fibula or ilium, and surgical planning case reports for use in maxillofacial reconstructive surgeries. MedCAD® AccuPlan® Orthopedics System is also intended as a pre-operative software tool for simulating / evaluating surgical treatment options. The MedCAD® AccuPlan® Orthopedics System is indicated for use in adolescents (greater than 12 to 21 years of age) and adults.

The MedCAD® AccuPlan® Orthopedics System is a collection of software and associated additive manufacturing equipment intended to provide a variety of outputs to support harvesting of bone to support maxillofacial reconstructive surgeries. The system uses electronic medical images of the patient's anatomy with input from the physician to manipulate original patient images for planning and executing surgery. The patient specific outputs from the system include anatomical models, 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 Computed Tomography (CT) images to create patient-specific physical and digital outputs. The process requires clinical input and review from the physician during 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® Orthopedics System is made up of two individual pieces of software for the design and various manufacturing equipment integrated to provide a range of anatomical models (physical and digital), surgical guides, and patient-specific planning reports for harvesting of bone from the fibula and ilium for use in maxillofacial reconstructive surgeries. The MedCAD® AccuPlan® Orthopedics System requires an input 3-D image file from medical imaging systems (i.e., CT). This input is then used, with support from the prescribing physician to provide the following potential outputs to support maxillofacial reconstructive surgery. Each system output is designed with physician inout 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 - Patient-Specific Case Reports

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.

The MedCAD® AccuShape® Titanium Patient-Specific Cranial Implant is designed individually for each patient and intended to correct defects / replace bony voids in the cranial skeleton.

The MedCAD® AccuShape® Titanium Patient-Specific Cranial Implant is a preformed non-alterable cranioplasty plate that cannot be altered or reshaped at the time of surgery and is designed to be implanted in a patient to repair a skull defect. The subject device is composed of commercially pure (CP) Grade 2 titanium per ASTM F67. The manufacturing process is subtractive manufacturing (CNC milled) from models created and developed from patient specific CT Scan Data. The software used in this process is identical to the software used in the predicate device (K110684). The device is designed to have, as requested by the physician, drainage holes over the defect void area, fixation holes over an onlay area, and retractions and other features that fall within the approved design envelope. All designs must be approved by the physician prior to manufacture.

The MedCAD® AccuPlate® Patient-Specific Plate is intended for prescription use in oral and maxillofacial surgery, trauma and reconstructive surgery. Specific Indications for Use: - Primary mandibular reconstruction with bone graft - Temporary bridging until delayed secondary reconstruction - Secondary mandibular reconstruction - Comminuted mandibular fractures - Fractures of edentulous and/or atrophic mandibles - Unstable mandibular fractures - Maxillary reconstruction with or without bone graft - Maxillary trauma

MedCAD® AccuPlate® Patient-Specific Plates are metal bone plates used in conjunction with commercially available metal bone screws for the fixation to bone, specifically in the areas of the mandible and maxilla. The design and dimensions of each plate within the envelope specification is based upon the patient's anatomical data (CT scan, CBCT scan, or MRI), and the intended anatomy to be fixated as determined from input provided by the surgeon. The plates are designed by MedCAD in consultation with the surgeon and manufactured by MedCAD only. MedCAD® AccuPlate® Patient-Specific Plates are not intended to be bent or modified in surgery. The MedCAD® AccuPlate® Patient-Specific Plates are manufactured from commercially pure titanium, are provided non-sterilized prior to use, and are intended for single use only. Plates are fastened to bone using commercially available bone screws with diameters ranging from 2.0 mm to 2.7 mm and lengths ranging from 4.0 mm to 23.0 mm.

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 including anatomical models, surgical guides, and dental splints for use in maxillofacial 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 preoperative 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, surgical quides, dental splints, and patient-specific case reports.

The MedCAD AccuShape™ PEEK Patient Specific Cranial Implant is designed individually for each patient and intended to correct defects / replace bony voids in the cranial skeleton.

The MedCAD AccuShape™ PEEK Patient Specific Cranial Implant devices are individually sized and shaped implantable prosthetic cranioplasty plates intended to correct defects / replace voids in the cranial skeleton of a specific patient. The implants are designed using the patient's CT imaging data and precision manufactured from implantable grade polyether-ether-ketone (PEEK) material. The devices have a nominal thickness of 3mm, ranging from 2-5mm depending on the anatomical location. The device can be supplied as one or as multiple parts due to material constraints and/or the complexity of the device, with each part ranging in size from 10 x 10 (mm) to 200 x 200 (mm). The implants are provided with 2mm drainage holes spaced 10 mm apart from center to center with an edge margin of 10 mm. The devices are non-pyrogenic and are provided non-sterile for sterilization by the physician prior to implantation. The implants are attached to the native bone with commercially available cranioplasty fasteners.