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Surgical Guides and Anatomical Models:
The MedCAD® AccuStride™ System surgical guides and anatomical models are intended to be used as surgical instruments to assist in preoperative planning and/or in guiding the marking of bone and/or guiding surgical instruments in non-acute, 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).

Fixation Plates:
The MedCAD® AccuStride™ System fixation plates are indicated for use in trauma, general surgery, and reconstructive procedures of the foot for adult and pediatric patients 12 years of age and older. The MedCAD® AccuStride™ System fixation plates are intended for single use only. The MedCAD® AccuStride™ System fixation plates 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 operations in the foot. The system uses electronic medical images of the patient's anatomy and 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, fixation plates, and patient-specific case reports.

The MedCAD® AccuStride™ System includes patient specific metal bone plating used in conjunction with commercially available metal bone screws for the fixation to bone in trauma, general surgery, and reconstructive procedures of the foot. The design and dimensions of each plate within the envelope specification is based upon the patient's anatomical data (i.e., CT scan), 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. Plates are additively manufactured from Ti-6AL-4V Extra Low Interstitial (ELI) titanium alloy and are provided clean but non-sterile for end-user sterilization. Plates are fastened using commercially available locking and non-locking bone screws with diameters ranging from 2.0mm to 4.0mm and lengths ranging from 10mm to 60mm. Plates have been pre-validated for use with locking and non-locking screws from the Osteomed Extremilock Foot Plating System (K131445) and the Osteomed Extremilock Ankle Plating System (K133691). When use of an alternate screw to the pre-validated screw offerings is desired, users must consult the Surgical Technique Guide for information.

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 planning and prior to delivery of the final outputs. 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.

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