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Paragon 28® MAVEN™ Patient-Specific Instrumentation (PSI) system
The Paragon 28® MAVEN™ Patient Specific Instrumentation (PSI) system is intended to assist a surgeon with preoperative planning and transfer of the preoperative plan to the surgery in total ankle replacement procedures. The system contains several physical and digital outputs including patient-specific anatomical models and guides (physical outputs); and a patient-specific case report (digital or documentation output). The MAVEN™ PSI System is for use with the APEX 3D™ Total Ankle Replacement System. The contraindications, complications, adverse reactions, warnings and precautions of the APEX 3D™ Total Ankle Replacement System should be considered when using the MAVEN™ PSI System. The APEX 3D™ Total Ankle Replacement System Instructions for Use P10-IFU-0001 can be found at www.paragon28.com/ifus.
Alignment. Orientation. Positioning. The MAVEN PSI System utilizes surgeon inputs and computer assisted processing technology to achieve accurate tibiotalar alignment and implant placement to reduce potential for eccentric loads, wear debris and osteolysis.2,3
Minimal joint preparation required.
Surgical Planning Case Reports:
- Are generated based on surgeon inputs and segments of the patient’s CT scanned anatomy
- Address all 6 degrees of rotational and translational orientation
- Allow for enhanced pre-operative visualization of anatomic structures, bone resection levels and help to identify anatomic abnormalities
- Depict APEX 3D™ System Tibia & Talus Implant sizes in simulated implantation
CT Scanning Protocols:
CT protocols are available in both weightbearing and simulated weight-bearing scanning options • Feature a comprehensive continuous knee scan, 5 cm proximal to the knee joint through the bottom of the foot for optimal visualization
- Incorporates 1.25 mm maximum slice spacing for optimal resolution
The MAVEN™ Patient-Specific Instrumentation System is intended to be used as patient specific surgical instrumentation to assist in the positioning of total ankle replacement components intraoperatively and in guiding the marking of bone before cutting. The MAVEN™ Patient-Specific Instrumentation System is intended for use with the Paragon 28® APEX 3D™ Total Ankle Replacement System and its cleared indications for use, provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging CT scans. The MAVEN™ Patient-Specific Instrumentation System is intended for single use only. The Paragon 28® TAR Patient-Specific Case Reports are intended for use with the Paragon 28® APEX 3D™ Total Ankle Replacement System and its cleared indications for use, provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging CT scans.
All applications of the MAVEN™ PSI System that are not defined by the indications are contraindicated. In addition, surgical success can be adversely affected by: • Patients with significant changes to anatomy occurring after the medical scan used for product definition
• To avoid potentially serious allergic reactions, ensure that the patient is not allergic to the materials used in the guides prior to use. • To avoid serious injury, patient identification on guides and reports must be verified and confirmed against patient identification prior to use. • Device(s) are single use only and designed for use with a specific patient only. All unused devices must be destroyed upon the conclusion of the case for which the devices were designed. • Guides are designed for a specific patient. To avoid the potential for serious injury, guides should not be modified in any way. • Do not attempt a surgical procedure with faulty, damaged or suspect instruments or case reports. Inspect all components preoperatively to assure utility. Inspect holes to ensure no debris is present. • MAVEN™ PSI guides are shipped in a non-sterilized state. To avoid possibility of infection, open, clean and sterilize per provided instructions before use. • These instruments are created based on patient-specific data which may be subject to change at varying rates depending on the patient condition. It is up to the medical provider to determine if the patient’s condition or anatomy may have changed sufficiently to require redesign of the device. • The surgeon is held liable for complications associated with incorrect indication or surgical technique or incorrect patient information and consequent incorrect patient behavior. • Do not to drop or contaminate the device during surgery. • Improper placement, positioning, and fixation of the instruments may result in unusual stress conditions and a subsequent reduction in service life of the total ankle replacement components. • Do not use other manufacturer’s instruments or implants in conjunction with the MAVEN™ PSI System.
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