PRECICE UNYTE System Instructions for Use

16 Pages

NuVasive Specialized Orthopedics, Inc. PRECICE UNYTE System Instructions for Use Product Description: The PRECICE UNYTE System is composed of an implantable intramedullary nail, locking screws, reusable instruments, and a hand-held External Remote Controller (ERC). The PRECICE UNYTE implants are manufactured from Titanium 6AL-4V per ASTM F136. The PRECICE UNYTE Nail is a sterile single use device that is surgically implanted using the instruments and locking screws. The ERC is used daily after implantation to non-invasively lengthen or shorten the implant. During the implantation procedure, the nail can be adjusted in length to provide an appropriate amount of compression for the proper fracture reduction. Following implantation, the PRECICE UNYTE Nail utilizes distraction osteogenesis to compensate for any limb discrepancy. Traditional intramedullary surgical techniques are used to implant and secure the proximal and distal sections of the PRECICE UNYTE Nail to the target bone. The Magnetic Actuator of the PRECICE UNYTE Nail includes a small internal magnet and gearing. After positioning the External Remote Controller (ERC) against the skin in the vicinity of the internal magnet, activation of the ERC causes the magnet to rotate and either lengthen or shorten the PRECICE UNYTE Nail. The femoral and tibial nails are provided 10mm pre-distracted and the humeral nail is provided 20 mm predistracted to provide compression for fracture reduction. Over a period of days or weeks, sequential distractions can be performed to increase the limb length to compensate for any length discrepancies encountered during the fracture reduction process. Once the physician determines that the implant has achieved its intended use and is no longer required, the PRECICE UNYTE Nail is to be removed using standard surgical techniques. Indications for Use: The PRECICE UNYTE System is indicated for open and closed fracture fixation, pseudoarthrosis, malunions and non-unions, limb lengthening, or bone transport of long bones in adults. Contraindications: • Patients with Gustilo open fracture Classification Grade IIIB or IIIC fractures. • Patients with pre-existing nerve palsies. • Infection or Pathologic conditions of bone such as osteopenia which would impair the ability to securely fix the device. • Metal allergies and sensitivities. • Patients with an irregular bone diameter that would prevent insertion of the PRECICE UNYTE Nail. • Patients in which the PRECICE UNYTE Nail would cross joint spaces or open epiphyseal growth plates. • Patients in which there is an obliterated medullary canal or other conditions that tend to retard healing such as blood supply limitations, peripheral vascular disease or evidence of inadequate vascularity. • Patients unwilling or incapable of following postoperative care instructions. Please refer to the table below for contraindications with regard to weight and maximum distance of the treated limb to the surface of the intramedullary canal.  LC0095- Rev T-2/2022  Page|1
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