PRECICE STRYDE System Instructions for Use

12 Pages

NuVasive Specialized Orthopedics, Inc. PRECICE STRYDE™ System Instructions for Use Product Description: The PRECICE STRYDE™ System is composed of an implantable intramedullary nail, locking screws, reusable instruments, and a hand-held External Remote Controller (ERC). The PRECICE STRYDE™ nail is a sterile, single-use device that is surgically implanted using the instruments and locking screws for osteoplasty lengthening utilizing distraction osteogenesis. The ERC is used daily after implantation to non-invasively lengthen or shorten the implant to a prescribed length. 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 STRYDE™ System utilizes distraction osteogenesis to lengthen the limb. Traditional intramedullary surgical techniques are used to implant and secure the proximal and distal sections of the PRECICE STRYDE™ nail to the target bone. The PRECICE STRYDE™ nail includes a small internal magnet and gearing. After positioning the External Remote Controller (ERC) against the skin over the internal magnet, activation of the ERC causes the magnet to rotate and either lengthen or shorten the nail. During the surgical implantation procedure and after the nail has been secured to the bone, the nail can be shortened up to 10mm for femoral and tibial implants to provide compression for fracture reduction. Over a period of days, weeks, or months, sequential distractions are used to produce the target limb length or compensate for any length discrepancies encountered during the fracture reduction process. The PRECICE STRYDE™ nail remains implanted until bone consolidation has been completed. Once the physician determines that the nail has achieved its intended use and is no longer required, it is removed using standard surgical techniques. Intended Use: The PRECICE STRYDE™ System is intended for limb lengthening, open and closed fracture fixation, pseudoarthrosis, mal-unions, non-unions, or bone transport of long bones. Contraindications: • • • • • • •  •  Infection or pathologic conditions of bone such as osteopenia which would impair the ability to securely fix the device. Patients with Gustilo open fracture Classification Grade IIIB or IIIC fractures Patients with pre-existing nerve palsies Metal allergies and sensitivities. Patients with an irregular bone diameter that would prevent insertion of the PRECICE STRYDE™ nail. Patients in which the PRECICE STRYDE™ 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.  LC0259-L-6/2022  1 |Page
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File Name: NuVasive - LC0259 - PRECICE STRYDE System Instructions for Use - 2022-06 - Rev L.pdf

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