GENERIC NAME: ANTERIOR CERVICAL FIXATION SYSTEM
COMMERCIAL NAME: ICARO
MANUFACTURER: Mediimplantes S.A
FABRICATION MATERIAL: Ti 6Al 4V ELI (Extra low interstitial) Alloy for Surgical Implant Applications – UNS R56401, ASTM F136-02
ICARO is a system designed for use on cervical segments of the spine. Plates of the system are designed to perform anterior unicortical fixation on cervical segments in order to achieve immobilization and stability. Such plates are available in different sizes to achieve from one and up to four segments of fixation.
The screws are available in different lengths and diameters and are easily inserted thanks to their self-threading mechanism.
Screw length selection has to be done considering vertebral body size in order to achieve superior stability inside.
– Degenerative cervical disc cases
– Cervical tumors and trauma
– Cervical pseudarthrosis-associated instability
– Cervical Malformations
– Instability associated with single or multiple-level cervical corpectomy.
– Post-traumatic cervical deformities
– Cervical canal stenosis
STUDIES AND TESTS
– Standard Specifications and Test Methods for Components Used in the Surgical Fixation of the Spinal Skeletal System – ASTM F 2193-02.
– Standard Specification and Test Method for Metallic Bone Plates – ASTM F382 – 99.
– Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model – ASTM F1717-04
– ISO 10993 Cytotoxicity Biocompatibility Test
– ISO 9001 / ISO 13485 Certifications
– INVIMA Sanitary Registration Nr. 2018DM-0001065-R1
PRESENTATION AND PACKAGING
Implants from the ICARO System are provided unsterilized, individually packaged, and individually laser-marked. Each laser marking shows: product code, lot number, MEDIIMPLANTES logo, material symbol (Ti), and use-specific dimensions. Laser markings are permanent and allow for product traceability, even after implantation.
Primary Packaging: medical-grade paper bag for products to be sterilized and a laminated polyester film with a security band. It’s provided with non-toxic chemical indicators, fit for commercial sterilization methods, allowing for internal monitoring of sterilization parameters.
Secondary Packaging: Organizing racks that protect the implant from any possible mechanical damage caused by product movement to other locations.
Tertiary Packaging: Aluminum cases with safety mechanisms that contain all available organizing racks to display in an organized fashion for the surgeon’s use.
STORAGE AND AVAILABILITY
Immediate availability and easy storage. Does not need refrigeration nor any special handling procedures asides from maintaining cleanliness conditions to guarantee sterilization.