Sistema
DIAMOND
PRODUCT NAME: ANTERIOR CORPECTOMY CYLINDRICAL MESH SYSTEM
COMMERCIAL NAME: DIAMOND SYSTEM
REFERENCE: 106
MANUFACTURER: Mediimplantes S.A.
MANUFACTURING MATERIAL: Ti 6Al 4V ELI (Extra low interstitial) Alloy for Surgical Implant Applications – UNS R56401, ASTM F136-02.
FUNCTIONAL DESCRIPTION
DIAMOND is a mesh system indicated for patients with pathologies requiring corrections based on lumbar, thoracic, or cervical anterior-approach corpectomies.
The vertebral replacement cylindrical mesh coupling system includes: cylindrical meshes, rings, and simple screws for fastening of the first two elements. Three screws are used on each end of the mesh and provide additional support as well as more resistance to sinking. Furthermore, they help with bone graft containment inside the mesh. The rings come in several designs to couple with each mesh diameter: straight-jagged, A-type jagged inclination, B-type jagged inclination, and non-jagged.
INDICATIONS
Indicated for vertebral body replacement in patients with fractures or tumors, where anterior- approach partial or total corpectomy is performed on thoracic and cervical levels.
STUDIES AND TESTS
– Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model- ASTM F 1717-04
– ASTM E8 Mechanical and metallurgic characterization.
CERTIFICATES
– INVIMA Sanitary Registration N° INVIMA 2018DM-0001064-R1
– ISO 9001 and ISO 13485 Registrations
PRESENTATION AND PACKAGING
Implants from the DIAMOND 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.