SPINAL elements


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Spinal Elements, Inc. · 3115 Melrose Dr., Suite 200 Carlsbad, CA 92010 · U.S.A. · 760.607.0121  VERTU® and VERTU® TI-BOND® IMPLANTS AND INSTRUMENTATION This package insert covers the Vertu® and Vertu® Ti-Bond® Cervical System, and Manual Surgical Instruments that are used for the implantation of these systems GENERAL INFORMATION Spinal Elements’ Vertu® and Vertu® Ti-Bond® Cervical Interbody System is composed of an implant body and fixation screws. The implant body is a generally box-shaped device with holes through its body for the placement of graft material. Additionally, it has teeth located on its superior and inferior external surfaces to help keep the device from migrating once placed in its desired location. Each screw hole is lined in its internal surface with a titanium ring insert. Screws pass through screw holes of the implant body and affix to bone to help prevent implant migration. When fully seated, the screw head rests on the titanium insert of the screw hole. Device implant bodies are made from either titanium alloy (Ti-6Al-4V) conforming to ASTM F 136 or ISO 5832-3, polyetheretherketone (PEEK-Optima®) conforming to ASTM F 2026, or PEEK with a coating of commercially pure titanium conforming to ASTM F 1580. Screws are made from Ti-6Al-4V per ASTM F 136 or ISO 5832-3 and Nitinol conforming to ASTM F 2063. All implants are intended for single patient use only and should not be reused (used in additional patients) under any circumstances. Reuse may result in serious injury or death. Components from this system should not be used in conjunction with components from other systems. INDICATIONS  Vertu® and Vertu® Ti-Bond® devices are stand-alone interbody fusion devices intended for spinal fusion procedures at one level from the C2-C3 disc space to the C7-T1 disc space in skeletally mature patients with degenerative disc disease of the cervical spine. DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. Implants are to be implanted via an open, anterior approach and packed with autograft or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft.  Patients must have undergone a regimen of at least six (6) weeks non-operative treatment prior to being treated with these devices. The implant is designed to accommodate two screws. Two screws should be used to ensure adequate fixation of the implant. CONTRAINDICATIONS 1. Patients with known or probable intolerance to the materials used in the manufacture of this device. 2. Patients with infection, inflammation, fever, tumors, elevated white blood count, obesity, pregnancy, mental illness and other medical conditions which would prohibit beneficial surgical outcome. 3. Patients resistant to following post-operative restrictions on movement especially in athletic and occupational activities. 4. Use with components from other systems. 5. Grossly distorted anatomy caused by congenital abnormalities. 6. Any patient that has had prior fusion surgery at the levels to be treated. 7. Any other medical or surgical condition which would preclude the potential benefit of spinal implant surgery. 8. Rapid joint disease, bone absorption, osteopenia. Osteoporosis is a relative contraindication since this condition may limit the degree of obtainable correction, stabilization, and/or the amount of mechanical fixation. 9. Any case where the implant components selected for use would be too large or too small to achieve a successful result. 10. Any patient having inadequate tissue coverage over the operative site or inadequate bone stock or quality. 11. Any patient in which implant utilization would interfere with anatomical structures or expected physiological performance. 12. Any case not described in the indications for use. 13. Reuse or multiple use. WARNINGS Implants and instruments are provided non-sterile. Instruments must be cleaned and sterilized before use. Implants may be processed prior to use and must be sterilized before use. Validated sterilization cycle parameter protocols are noted in the STERILIZATION section of this insert. Implants that have come in direct contact with a patient or bio-contaminants should be disposed of.  INS-Vertu-LA  Page 1 of 6  Rev. 20220311
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File Name: SPINAL elements - INS-Vertu-LA - VERTU and VERTU TI-BOND IMPLANTS and INSTRUMENTATION Instructions for Use - 2022-03.pdf

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