inViZia® Anterior Cervical Plate System

The inViZia Anterior Cervical Plate System consists of:

• Cervical plates
• Locking caps

Fixed- and variable-angle bone screws (these are the same bone screws used in the Trinica Anterior Cervical Plate System) Instrumentation necessary for implantation of the system.

All implant components are made from titanium alloy (Ti-6Al-4V). The inViZia Anterior Cervical Plate System is intended to provide stabilization of the cervical vertebrae for the indications below. The fixation construct consists of a cervical plate that is attached to the vertebral body of the cervical spine with self-tapping and self-drilling bone screws using an anterior approach. Bone screws are available for fixed-angle or variable-angle implantation. These are the same screws used in the Trinica Anterior Cervical Plate System. The inViZia Anterior Cervical Plate System is intended to be removed after solid fusion has occurred..

Indications

The inViZia Anterior Cervical Plate System is designed for anterior interbody screw fixation of the cervical spine at levels C2–T1.

The inViZia Anterior Cervical Plate System is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusions in patients with degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumors, deformity (defined as kyphosis, lordosis or scoliosis), pseudoarthrosis and/or failed previous fusions.

Warning: This device is not approved for screw attachment to the posterior elements (pedicles) of the cervical, thoracic or lumbar spine.

Contraindications

• Overt infection or distant foci of infections
• Local inflammation, with or without fever or leukocytosis
• Pregnancy
• Diseases or conditions other than those specifically described in the Indications section
• Use in the posterior elements (pedicles) of the cervical, thoracic or lumbar vertebrae
• Where attempted correction exceeds the limits of physiologic conditions
• Uncooperative patient or patient with neurologic disorders rendering the patient incapable of following instructions
• Metabolic disorders that may impair bone formation
• Inadequate bone stock to support the device Inability to restrict high activity level
• Obesity
• Poor prognosis for good wound healing (e.g., decubitis ulcer, end-stage diabetes, severe protein deficiency and/or malnutrition)

Warnings

Some metals, polymers, chemicals and other materials used with orthopedic implants have been known to cause cancer and other adverse body reactions, or reports in the literature have suggested such causation. Any factor that causes chronic damage to tissues may be oncogenic. Cancer can metastasize from soft tissue sites (lung, breast, digestive system and others) to bone, including areas adjacent to implants, or it can be seeded to these locations during operative and diagnostic procedures (such as biopsies). Paget disease has been reported to progress to cancer; surgical candidates suffering from this disease should be warned accordingly.

Implantation of foreign material in tissues can elicit an inflammatory reaction. Current literature suggests that wear debris (including metal, polyethylene, ceramic, and cement particles) can initiate the process of histiocytic granuloma formation and consequent osteolysis and loosening. Metal sensitivity has been reported following exposure to orthopedic implants. The most common metallic sensitivities (nickel, cobalt and chromium) are present in medical grade stainless steel and cobalt-chrome alloys.

inViZia Anterior Cervical Plate System is a temporary internal fixation device. Internal fixation devices are designed to stabilize the operative site during the normal healing process. After healing occurs, these devices serve no functional purpose and must be removed. Implant removal should be followed by adequate postoperative management to avoid fracture or refracture.

Precautions

The inViZia Anterior Cervical Plate System instrumentation should only be used after the surgeon has had adequate training in this method of fixation and has become thoroughly knowledgeable about the spinal anatomy and biomechanics. A surgical technique for the inViZia Anterior Cervical Plate System is available upon request. This technique is not a substitute for training and is for general informational purposes only.

The inViZia System uses the Trinica System bone screws and plate bender. Components from other anterior cervical plating systems, however, should not be used with the inViZia System because compatibility has not been established.

Do not use implants made from dissimilar metals (such as cobalt chromium-molybdenum alloy or stainless steel) in contact with components of the inViZia Anterior Cervical Plate System; otherwise, galvanic corrosion may occur.

If contouring of the implant is necessary for optimal fit, the contouring should be gradual and avoid any notching or scratching of the implant(s) surface. The plates must not be repeatedly or excessively bent. Do not reverse bend the plate.

All implants and some instruments are intended for singleuse only; refer to the product label to determine whether the instrument is intended for single-use only. Single-use devices should not be re-used. Possible risks associated with re-use of single-use devices include:

• Mechanical malfunction
• Transmission of infectious agents