The PRESTIGE® LP Cervical Disc should only be used by surgeons experienced in the surgical procedure who have undergone adequate hands-on training with this specific device, and are familiar with the implant components, instruments, procedure, clinical applications, biomechanics, adverse events, and risks associated with the PRESTIGE® LP Cervical Disc. A lack of adequate experience and/or training may lead to a higher incidence of adverse events, such as neurological complications.

The safety and effectiveness of this device has not been established in patients with the following conditions: axial neck pain as solitary symptom; not skeletally mature; prior cervical spine surgery, including prior surgery at the index level; fused level adjacent to the level to be treated; facet joint pathology of involved vertebral bodies; spinal metastases; Paget's disease, osteopenia, osteomalacia, or other metabolic bone disease; overt or active bacterial infection, either local or systemic; chronic or acute renal failure or history of renal disease; taking medications known to potentially interfere with bone/soft tissue healing (e.g., steroids); pregnant; diabetes mellitus requiring daily insulin management; extreme obesity as defined by the NIH Clinical Guidelines Body Mass Index (i.e., BMI >= 40); and have not undergone at least six weeks of non-operative treatment or had signs of progression or spinal cord/nerve root compression with continued non-operative care.


Implanted metal alloys release metallic ions into the body (especially those devices with metal-on-metal articulating surfaces). The long term effect of these ions on the body is not known. Patients in the clinical study were instructed to use non-steroidal anti-inflammatory drugs (NSAIDs) for two weeks postoperatively. It has been reported in the literature that short-term postoperative use of NSAIDs may reduce the instance of heterotopic ossification (HO). To reduce the instance of HO, it is recommended that the PRESTIGE® LP device be implanted in subjects able to tolerate the use of NSAIDs for two weeks post-operatively.

Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.

Please see the package insert for the complete list of indications, warnings, precautions, adverse events, clinical results, and other important medical information.

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