NEW YORK (CNNMoney.com) -- Medtronic's experimental vertebrae device is pretty much a lock to win FDA approval. It's the approval of Medicare that going to be harder to win - and essential for the device's success.

FDA advisers will vote Tuesday on Medtronic's (up $0.03 to $46.23, Charts) Prestige cervical disc system, a hinge-like steel device that is screwed into the upper part of the spine to replace worn-out discs.

Medtronic's experimental spinal implant, the Prestige.

The panel vote is non-binding, but the Food and Drug Administration usually follows the advice of its advisers when deciding whether to approve an experimental product. There seems to be little doubt that the Prestige will win the blessings of the federal agency.

The advisory committee released documents Monday that said the Prestige works at least as well as spinal fusion, a type of surgery that binds vertebrae together through the use of bone grafts.

Jason Wittes, analyst for Leerink Swann, described the Prestige as a "maverick" and said that, if approved, it would be the first disc in the U.S. to be implanted in the cervical, or upper, part of the back. Johnson & Johnson (up $0.37 to $64.16, Charts) and Synthes produce discs for the lumbar, or lower, part of the back.

But even if the Prestige sails through the FDA process, analysts say it will be a harder sell to Medicare. And since insurance is important for expensive devices such as spinal implants, which are beyond the financial means of most patients, that's no small obstacle.

"They're (the devices are) expensive, and so far they're only proven to be equivalent [to spinal fusion,]" said Wittes, referring to the surgical procedure that is used to correct spinal problems.

Wittes said Prestige sales could total $200 million annually for Medtronic, but to reach blockbuster-level sales the device would have to get past the Medicare cost watchers.

"They're (Medtronic) going to want to charge more than the reimbursement initially," said Stephan Ogilvie, analyst for ThinkEquity, referring to Medicare coverage. "That will also slow adoption."

Medtronic, a leader in the medical device industry, totaled $11.3 billion in 2005 sales. The spinal portion of the Minneapolis-based company's business totaled $2.2 billion.

Years from now, Medtronic could find itself competing against Johnson & Johnson, Synthes and Nuvasive (up $0.27 to $21.26, Charts), medical device makers that are also developing cervical discs.

But for the near future, Medtronic faces no direct competition, said Ogilvie of ThinkEquity Partners. Without competition, Ogilvie said the company has the luxury of releasing its product slowly into the market, the better to keep tabs on potential problems.

"Since [Medtronic] has a monopoly on the device, they'll control the release so they have no bad outcomes," said Ogilvie, who projects that annual sales will range from $50 million to $100 million, at least in the beginning.

The analysts interviewed for this story do not own shares of stock in companies mentioned here.

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