Stryker gets FDA nod to use Mako robot for total knee reconstruction

Mako Rio robot-assisted surgery system

Stryker ($SYK) announced that is has received FDA clearance to use its Mako robotic surgery system during total knee construction procedures, as it seeks to capitalize on its $1.65 billion acquisition of Mako Surgical in 2013.

"The ability to include a Mako total knee application with our market leading Triathlon Total Knee System represents a key milestone in reconstructive surgery," said David Floyd, president of the company orthopedics unit. "We are excited about the opportunity to transform orthopedics by furthering the growth of robotic-arm assisted surgery, and by enhancing the surgeon and patient experience."

The company said it plans a limited market release of the new offering by the end of the year. Stryker already uses the Mako to perform partial knee resurfacing.

"Keep in mind it is going to be three quarters, four quarters before we've gone through the necessary training and upgrades and work that's going to be needed to be done to make sure that that launch is truly optimized," said Stryker vice president Katherine Owen in anticipation of the clearance, during the company's July 23 Q2 earnings call.

In March, the company announced FDA clearance to use the Mako for total hip replacement procedures. That launch has not yet been optimized either Owen said during the call: "We are in the process, as I mentioned, around doing the necessary software upgrades that will enable us to start to put our hip implant on the MAKO. We have the clearance, but we have to do that work, and that will continue through this year and into next year as well."

The expanded indications are a significant advance of the company's strategy to differentiate itself by offering most of its implants via the platform, which is supposed be more accurate and deliver better outcomes than traditional manual orthopedic surgery.

Adoption of the Mako has been slower than was expected at the time of the acquisition due to concerns about the device's cost and clinical benefits, but RBC Capital markets analyst Glenn Novarro is bullish. "In total knees, U.S. surgeons expect robotics to represent ~10% of total knee procedures two years from now, ~18% of procedures five years from now, and ~23% of procedures ten years from now," he wrote in March.

During its most recent earnings call, Stryker said it placed 13 Mako robots during Q2 2015, including its first two in Australia. The company sold 9 robots during Q1 and 20 in Q4 2014, all records numbers for those quarters, Owen said.

- read the release

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