Stryker Gets New FDA Clearance for Mako

Posted in Orthopedics by Chris Newmarker on August 7, 2015

CEO Kevin Lobo had previously described total knee clearance as a “catalyst for enhanced growth” for the surgical robot.

Chris Newmarker

FDA has cleared a total knee application for Stryker’s Mako surgical robot arm.

The 510(k) clearance, announced Thursday, adds to the partial knee and total hip applications that the Mako was already cleared for. Stryker is preparing a limited market release for the new application by the end of the year.

"The ability to include a Mako total knee application with our market leading Triathlon Total Knee System represents a key milestone in reconstructive surgery," David K. Floyd, group president of Stryker Orthopaedics, said in a news release.

Stryker paid $1.7 billion to acquire Mako Surgical and its robotic surgery technology in late 2013. The company has placed 42 Mako robots globally in the past three quarters alone, Katherine Owen, Stryker’s vice president of strategy and investor relations, told analysts during a July 23  earnings call transcribed by Seeking Alpha.

Stryker CEO Kevin Lobo said during the same call that he thought the company turned the corner on Mako during the middle of last year, overcoming back order issues.

“We're of course very anxious for the total knee approval which we believe will be another catalyst for enhanced growth, but our organization really has embraced this, the sales force integration is now really humming,” Lobo said at the time. 

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Chris Newmarker is senior editor of Qmed and MPMN. Follow him on Twitter at @newmarker.

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