FDA clears Stryker’s total knee for Mako robot-assisted surgery device

Stryker (NYSE:SYK) said yesterday that it won 510(k) clearance from the FDA for a total knee tool for the Mako Surgical robot-assisted surgery platform it bought in 2013.

Stryker now has Mako-compatible offerings for total and partial knee replacement and total hip replacement, the company said.

“The ability to include a Mako total knee application with our market leading Triathlon total knee system represents a key milestone in reconstructive surgery,” Stryker Orthopaedics president David Floyd said in prepared remarks. “We are excited about the opportunity to transform orthopaedics by furthering the growth of robotic-arm assisted surgery, and by enhancing the surgeon and patient experience.”

Stryker said it plans to have the total knee option on the U.S. market by the end of the year in a limited release.

Stryker paid $1.7 billion for Mako, which had developed the Rio robotic surgery system, but the deal was slower to pay off than the Kalamazoo, Mich.-based orthopedics giant expected. By the end of 2014, however, Mako was firing on all cylinders, selling 20 Mako systems during the 4th quarter – a 150% increase over Q3 014 and more than were sold during the previous 3 quarters combined.

In March Stryker launched a total hip replacement tool for the Mako system.

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