Stryker’s Mako Total Knee Application Receives FDA Clearance

Stryker plans a limited U.S. market release of its Mako total knee application by the end of the year, following the receipt of 510(k) clearance from the FDA.

The Mako total knee tool is intended for use with the Mako Surgical robot-assisted surgery platform, which Stryker bought for $1.7 billion in 2013.

The clearance means Stryker now has Mako-compatible offerings for both total and partial knee replacement and total hip replacement. “The ability to include a Mako total knee application with our market-leading Triathlon total knee system represents a key milestone in reconstructive surgery, the company says. — Michael Cipriano