Stryker Receives FDA Clearance for Cementless Mako Total Knee with Triathlon® Tritanium®


New Offering Strengthens Stryker's Leadership Position in Robotic Technology

Stryker's Joint Replacement division today announced that its cementless Mako Total Knee with Triathlon Tritanium has received 510(k) market clearance by the U.S. Food and Drug Administration.

Triathlon Tritanium combines the kinematics of Stryker's market leading Triathlon knee implant with the latest in highly porous biologic fixation technology for a knee system like no other.  The innovation of Tritanium's tibial baseplate and metal-backed patella components are enabled by Stryker's proprietary AMagine additive manufacturing technology and are SOMA-designed. 

With cementless procedures rising in popularity and becoming a fast-growing trend1, Mako Total Knee with Triathlon Tritanium expands the current robotics offering to provide a cementless solution for orthopaedic surgeons seeking a more predictable surgical experience combined with increased operating room efficiency, biologic fixation and an alternative to bone cement.

"With the rise in demand for cementless knee technology, we believe this new offering can have a positive impact on procedural efficiency and patient outcomes," said Stuart Simpson, President, Stryker's Joint Replacement division.  "We're excited to continue to lead in robotic technology and combine two of our most advanced and differentiated products to provide surgeons with the ability to transform orthopaedic surgery."

1.  Table 54: Primary TKA Implant Market. US Markets for Large-Joint Reconstructive Implants 2013. Millennium Research Group. March 2013. Pg. 84

SOURCE: Stryker