FDA Expands Mako Cementless Knee Offering

The FDA has granted 510(k) clearance to Stryker Corporation to combine Mako’s cementless total knee with Triathlon Tritanium.

The company reported on October 16, 2017, that the clearance combines the kinematics of the knee implant with the company’s highly porous biologic fixation technology. “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 (Stryker Orthopaedic Modeling and Analytics).”

The clearance, states the company, “expands the current robotics offering to provide a cementless solution” for orthopedic surgeons seeking a more “predictable surgical experience combined with increased operating room efficiency, biologic fixation and an alternative to bone cement.”

Triathlon Tritanium

According to the company, Tritanium is manufactured from commercially-pure titanium and is a highly porous biologic fixation surface, which closely resembles the structure of cancellous bone. “Stryker’s 3D printing technology allows for this titanium powder to be applied in numerous layers and provides a complex porous structure in appropriate areas of the implant. This allows for strategic positioning of the porous metal matrix in desired zones for greater fixation in the proximal portion of the bone, while avoiding the distal areas that could potentially cause stress shielding.”

Since its launch in 2004, the company says more than two million patients have received a Triathlon knee.

SOMA Design

SOMA is Stryker Orthopaedic’s unique Modeling and Analytics system for the design of orthopedic devices. At the heart of SOMA is a large database of high resolution CT scanned bones from which size, shape, density, and inner and outer cortical boundaries can be drawn. The database is comprised of bones from a diverse population of people that includes a range of age, gender, and ethnicity.

The company believes this type of design is an improvement compared to historical techniques of implant design and manufacturing which involved limited trials on cadavers.

Stuart Simpson, president of Stryker’s Joint Replacement division said 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. 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.”