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

By Julie A. Vetalice

Stryker (SYK) received FDA 510(k) clearance to market the Mako total knee application with Triathlon cementless components (cruciate-retaining and posteriorly-stabilized femoral components, tibial baseplates and patellar components), Triathlon All Poly tibial components and Triathlon TS (total stabilizer) inserts.

Full commercial launch of the first Mako total knee application occurred in 1Q17, well after its 3Q15 FDA clearance, allowing SYK ample time to optimize training protocols.

The Tritanium tibial baseplate and metal-backed patella components are built with Stryker's AMagine additive manufacturing technology and are designed with the aid of SOMA, the Stryker Modeling and Analytics system comprising a database of bone images from a diverse population. SOMA is used to optimize the fit of orthopaedic devices for a broad range of patients. (Similarly, Zimmer Biomet's Persona Partial knee was designed with use of the ZiBRA™ Anatomical Modeling System to analyze a database of thousands of bones across a diverse global population.)

Sources: Stryker Corporation; ORTHOWORLD Inc.

Product Labels: Knee Replacement, Robot-Assisted Systems

Tags: 510(k) Clearance, Regulatory