Stryker Launches Mako Total Knee Application

By Julie A. Vetalice

Stryker announced commercial launch of the Mako robotic-arm assisted total knee application. Mako is now the only robotic technology that can be used in total hip, total knee and partial knee replacement.

The application uses Stryker's Triathlon Total Knee and CT-based 3D modeling of bone anatomy to create a patient-specific surgical plan, identifying implant sizing, orientation and alignment. The total knee application received 510(k) clearance in 3Q15, and entered limited launch.

Through 2016, >83,000 Mako-assisted procedures have been performed using >350 systems placed in the U.S. Of these procedures, >1,400 addressed the total knee.

In 2005, MAKO Surgical (formerly known as ZKAT) closed on a $20MM Series B round of private equity financing to support product development and establish initial clinical sites for MAKOplasty, allowing surgeons to digitally sculpt and preserve bone tissue through small portals during early-stage knee treatments.

Throughout the 2000s, the company secured a variety of FDA 510(k) clearances, among them Version 2.0 of its Tactile Guidance System™ (TGS™), branded as the MAKO RIO™, and its bicompartmental knee resurfacing implant, RESTORIS® MCK. The products launched in early 2009 for use in partial knee resurfacing. MAKOplasty for total hip was introduced in 2011.

In 2013, the company acquired assets of Stanmore Implants related to its Sculptor Robotic Guidance Arm, as well as Pipeline Biomedical's orthopaedic devices and instruments for use with robotic devices and manual medical procedures. At the end of that year, Mako was itself acquired by Stryker.

Stryker is displaying its technologies at AAOS 2017 in Booth #3133.

Sources: Stryker Corporation; ORTHOWORLD Inc.

Product Labels: Knee Replacement, Robot-Assisted Systems

Tags: Product Launch