FORT LAUDERDALE, Fla. — MAKO Surgical Corp., a medical device company focused on marketing its advanced robotic-arm solution and its implants for minimally invasive orthopedic knee procedures, announced that it received two 510(k) clearances from the U.S. Food and Drug Administration (FDA) to market both the company's proprietary Version 2.0 Tactile Guidance System (TGS), branded as the MAKO RIO, and its bicompartmental knee resurfacing implant system, branded as RESTORIS MCK. MAKO currently expects to commercially launch both the RIO and the RESTORIS MCK systems in the first half of 2009.
"We believe the advanced proprietary features of our Version 2.0 RIO robotic-arm system and the RESTORIS MCK bicompartmental knee implant system provide the potential to address larger portions of MAKO's target markets," said Maurice R. Ferre, MD, president and CEO of MAKO. "Obtaining the FDA 510(k) clearance for each of these products represents the achievement of a key milestone towards the continuing commercialization of innovative technology that restores patient quality of life."
Source: MAKO Surgical Corp.