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news.Mako Surgical, a medical device company, has received two 510(k) clearances from the FDA to market both the company's proprietary Version 2.0 Tactile Guidance System, branded as the Mako Rio, and its bicompartmental knee resurfacing implant system, branded as Restoris MCK.
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According to the company, the Mako Tactile Guidance System (TGS) is a surgeon-interactive tactile platform that incorporates a robotic arm and patient-specific visualization technology and prepares the knee joint for the precise and consistently reproducible insertion and alignment of resurfacing implants through a minimal incision.
This FDA-cleared TGS allows surgeons to provide a tissue-sparing, bone resurfacing procedure called MAKOplasty to a large, yet underserved patient-specific population suffering from early- to mid-stage osteoarthritic knee disease, the company said.
Mako currently expects to commercially launch both the Rio system and the Restoris MCK system in the first half of 2009.
Maurice Ferre, president and CEO of Mako, said: “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.
“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.”