Mako Surgical knee surgery robot gains 510(k) clearance
This article was originally published in The Gray Sheet
Executive Summary
Launch in the first half of 2009 of the firm's RIO Tactile Guidance System version 2.0 robotic-arm and Restoris MCK bicompartmental knee resurfacing implant is planned by the company following receipt of two related 510(k) clearances, announced Dec. 2. The Ft. Lauderdale, Fla., firm launched version 1.0 of the system in 2006 for unicompartmental knee procedures and went public in February. The Tactile Guidance System, previously referred to as the Haptic Guidance System, incorporates patient-specific visualization to help prepare the knee joint for minimally invasive placement of resurfacing implants (1"The Gray Sheet" Oct. 22, 2007, p. 17)
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