MAKO Surgical Corp. has announced that it received two 510(k) clearances from the US Food and Drug Administration to market both the Company’s proprietary Version 2.0 Tactile Guidance System(tm) (TGS(tm)), branded as the MAKO RIO(tm), and its bicompartmental knee resurfacing implant system, branded as RESTORIS(r) MCK. MAKO currently expects to commercially launch both the RIO(tm) system and the RESTORIS(r) MCK system in the first half of 2009. 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.

Biospace med has announced that data from a clinical study of its FDA-cleared ‘EOS’ 3D x-ray orthopedic imaging system conducted by a Montreal-based hospital-”EOS: A New Breed of X-Ray Imager Using Low-Dose Slot-Scanning to Achieve High-Quality Images”-showed that the EOS ultra-low-dose orthopedic imaging system makes possible “better image quality” than CR imaging while using nearly 10 times less radiation.” EOS is designed to capture head-to-toe images of patients in a standing, weight-bearing position while reducing up to 90% of the radiation dose compared to a conventional x-ray and up to 1000 times less radiation than a conventional CT scan.

DePuy Mitek, Inc. has announced the launch of the HEALIX™ BR Dual Threaded Anchor System, the first suture anchor for arthroscopic rotator cuff repair made with the company’s proprietary BIOCRYL® RAPIDE™ biocomposite material, shown in pre-clinical trials to resorb and promote bone formation within the implant profile2. BIOCRYL RAPIDE has become an important technology platform in orthopedics sports medicine. The biocomposite material, exclusive to DePuy Mitek products, has more than four years of clinical success in more than 100,000 patients. BIOCRYL RAPIDE is currently used in the MILAGRO Bioreplaceable Interference Screw for anterior cruciate ligament (ACL) repair.