Medacta Receives FDA Clearance for MyShoulder Placement Guides
CASTEL SAN PIETRO, 17 December 2019 - Medacta announced today it has received clearance from the U.S. Food and Drug Administration (FDA) for its MyShoulder Placement Guides for shoulder arthroplasty, following approval from the Japanese Ministry of Health, Labour and Welfare (MHLW) earlier this year. These patient-matched, 3D-printed solutions work in conjunction with the Medacta Shoulder System and associated instrumentation to help the surgeon create an accurate and reproducible implant placement specific to each patient's individual anatomy.
The MyShoulder system is the first patient-specific offering in the United States to provide both humeral and glenoid guides, in order to facilitate execution of the surgical plan. Detailed patient modeling, via computed tomography (CT) imaging, supports precise reconstruction of patient bone morphology for a patient-matched fit that helps surgeons improve accuracy both in preoperative planning and surgery.
'Working with the MyShoulder Placement Guides enables me to play a key role in the surgical process from start to finish. Access to pre-operative planning and the support of a dedicated technician are key aspects of the platform and ensure the resulting guides are optimized for each procedure and patient,' said Matthew D. Saltzman, M.D., Associate Professor of Orthopaedic Surgery at the Northwestern Memorial Hospital in Chicago, Illinois. 'This level of collaboration associated with the system, alongside Medacta's robust suite of implants and instruments, creates a thorough solution that's easy to implement in the OR.'
MyShoulder is in line with Medacta's broader focus on personalized surgical approaches, an area of orthopedics the company has advanced through its sophisticated 'MySolutions' technology. In addition to MyShoulder, MySolutions also includes Medacta's MyKnee, MyHip and MySpine platforms, which have resulted in standard-of-care breakthroughs for joint replacement and spine surgery.
'Medacta is dedicated to empowering surgeons through technology. Our goal is to provide solutions that encourage surgeon input at all stages of the surgical process while providing patient-specific designs and insights to support them,' said Francesco Siccardi, Chief Executive Officer of Medacta International. 'We've received incredibly positive feedback from surgeons using our patient-matched solutions in joint and spine and are thrilled to bring this level of precision and collaboration to U.S. surgeons practicing shoulder arthroplasty as well.'
The MyShoulder Placement Guides will also be added to the educational offering of Medacta's Shoulder Learning Centers in the United States organized by the prestigious M.O.R.E. Institute. For more information on MyShoulder and Medacta's shoulder arthroplasty solutions, visit www.medacta.com/EN/myshoulder.
Medacta Group SA
Corrado Farsetta, CFO
Phone: +41 91 696 60 60
Medacta is an international company specializing in the design and production of innovative orthopaedic products and the development of accompanying surgical techniques for joint replacement, spine surgery, and sports medicine. Established in 1999 in Switzerland, Medacta's products and surgical techniques are characterized by innovation. Medacta is a pioneer in developing new offerings on the basis of minimally invasive surgical techniques, in particular its Anterior Minimally Invasive Surgery ('AMIS') technique for hip replacements. Medacta has leveraged its orthopaedic expertise and comprehensive understanding of the human body to develop the sophisticated 'MySolutions' technology, which offers surgeons highly personalized pre-operative planning and implant placement methodologies by creating advanced personalized kinematic models and 3D planning tools for use in hip, knee, shoulder and spine procedures.