PROPHECY<sup>®</sup> Registered with CFDA for Record

Shanghai, China – 13 January, 2015 – MicroPort Orthopedics PROPHECY® Pre-Operative Navigation System was recently registered with China Food and Drug Administration ("CFDA") for the record.
 
The PROPHECY® program registered this time contains four models, respectively to support the use of ADVANCE® Medial-Pivot Knee that is available in the China market and the EVOLUTION® Medial-Pivot Knee that will be soon launched.
 
The PROPHECY® system is designed as patient-specific surgical instrumentation to assist in the positioning of total knee replacement components intra-operatively and in guiding the marking of bone before cutting.
 
It is the first product of MicroPort Orthopedics that combines medical modeling technology and 3D printing. The PROPHECY® system enables surgeons to utilize basic computerized tomography ("CT") or magnetic resonance imagery ("MRI") scans to plan precise implant placement and alignment before surgery. Based on surgeon preferences, the knee is aligned with unobscured anatomic landmarks. Therefore, with PROPHECY® surgeons are able to envision the results of the operation before it actually occurs.
 
In traditional total knee replacement, although with the help of X-ray examination pre-operatively and navigation instruments intra-operatively, surgeons have to largely rely on naked-eye observation and personal experience to position the bone, which is inaccurate and may even lead to operation failure. In contrast, the PROPHECY® program utilizes imaging modeling to develop patient-specific guides that follow the unique curvature of the patient's bone. It is expected to improve accuracy, increase operating room efficiency and allow for greater function of the implants. In addition, PROPHECY® is created to reduce surgical steps and simplify surgery.
 
The PROPHECY® system is consisted of femur guide and tibia guide, and the guides are both available in two versions: Alignment Only and Alignment and Resection.