The ShapeMatch Cutting Guide is a single-use, disposable cutting guide. They are used for marking bone cutting prior to surgery and as surgical instrumentation to assist in the positioning of the knee replacement components during surgery. Concerns for this device are that the cutting guide does not meet FDA parameters and does not meet the parameters entered into the program by the doctor. These deficiencies result in misalignment, joint instability, fracture, limited mobility, chronic pain, and many times can lead to the need for revision surgery.