066b9b05-dd0e-42a2-8e61-15092b588e12UpdatePublished32023-05-032016-08-08In Commercial Distribution00888912092661PrimaryGS1DJO SURGICAL803-05-103081840873DJO, LLC1TRIAL, LINER 28 X 20 X MP11falsefalsefalsefalsefalsefalsetruefalsefalsefalsefalsefalsetrueLabeling does not contain MRI Safety Informationfalsefalse13180Orthopaedic prosthesis implantation positioning instrument, reusableA hand-held surgical instrument intended to be used during implantation of an orthopaedic prosthesis, either manually or as a computer-assisted surgery (CAS) device, to aid in the navigation/placement of the prosthesis or other instruments [e.g., drill sleeves and guide wires (Kirschner wires), patella saw guide]. It may be used for the following applications: 1) to hold/align/fix/guide other instruments, prostheses, or prosthesis components; 2) to provide relative position landmarks; 3) to ascertain correct spatial orientation or limb alignment; and/or 4) as an interface (non-adaptive) between prosthesis components. This is a reusable device intended to be sterilized prior to use.falseActiveFZXGuide, surgical, instrumentfalsetrueMoist Heat or Steam Sterilization