7e2c63be-41b0-4c1c-8d67-425b1a683a26UpdatePublished32023-05-032016-06-15In Commercial Distribution00888912092074PrimaryGS1DJO SURGICAL803-05-016081840873DJO, LLC1TRIAL, LINER 22 X 0 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