3ba9443e-d74d-4118-a09c-7753752c4ba7UpdatePublished42023-05-032017-08-07In Commercial Distribution00888912094856PrimaryGS1DJO SURGICAL803-08-038154074504Encore Medical, L.P.1TRIAL, CLP-R, SIZE4falsefalsefalsefalsefalsefalsetruefalsefalsefalsefalsefalsetrueLabeling 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