456fe01c-a94c-400c-8eec-53631e1c7a43UpdatePublished22023-05-032019-05-06In Commercial DistributionM209198060PrimaryHIBCCSizing Guide 12MM19806618749857BIOPRO, INC.1falsefalsefalsefalsefalsefalsetruefalsetruetruefalsefalsefalseLabeling does not contain MRI Safety InformationtruefalseK06108900013180Orthopaedic 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.falseActiveHWTTemplatefalsetrueMoist Heat or Steam Sterilization